Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND)
DIAMOND
A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal, Parallel Group Study of Patiromer for the Management of Hyperkalemia in Subjects Receiving Renin Angiotensin Aldosterone System Inhibitor (RAASi) Medications for the Treatment of Heart Failure (DIAMOND)
2 other identifiers
interventional
1,195
21 countries
415
Brief Summary
The purpose of this study is to assess the effects of patiromer compared with placebo on serum K+ in HF patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2019
415 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2019
CompletedFirst Posted
Study publicly available on registry
March 25, 2019
CompletedStudy Start
First participant enrolled
April 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 2, 2021
CompletedResults Posted
Study results publicly available
February 24, 2023
CompletedFebruary 24, 2023
February 1, 2023
2.4 years
March 12, 2019
August 25, 2022
February 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in Serum K+ Levels From Baseline
Adjusted mean changes in serum K+ from Baseline.
Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo
Secondary Outcomes (5)
CIF Estimates of the Time to First Hyperkalemia Event With Serum K+ Level > 5.5 mEq/l Over Time
From Day 1/Baseline to week 90
CIF Estimates of the Reduction of the MRA Dose Below Target Dose Over Time
From Day 1/Baseline to week 102
Investigator-reported Events of Hyperkalemia
Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo
Hyperkalemia-related Hard Outcomes Endpoints
Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo
RAASi Use Score
Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo
Study Arms (2)
Group 1: Patiromer
EXPERIMENTALSubjects will be randomized to receive a daily dose of patiromer with possible dose adjustments based on subsequent local serum potassium levels.
Group 2: Placebo
PLACEBO COMPARATORSubjects will be randomized to receive a daily dose of placebo with possible dose adjustments based on subsequent local serum potassium levels.
Interventions
The starting dose of patiromer will be 1 packet/day and may be taken either with food or without food. Based upon the patiromer treatment algorithm patiromer may be increased by 1 packet per day in intervals of at least 1 week (± 3 days). For subjects who become hypokalemic, patiromer may be decreased to a minimum of 0 packets/day. Doses of patiromer will be 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).
The starting dose of placebo will be 1 packet/day and may be taken either with food or without food. Based upon the placebo treatment algorithm placebo may be increased by 1 packet per day in intervals of at least 1 week (± 3 days). For subjects who become hypokalemic, placebo may be decreased to a minimum of 0 packets/day. Doses of placebo will be 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).
Eligibility Criteria
You may qualify if:
- Age at least 18 years or greater
- Symptomatic low ejection fraction heart failure (weak heart muscle)
- Receiving any dose of a beta blocker for the treatment of HF (unless not able to tolerate)
- Kidney function not more than mild or moderately impaired
- High blood potassium (\>5.0 mEq/L) currently while receiving medications for heart failure OR normal blood potassium currently but previously had high potassium in the12 months prior to screening which caused a permanent reduction or discontinuation of heart failure medications
- Hospitalization for heart failure or treatment in an out patient setting with intravenous medications within the last 12 months before screening.
You may not qualify if:
- Current acute decompensated HF, within 4 weeks before screening. Subjects with a discharge from a hospitalization for acute decompensation of HF longer than 4 weeks before screening may be included
