NCT03387813

Brief Summary

The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for future HF events or mortality.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,358

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable heart-failure

Geographic Reach
2 countries

129 active sites

Status
completed

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

December 12, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 2, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 15, 2018

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2023

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

August 7, 2025

Completed
Last Updated

August 7, 2025

Status Verified

July 1, 2025

Enrollment Period

5.2 years

First QC Date

December 12, 2017

Results QC Date

January 30, 2025

Last Update Submit

July 18, 2025

Conditions

Keywords

Heart FailureHemodynamic MonitoringCardioMEMSPulmonary Artery Pressure

Outcome Measures

Primary Outcomes (8)

  • (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality

    The composite of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP) 3. The number of deaths of any cause added together with equal weighting into a total number of events

    12 months post-implantation (395 days after implant date)

  • (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis]

    The composite of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP) 3. The number of deaths of any cause added together with equal weighting into a total number of events.

    The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months).

  • (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]

    The composite of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP) 3. The number of deaths of any cause added together with equal weighting into a total number of events.

    12 Months Post Implantation

  • (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]

    The composite of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP) 3. The number of deaths of any cause added together with equal weighting into a total number of events.

    12 Months Post-Implantation

  • (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality

    The composite outcome of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy 3. The number of deaths of any cause added together with equal weighting into a total number of events

    12 months post-implantation (395 days after implant date)

  • (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis]

    The composite outcome of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy 3. The number of deaths of any cause added together with equal weighting into a total number of events

    Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months).

  • (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]

    The composite outcome of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy 3. The number of deaths of any cause added together with equal weighting into a total number of events

    12 Months Post Implantation

  • (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]

    The composite outcome of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy 3. The number of deaths of any cause added together with equal weighting into a total number of events

    12 Months Post Implantation

Secondary Outcomes (43)

  • (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits

    12 months post-implantation

  • (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis)

    The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months).

  • (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis)

    12 Months Post Implantation

  • (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis)

    12 Months Post Implantation

  • (Randomized Arm) HFHs

    12 months post-implantation

  • +38 more secondary outcomes

Other Outcomes (27)

  • (Randomized Arm) Cardiovascular Mortality

    12 months post-implantation

  • (Randomized Arm) All-cause Hospitalizations

    12 months post-implantation

  • (Randomized Arm) Frequency of Subject PA Pressure Uploads

    12 months post-implantation

  • +24 more other outcomes

Study Arms (3)

Randomized Arm - Treatment Group

EXPERIMENTAL

Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.

Device: CardioMEMS™ HF System

Randomized Arm - Control Group

EXPERIMENTAL

Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.

Device: CardioMEMS™ HF System

Single Arm

EXPERIMENTAL

Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.

Device: CardioMEMS™ HF System

Interventions

The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.

Also known as: CardioMEMS, CardioMEMS PA Sensor, CardioMEMS HF System
Randomized Arm - Control GroupRandomized Arm - Treatment GroupSingle Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis and treatment for heart failure (HF) (regardless of left ventricular ejection fraction (LVEF)) for \> 90 days prior to the date of consent:
  • a. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current American Heart Association (AHA)/American College of Cardiology (ACC) guidelines as standard-of-care for HF therapy in the United States, with any intolerance documented.
  • GUIDE-HF Randomized Arm Only: NYHA Class II, III or IV HF symptoms documented within 30 days prior to consent.
  • GUIDE-HF Single Arm Only: NYHA Class III HF symptoms documented within 30 days prior to consent.
  • HF hospitalization (HFH) within 12 months prior to consent and/or elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or Brain Natriuretic Peptide (BNP)) within 30 days prior to consent defined as:
  • Subjects with LVEF ≤ 40%: NT-proBNP ≥ 1000 pg/mL (or BNP ≥ 250 pg/mL).
  • Subjects with LVEF \> 40%: NT-proBNP ≥ 700 pg/mL (or BNP ≥ 175 pg/mL).
  • Thresholds for NT-proBNP and BNP (for both LVEF ≤ 40% and LVEF \> 40%) will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2
  • ≥ 18 years of age
  • Chest circumference of \< 65 inches, if BMI is \> 35 kg/m2
  • Written informed consent obtained from subject
  • Willing and able to upload pulmonary artery (PA) pressure information and comply with the follow-up requirements