- Significant primary aortic or mitral valvular heart disease (except secondary mitral regurgitation due to left ventricular dilatation)
- Heart transplantation or planned heart transplantation (i.e., currently on a heart transplant waiting list) during the study period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vifor Pharma, Inc.lead
- Syneos Healthcollaborator
Study Sites (415)
Investigator Site 11-080
Alexander City, Alabama, 35010, United States
Investigator Site 11-041
Huntsville, Alabama, 35801, United States
Investigator Site 11-153
Phoenix, Arizona, 85108, United States
Investigator Site 11-097
Tucson, Arizona, 85724, United States
Investigator Site 11-052
Bakersfield, California, 93308, United States
Investigator Site 11-174
Fremont, California, 94538, United States
Investigator Site 11-136
Fresno, California, 93720, United States
Investigator Site 11-102
Huntington Beach, California, 92648, United States
Investigator Site 11-162
La Jolla, California, 92037, United States
Investigator Site 11-048
La Mesa, California, 91942, United States
Investigator Site 11-111
Laguna Hills, California, 92653, United States
Investigator Site 11-017
Long Beach, California, 90813, United States
Investigator Site 11-128
Northridge, California, 91324, United States
Investigator Site 11-035
Pasadena, California, 91105, United States
Investigator Site 11-044
Sacramento, California, 95816, United States
Investigator Site 11-135
San Diego, California, 92119, United States
Investigator Site 11-086
San Diego, California, 92161, United States
Investigator Site 11-112
Santa Ana, California, 92705, United States
Investigator Site 11-101
Stockton, California, 95204, United States
Investigator Site 11-047
Thousand Oaks, California, 91360, United States
Investigator Site 11-057
Van Nuys, California, 91401, United States
Investigator Site 11-058
West Hills, California, 91307, United States
Investigator Site 11-095
Aurora, Colorado, 80045, United States
Investigator Site 11-168
Altamonte Springs, Florida, 32701, United States
Investigator Site 11-106
Boynton Beach, Florida, 33437, United States
Investigator Site 11-028
Brandon, Florida, 33511, United States
Investigator Site 11-003
Doral, Florida, 33166, United States
Investigator Site 11-138
Gainesville, Florida, 32608, United States
Investigator Site 11-164
Greenacres City, Florida, 33467, United States
Investigator Site 11-078
Homestead, Florida, 33033, United States
Investigator Site 11-004
Jacksonville, Florida, 32224-1865, United States
Investigator Site 11-179
Jacksonville, Florida, 32277, United States
Investigator Site 11-122
Medley, Florida, 33166, United States
Investigator Site 11-115
Miami, Florida, 33125, United States
Investigator Site 11-125
Miami, Florida, 33144, United States
Investigator Site 11-005
Miami, Florida, 33155, United States
Research Site 11-001
Miami Lakes, Florida, 33014, United States
Research Site 11-002
Miami Lakes, Florida, 33014, United States
Investigator Site 11-032
North Miami Beach, Florida, 33169, United States
Investigator Site 11-171
Orlando, Florida, 32807, United States
Investigator Site 11-025
Orlando, Florida, 32810, United States
Investigator Site 11-087
Orlando, Florida, 32819, United States
Investigator Site 11-177
Pembroke Pines, Florida, 33026, United States
Investigator Site 11-144
Pompano Beach, Florida, 33064, United States
Investigator Site 11-099
Tamarac, Florida, 33321, United States
Investigator Site 11-090
Tampa, Florida, 33606, United States
Investigator Site 11-163
Tampa, Florida, 33614, United States
Investigator Site 11-109
Atlanta, Georgia, 30303, United States
Investigator Site 11-015
Columbus, Georgia, 31904, United States
Investigator Site 11-141
Macon, Georgia, 31201, United States
Investigator Site 11-031
Arlington Heights, Illinois, 60005, United States
Investigator Site 11-051
Hazel Crest, Illinois, 60429, United States
Investigator Site 11-063
Peoria, Illinois, 61602, United States
Investigator Site 11-137
Peoria, Illinois, 61614, United States
Investigator Site 11-117
Merrillville, Indiana, 46410, United States
Investigator Site 11-129
Munster, Indiana, 46321, United States
Investigator Site 11-069
Richmond, Indiana, 47347, United States
Investigator Site 11-061
Owensboro, Kentucky, 42303, United States
Investigator Site 11-183
Opelousas, Louisiana, 70570, United States
Investigator Site 11-022
West Monroe, Louisiana, 71291, United States
Investigator Site 11-027
Baltimore, Maryland, 21229, United States
Investigator Site 11-023
Columbia, Maryland, 21044, United States
Investigator Site 11-132
Boston, Massachusetts, 02215, United States
Investigator Site 11-123
Detroit, Michigan, 48201, United States
Investigator Site 11-121
Livonia, Michigan, 48154, United States
Investigator Site 11-076
Rochester, Michigan, 48307, United States
Investigator Site 11-189
Rochester, Michigan, 48307, United States
Investigator Site 11-068
Jackson, Mississippi, 39216, United States
Investigator Site 11-154
Kansas City, Missouri, 64111, United States
Investigator Site 11-094
St Louis, Missouri, 63110, United States
Investigator Site 11-071
Lincoln, Nebraska, 68256-9797, United States
Investigator Site 11-049
Las Vegas, Nevada, 89102, United States
Investigator Site 11-145
North Las Vegas, Nevada, 89086, United States
Investigator Site 11-088
Haddon Heights, New Jersey, 08035, United States
Investigator Site 11-054
Linden, New Jersey, 07036, United States
Investigator Site 11-148
New Brunswick, New Jersey, 08901, United States
Investigator Site 11-107
Newark, New Jersey, 07102, United States
Investigator Site 11-116
Albuquerque, New Mexico, 87109, United States
Investigator Site 11-151
Brooklyn, New York, 11203-2012, United States
Investigator Site 11-126
Brooklyn, New York, 11234, United States
Investigator Site 11-073
Buffalo, New York, 14215-1145, United States
Investigator Site 11-040
Manhasset, New York, 11030, United States
Investigator Site 11-053
Richmond Hill, New York, 11419, United States
Investigator Site 11-081
Staten Island, New York, 10310, United States
Investigator Site 11-021
Stony Brook, New York, 11794, United States
Investigator Site 11-127
The Bronx, New York, 10461, United States
Investigator Site 11-120
Charlotte, North Carolina, 28204, United States
Investigator Site 11-075
Charlotte, North Carolina, 28207, United States
Investigator Site 11-018
Greenville, North Carolina, 27834, United States
Investigator Site 11-157
Lumberton, North Carolina, 28358, United States
Investigator Site 11-149
Columbus, Ohio, 43214, United States
Investigator Site 11-064
Lorain, Ohio, 44053, United States
Investigator Site 11-042
Marion, Ohio, 43302-6416, United States
Investigator Site 11-187
Toledo, Ohio, 43623, United States
Investigator Site 11-074
Bartlesville, Oklahoma, 74006, United States
Investigator Site 11-124
Oklahoma City, Oklahoma, 73112, United States
Investigator Site 11-056
Hillsboro, Oregon, 97123, United States
Investigator Site 11-169
Portland, Oregon, 97239, United States
Investigator Site 11-165
Erie, Pennsylvania, 16507, United States
Investigator Site 11-082
Hershey, Pennsylvania, 17033, United States
Investigator Site 11-110
Greenville, South Carolina, 29607, United States
Investigator Site 11-098
Greenwood, South Carolina, 29646, United States
Investigator Site 11-119
Lancaster, South Carolina, 29720, United States
Investigator Site 11-133
Rock Hill, South Carolina, 29732, United States
Investigator Site 11-152
Chattanooga, Tennessee, 37403, United States
Investigator Site 11-091
Jackson, Tennessee, 38301, United States
Investigator Site 11-142
Memphis, Tennessee, 38117, United States
Investigator Site 11-083
Memphis, Tennessee, 38138, United States
Investigator Site 11-134
Tullahoma, Tennessee, 37388, United States
Investigator Site 11-104
Allen, Texas, 75013, United States
Investigator Site 11-185
Allen, Texas, 75013, United States
Investigator Site 11-070
Amarillo, Texas, 79106, United States
Investigator Site 11-176
Dallas, Texas, 75231, United States
Investigator Site 11-092
Dallas, Texas, 75246, United States
Investigator Site 11-170
Denison, Texas, 75020, United States
Investigator Site 11-060
Fort Worth, Texas, 76104, United States
Investigator Site 11-072
Gonzales, Texas, 78629, United States
Investigator Site 11-140
Houston, Texas, 77002, United States
Investigator Site 11-089
Houston, Texas, 77070, United States
Investigator Site 11-146
Houston, Texas, 77077, United States
Investigator Site 11-156
Houston, Texas, 77094, United States
Investigator Site 11-034
Katy, Texas, 77450, United States
Investigator Site 11-029
Lampasas, Texas, 76550, United States
Investigator Site 11-046
McKinney, Texas, 75071, United States
Investigator Site 11-147
San Antonio, Texas, 78215, United States
Investigator Site 11-085
San Antonio, Texas, 78229, United States
Investigator Site 11-161
Sugar Land, Texas, 77479, United States
Investigator Site 11-160
Webster, Texas, 77598, United States
Investigator Site 11-178
Salt Lake City, Utah, 84132, United States
Investigator Site 11-158
Norfolk, Virginia, 23507, United States
Investigator Site 11-188
Norfolk, Virginia, 23510, United States
Investigator Site 11-065
Morgantown, West Virginia, 26506, United States
Investigator Site 11-045
Milwaukee, Wisconsin, 53226, United States
Investigator Site 21-006
Ciudad Autonoma de Buenos Aire, Buenos Aires, C1093AAS, Argentina
Investigator Site 21-007
Ciudadela, Buenos Aires, B1702BML, Argentina
Investigator Site 21-019
Mar del Plata, Buenos Aires, B7602CBM, Argentina
Investigator Site 21-020
Ramos Mejía, Buenos Aires, B1704ETD, Argentina
Investigator Site 21-004
San Nicolás de los Arroyos, Buenos Aires, B2900DPA, Argentina
Investigator Site 21-011
Córdoba, Córdoba Province, 5000, Argentina
Investigator Site 21-021
Córdoba, Córdoba Province, X5000EVQ, Argentina
Investigator Site 21-014
Córdoba, Córdoba Province, X5002AOQ, Argentina
Investigator Site 21-015
Villa María, Córdoba Province, 5900, Argentina
Investigator Site 21-010
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Investigator Site 21-012
Buenos Aires, 1425, Argentina
Investigator Site 21-003
Buenos Aires, C1023AAB, Argentina
Investigator Site 21-018
Buenos Aires, C1407GTN, Argentina
Investigator Site 21-008
Buenos Aires, C1430CKE, Argentina
Investigator Site 21-017
Salta, A4406BPF, Argentina
Investigator Site 21-005
San Luis, 5700, Argentina
Investigator Site 21-009
Santa Fe, 3000, Argentina
Investigator Site 44-002
Mechelen, Antwerp, 2800, Belgium
Investigator Site 44-001
Ghent, Oost Vlaanderen, 9000, Belgium
Investigator Site 44-005
Aalst, B-9300, Belgium
Investigator Site 44-009
Brussels, 1200, Belgium
Investigator Site 44-003
Genk, 3600, Belgium
Investigator Site 44-008
Hasselt, 3500, Belgium
Investigator Site 44-007
Leuven, 3000, Belgium
Investigator Site 44-006
Liège, 4000, Belgium
Investigator Site 44-010
Roeselare, 8800, Belgium
Investigator Site 44-004
Yvoir, 5530, Belgium
Investigator Site 22-019
Fortaleza, Ceará, 60430-370, Brazil
Investigator Site 22-013
Fortaleza, Ceará, 60840-285, Brazil
Investigator Site 22-012
Vitória, Espírito Santo, 29043-260, Brazil
Investigator Site 22-021
Salvador, Estado de Bahia, 40170-130, Brazil
Investigator Site 22-023
Brasília, Federal District, 70710-100, Brazil
Investigator Site 22-011
Belo Horizonte, Minas Gerais, 30110-934, Brazil
Investigator Site 22-005
Belo Horizonte, Minas Gerais, 30150-240, Brazil
Investigator Site 22-004
Uberlândia, Minas Gerais, 38411-186, Brazil
Investigator Site 22-010
Campina Grande do Sul, Paraná, 83430-000, Brazil
Investigator Site 22-008
Canoas, Rio Grande do Sul, 92425-900, Brazil
Investigator Site 22-003
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Investigator Site 22-015
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Investigator Site 22-002
Porto Alegre, Rio Grande do Sul, 90620-001, Brazil
Investigator Site 22-009
Porto Alegre, Rio Grande do Sul, 90840-440, Brazil
Investigator Site 22-025
Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
Investigator Site 22-017
Blumenau, Santa Catarina, 89020-430, Brazil
Investigator Site 22-007
Aracaju, Sergipe, 49055-530, Brazil
Investigator Site 22-016
Campinas, São Paulo, 13083-970, Brazil
Investigator Site 22-018
Ribeirão Preto, São Paulo, 14051-140, Brazil
Investigator Site 22-020
São José do Rio Preto, São Paulo, 15015-210, Brazil
Investigator Site 22-024
Rio de Janeiro, 20241-180, Brazil
Investigator Site 22-014
São Paulo, 05403-000, Brazil
Investigator Site 22-022
São Paulo, 09080-110, Brazil
Investigator Site 61-003
Burgas, 8000, Bulgaria
Investigator Site 61-002
Pleven, 5800, Bulgaria
Investigator Site 61-004
Plovdiv, 4002, Bulgaria
Investigator Site 61-010
Rousse, 7002, Bulgaria
Investigator Site 61-009
Sofia, 1233, Bulgaria
Investigator Site 61-008
Sofia, 1379, Bulgaria
Investigator Site 61-005
Sofia, 1431, Bulgaria
Investigator Site 61-006
Sofia, 1527, Bulgaria
Investigator Site 12-005
Winnipeg, Manitoba, R2H 2A6, Canada
Investigator Site 12-013
St. John's, Newfoundland and Labrador, A1B3V6, Canada
Investigator Site 12-008
Cambridge, Ontario, N1R7R1, Canada
Investigator Site 12-012
London, Ontario, N6A 5A5, Canada
Investigator Site 12-010
Newmarket, Ontario, L3Y 2P6, Canada
Investigator Site 12-002
Toronto, Ontario, M5B 1W8, Canada
Investigator Site 12-009
Greenfield Park, Quebec, J4V 2G8, Canada
Investigator Site 12-006
Sherbrooke, Quebec, J1G 2E8, Canada
Investigator Site 12-004
Trois-Rivières, Quebec, G8Z 3R9, Canada
Investigator Site 62-004
Bílina, 41801, Czechia
Investigator Site 62-019
Brno, 65691, Czechia
Investigator Site 62-017
Havířov, 73601, Czechia
Investigator Site 62-005
Havlíčkův Brod, 58022, Czechia
Investigator Site 62-013
Liberec, 46001, Czechia
Investigator Site 62-015
Litovel, 78401, Czechia
Investigator Site 62-010
Mariánské Lázně, 35301, Czechia
Investigator Site 62-018
Náchod, 54701, Czechia
Investigator Site 62-001
Prague, 12808, Czechia
Investigator Site 62-012
Prague, 14059, Czechia
Investigator Site 62-009
Prague, 16902, Czechia
Investigator Site 62-011
Slaný, 27401, Czechia
Investigator Site 62-016
Uherské Hradiště, 68601, Czechia
Investigator Site 32-010
Bordeaux, 33075, France
Investigator Site 32-002
La Tronche, 38700, France
Investigator Site 32-014
Lille, 59000, France
Investigator Site 32-020
Lyon, 76000, France
Investigator Site 32-005
Montpellier, 34295, France
Investigator Site 32-001
Nancy, 54500, France
Investigator Site 32-004
Paris, 75010, France
Investigator Site 32-008
Paris, 75013, France
Investigator Site 32-017
Paris, 75013, France
Investigator Site 32-007
Paris, 75018, France
Investigator Site 32-003
Pau, 64000, France
Investigator Site 32-015
Poitiers, 86021, France
Investigator Site 32-013
Reims, 51092, France
Investigator Site 32-019
Rouen, 76031, France
Investigator Site 32-018
Saint-Brieuc, 22000, France
Investigator Site 32-006
Toulon, 83100, France
Investigator Site 32-012
Toulouse, 31400, France
Investigator Site 32-009
Tourcoing, 59200, France
Investigator Site 32-011
Valenciennes, 59300, France
Investigator Site 32-016
Valenciennes, 59300, France
Investigator Site 63-012
Batumi, 6004, Georgia
Investigator Site 63-007
Tbilisi, 0102, Georgia
Investigator Site 63-011
Tbilisi, 0112, Georgia
Investigator Site 63-004
Tbilisi, 0131, Georgia
Investigator Site 63-002
Tbilisi, 0159, Georgia
Investigator Site 63-006
Tbilisi, 0159, Georgia
Investigator Site 63-008
Tbilisi, 0159, Georgia
Investigator Site 63-010
Tbilisi, 0159, Georgia
Investigator Site 63-003
Tbilisi, 0167, Georgia
Investigator Site 63-009
Tbilisi, 0172, Georgia
Investigator Site 63-001
Tbilisi, 0180, Georgia
Investigator Site 63-005
Tbilisi, 0186, Georgia
Investigator Site 33-011
Coburg, Bavarian, 96450, Germany
Investigator Site 33-008
Greifswald, Mecklenburg-Vorpommern, 17475, Germany
Investigator Site 33-006
Homburg, Saarland, D-66421, Germany
Investigator Site 33-023
Bad Oeynhausen, 32545, Germany
Investigator Site 33-020
Berlin, 10789, Germany
Investigator Site 33-013
Berlin, 12559, Germany
Investigator Site 33-015
Bielefeld, 33604, Germany
Investigator Site 33-016
Bremen, 28277, Germany
Investigator Site 33-004
Erfurt, 99097, Germany
Investigator Site 33-001
Essen, 45138, Germany
Investigator Site 33-019
Frankfurt, 60590, Germany
Investigator Site 33-007
Frankfurt, 65929, Germany
Investigator Site 33-018
Giessen, 35392, Germany
Investigator Site 33-002
Halle, 06120, Germany
Investigator Site 33-005
Hamburg, 20246, Germany
Investigator Site 33-022
Hanover, 30625, Germany
Investigator Site 33-012
Heilbronn, 74177, Germany
Investigator Site 33-017
Kiel, 24105, Germany
Investigator Site 33-021
Leipzig, 04103, Germany
Investigator Site 33-010
Leverkusen, 51375, Germany
Investigator Site 33-024
Minden, 32429, Germany
Investigator Site 33-014
Nuremberg, 90402, Germany
Investigator Site 33-003
Würzburg, 97078, Germany
Investigator Site 64-010
Budapest, 1096, Hungary
Investigator Site 64-002
Budapest, 1097, Hungary
Investigator Site 64-006
Budapest, 1122, Hungary
Investigator Site 64-009
Budapest, 1134, Hungary
Investigator Site 64-001
Kecskemét, 6000, Hungary
Investigator Site 64-007
Kistarcsa, 2143, Hungary
Investigator Site 64-005
Nyíregyháza, 4400, Hungary
Investigator Site 35-008
Ashkelon, 78278, Israel
Investigator Site 35-009
Be’er Ya‘aqov, 6093000, Israel
Investigator Site 35-003
Hadera, 3810101, Israel
Investigator Site 35-006
Haifa, 3109601, Israel
Investigator Site 35-007
Haifa, 3109601, Israel
Investigator Site 35-002
Holon, 98100, Israel
Investigator Site 35-005
Jerusalem, 9103102, Israel
Investigator Site 35-014
Jerusalem, 91120, Israel
Investigator Site 35-001
Jerusalem, 91240, Israel
Investigator Site 35-010
Nahariya, 2210001, Israel
Investigator Site 35-011
Petah Tikva, 4941492, Israel
Investigator Site 35-013
Ramat Gan, 5265601, Israel
Investigator Site 35-012
Safed, 13100, Israel
Investigator Site 35-016
Tiberias, 1520800, Israel
Investigator Site 34-005
Ancona, Italy
Investigator Site 34-002
Bergamo, 24127, Italy
Investigator Site 34-007
Brescia, 25123, Italy
Investigator Site 34-001
Caserta, 81100, Italy
Investigator Site 34-009
Cona, 44120, Italy
Investigator Site 34-014
Foggia, 71100, Italy
Investigator Site 34-010
Genova, 16132, Italy
Investigator Site 34-004
Milan, 20138, Italy
Investigator Site 34-012
Piacenza, 29121, Italy
Investigator Site 34-003
Roma, 00163, Italy
Investigator Site 34-013
San Bonifacio, 37047, Italy
Investigator Site 23-012
Guadalajara, Jalisco, 44100, Mexico
Investigator Site 23-004
Guadalajara, Jalisco, 44657, Mexico
Investigator Site 23-007
Cuauhtémoc, Mexico City, 06090, Mexico
Investigator Site 23-005
Gustavo Adolfo Madero, Mexico City, 07020, Mexico
Investigator Site 23-010
San Pedro Garza García, Nuevo Léon, 66278, Mexico
Investigator Site 23-011
Oaxaca City, Oaxaca, 6800, Mexico
Investigator Site 23-001
Querétaro City, Querétaro, 76000, Mexico
Investigator Site 23-002
Culiacán, Sinaloa, 80230, Mexico
Investigator Site 23-006
Xalapa, Veracruz, 91193, Mexico
Investigator Site 36-003
Rotterdam, South Holland, 3000, Netherlands
Investigator Site 36-002
's-Hertogenbosch, 5223GZ, Netherlands
Investigator Site 36-012
Amstelveen, 1186AM, Netherlands
Investigator Site 36-006
Blaricum, 1261 AN, Netherlands
Investigator Site 36-009
Dirksland, 3247BW, Netherlands
Investigator Site 36-015
Dordrecht, 3318 AT, Netherlands
Investigator Site 36-007
Ede, 6716 RP, Netherlands
Investigator Site 36-001
Groningen, 9713 GZ, Netherlands
Investigator Site 36-013
Helmond, 5707HA, Netherlands
Investigator Site 36-014
Hoorn, 1624 NP, Netherlands
Investigator Site 36-010
Schiedam, 3118 JH, Netherlands
Investigator Site 36-004
Tilburg, 5042 AD, Netherlands
Investigator Site 36-011
Utrecht, 3582 KE, Netherlands
Investigator Site 65-007
Bialystok, 15-276, Poland
Investigator Site 65-014
Katowice, 40-156, Poland
Investigator Site 65-012
Kędzierzyn-Koźle, 47-200, Poland
Investigator Site 65-001
Lodz, 90-549, Poland
Investigator Site 65-018
Lodz, 93-513, Poland
Investigator Site 65-019
Olsztyn, 10-010, Poland
Investigator Site 65-015
Ostrowiec Świętokrzyski, 27-400, Poland
Investigator Site 65-021
Pomorskie, 81-717, Poland
Investigator Site 65-003
Poznan, 61-485, Poland
Investigator Site 65-020
Poznan, 61-848, Poland
Investigator Site 65-008
Rzeszów, 35-055, Poland
Investigator Site 65-010
Wroclaw, 50-556, Poland
Investigator Site 65-005
Wroclaw, 51-162, Poland
Investigator Site 65-011
Zgierz, 95-100, Poland
Investigator Site 66-014
Izhevsk, Udmurt Republic, 426063, Russia
Investigator Site 66-008
Chelyabinsk, 454136, Russia
Investigator Site 66-016
Kazan', 420033, Russia
Investigator Site 66-010
Kemerovo, 650002, Russia
Investigator Site 66-015
Moscow, 111539, Russia
Investigator Site 66-004
Moscow, 119192, Russia
Investigator Site 66-011
Moscow, 119192, Russia
Investigator Site 66-017
Moscow, 124489, Russia
Investigator Site 66-002
Novosibirsk, 63008, Russia
Investigator Site 66-005
Penza, 440026, Russia
Investigator Site 66-007
Perm, 614097, Russia
Investigator Site 66-012
Petrozavodsk, 185019, Russia
Investigator Site 66-018
Ryazan, 390039, Russia
Investigator Site 66-013
Saint Petersburg, 198205, Russia
Investigator Site 66-003
Saint Petersburg, 199106, Russia
Investigator Site 66-009
Tver', 170036, Russia
Investigator Site 66-001
Yekaterinburg, 620109, Russia
Investigator Site 67-010
Belgrade, 11000, Serbia
Investigator Site 67-002
Belgrade, 11040, Serbia
Investigator Site 67-004
Belgrade, 11050, Serbia
Investigator Site 67-008
Belgrade, 11080, Serbia
Investigator Site 67-001
Kamenitz, 21204, Serbia
Investigator Site 67-005
Niš, 18000, Serbia
Investigator Site 67-007
Niška Banja, 18205, Serbia
Investigator Site 67-003
Šabac, 15000, Serbia
Investigator Site 37-014
Palma de Mallorca, Balearic Islands, 07120, Spain
Investigator Site 37-010
Castellon, Castellon, 12004, Spain
Investigator Site 37-003
Barcelona, Catalonia, 08003, Spain
Investigator Site 37-005
Santiago de Compostela, La Coruña, 015706, Spain
Investigator Site 37-011
Majadahonda, Madrid, 28222, Spain
Investigator Site 37-024
Marbella, Malaga, 029603, Spain
Investigator Site 37-016
San Cristóbal de La Laguna, Tenerife, 038320, Spain
Investigator Site 37-001
Manises, Valencia, 46940, Spain
Investigator Site 37-025
A Coruña, Spain
Investigator Site 37-012
Alicante, 03010, Spain
Investigator Site 37-015
Badalona, 08916, Spain
Investigator Site 37-007
Barcelona, 08041, Spain
Investigator Site 37-002
Barcelona, 08907, Spain
Investigator Site 37-018
Huelva, 021005, Spain
Investigator Site 37-023
Lleida, 25198, Spain
Investigator Site 37-004
Madrid, 028007, Spain
Investigator Site 37-006
Madrid, 028041, Spain
Investigator Site 37-021
Madrid, 28006, Spain
Investigator Site 37-020
Madrid, 28034, Spain
Investigator Site 37-026
Madrid, 28040, Spain
Investigator Site 37-017
Málaga, 29010, Spain
Investigator Site 37-022
Murcia, 300008, Spain
Investigator Site 37-013
Seville, 041007, Spain
Investigator Site 37-009
Valencia, 046020, Spain
Investigator Site 37-008
Valencia, 4610, Spain
Investigator Site 68-008
Kharkiv, Novobavarskiy, 61157, Ukraine
Investigator Site 68-017
Dnipro, 49027, Ukraine
Investigator Site 68-009
Ivano-Frankivsk, 76008, Ukraine
Investigator Site 68-005
Ivano-Frankivsk, 76018, Ukraine
Investigator Site 68-001
Kharkiv, 61039, Ukraine
Investigator Site 68-011
Kharkiv, 61058, Ukraine
Investigator Site 68-010
Kharkiv, 61103, Ukraine
Investigator Site 68-002
Kharkiv, 61176, Ukraine
Investigator Site 68-012
Kyiv, 01601, Ukraine
Investigator Site 68-003
Kyiv, 0200, Ukraine
Investigator Site 68-015
Kyiv, 02166, Ukraine
Investigator Site 68-013
Kyiv, 03110, Ukraine
Investigator Site 68-007
Kyiv, 04050, Ukraine
Investigator Site 68-006
Lviv, 79013, Ukraine
Investigator Site 68-014
Vinnytsia, 21000, Ukraine
Investigator Site 68-016
Zaporizhzhya, 69106, Ukraine
Investigator Site 68-004
Zhytomyr, 10002, Ukraine
Investigator Site 39-012
Harlow, Essex, CM2 01QX, United Kingdom
Investigator Site 39-003
Scunthorpe, North Lincolshire, DN15 7BH, United Kingdom
Investigator Site 39-005
Dudley, West Midlands, DY1 2HQ, United Kingdom
Investigator Site 39-009
Barnsley, S75 2EP, United Kingdom
Investigator Site 39-016
High Wycombe, HP11 2TT, United Kingdom
Investigator Site 39-008
Inverness, IV2 3JH, United Kingdom
Investigator Site 39-011
Leicester, LE3 9QP, United Kingdom
Investigator Site 39-013
Liverpool, L9 7AL, United Kingdom
Investigator Site 39-015
London, SE5 9RS, United Kingdom
Investigator Site 39-010
North Shields, NE29 8NH, United Kingdom
Investigator Site 39-007
Swansea, SA6 6NL, United Kingdom
Investigator Site 39-004
York, YO31 8HE, United Kingdom
Related Publications (3)
Coats AJS, Anker SD, Lund LH, Filippatos G, Rossignol P, Pitt B, Weir MR, Kosiborod MN, Metra M, Bohm M, Ezekowitz JA, Bayes-Genis A, Mentz RJ, Ponikowski P, Senni M, Cleland JGF, Goudev A, Khintibidze I, Lindenfeld J, Merkely B, Waechter S, Budden J, Perrin A, Butler J. Patiromer for Heart Failure Medication Optimization in Patients With Current or Past Hyperkalemia: DIAMOND Subanalysis. JACC Heart Fail. 2024 Dec;12(12):2026-2037. doi: 10.1016/j.jchf.2024.08.003. Epub 2024 Sep 25.
PMID: 39340493DERIVEDButler J, Anker SD, Lund LH, Coats AJS, Filippatos G, Siddiqi TJ, Friede T, Fabien V, Kosiborod M, Metra M, Pina IL, Pinto F, Rossignol P, van der Meer P, Bahit C, Belohlavek J, Bohm M, Brugts JJ, Cleland JGF, Ezekowitz J, Bayes-Genis A, Gotsman I, Goudev A, Khintibidze I, Lindenfeld J, Mentz RJ, Merkely B, Montes EC, Mullens W, Nicolau JC, Parkhomenko A, Ponikowski P, Seferovic PM, Senni M, Shlyakhto E, Cohen-Solal A, Szecsody P, Jensen K, Dorigotti F, Weir MR, Pitt B. Patiromer for the management of hyperkalemia in heart failure with reduced ejection fraction: the DIAMOND trial. Eur Heart J. 2022 Nov 1;43(41):4362-4373. doi: 10.1093/eurheartj/ehac401.
PMID: 35900838DERIVEDBolanos JA, Seliger SL. Recurrent Hyperkalemia in Renin-Angiotensin-Aldosterone System Inhibitor (RAASi) Treatment: Stuck between a Rock and a Hard Place. Clin J Am Soc Nephrol. 2021 Mar 8;16(3):345-347. doi: 10.2215/CJN.00950121. Epub 2021 Feb 19. No abstract available.
PMID: 33608263DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- DIAMOND Clinical Study Team
- Organization
- Vifor Pharma, Inc.
Study Officials
- STUDY DIRECTOR
Peter Szecsödy, MD
Vifor Pharma
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2019
First Posted
March 25, 2019
Study Start
April 24, 2019
Primary Completion
September 2, 2021
Study Completion
September 2, 2021
Last Updated
February 24, 2023
Results First Posted
February 24, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be requested 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting
- Access Criteria
- A research proposal must be approved by an independent review panel and the study sponsor and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.