You may not qualify if:

  • Intolerance to all neuro-hormonal antagonists (i.e., intolerance to angiotensin converting enzyme-inhibitors (ACE-I), angiotensin receptor blockers (ARB), angiotensin-neprilysin inhibitors (ARNi), hydralazine/isosorbide dinitrate and beta-blockers)
  • ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes)
  • Received or are likely to receive an advanced therapy (e.g., mechanical circulatory support or cardiac transplant) in the next 12 months
  • NYHA Class IV HF patients with:
  • Continuous or chronic use of scheduled intermittent inotropic therapy for HF and an INTERMACS level of ≤ 4, OR
  • Persistence of fluid overload with maximum (or dose equivalent) diuretic intervention
  • Glomerular Filtration Rate (eGFR) \< 25 mL/min and non-responsive to diuretic therapy, or receiving chronic dialysis
  • Inability to tolerate or receive dual antiplatelet therapy or anticoagulation therapy for one month post-implantation
  • Significant congenital heart disease that has not been repaired and would prevent implantation of the CardioMEMS™ PA Sensor
  • Implanted with mechanical right heart valve(s)
  • Unrepaired severe valvular disease
  • Pregnant or planning to become pregnant in the next 12 months
  • An active, ongoing infection, defined as being febrile, an elevated white blood cell count, on intravenous antibiotics, and/or positive cultures (blood, sputum or urine).
  • History of current or recurrent (≥ 2 episodes within 5 years prior to consent) pulmonary emboli and/or deep vein thrombosis
  • Major cardiovascular event (e.g., unstable angina, myocardial infarction, percutaneous coronary intervention, open heart surgery, or stroke, etc.) within 90 days prior to consent
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (129)

Banner-University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Arizona Cardiovascular Research Center

Phoenix, Arizona, 85016, United States

Location

Phoenix Cardiovascular Research Group

Phoenix, Arizona, 85018, United States

Location

University of Arizona

Tucson, Arizona, 85719, United States

Location

Washington Regional Medical Center

Fayetteville, Arkansas, 72703, United States

Location

Baptist Health Medical Center

Little Rock, Arkansas, 72205, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

John Muir Medical Center

Concord, California, 94520, United States

Location

Adventist Health St. Helena

Deer Park, California, 94574, United States

Location

Scripps Health

La Jolla, California, 92037, United States

Location

University of California at San Diego (UCSD) Medical Center

La Jolla, California, 92037, United States

Location

USC University Hospital

Los Angeles, California, 90033, United States

Location

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Eisenhower Medical Center

Rancho Mirage, California, 92270, United States

Location

Sutter Medical Center, Sacramento

Sacramento, California, 95816, United States

Location

Mercy Medical Group - Cardiology

Sacramento, California, 95819, United States

Location

San Diego Cardiac Center

San Diego, California, 92123, United States

Location

California Pacific Medical Center - Van Ness Campus

San Francisco, California, 94109, United States

Location

Ventura Cardiology Consultants

Ventura, California, 93003, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

North Colorado Medical Center

Greeley, Colorado, 80631, United States

Location

South Denver Cardiology Associates PC

Littleton, Colorado, 80120, United States

Location

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

Location

Bethesda Memorial Hospital

Boynton Beach, Florida, 33466, United States

Location

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

Memorial Regional Hospital

Hollywood, Florida, 33020, United States

Location

First Coast Cardiovascular Institute

Jacksonville, Florida, 32216, United States

Location

Memorial Hospital Jacksonville

Jacksonville, Florida, 32216, United States

Location

Advent Health Orlando

Orlando, Florida, 32803, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Piedmont Athens Regional Medical Center

Athens, Georgia, 30606, United States

Location

University Hospital

Augusta, Georgia, 30901, United States

Location

WellStar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

Northshore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Advocate Health and Hospitals Corporation

Oakbrook Terrace, Illinois, 60181, United States

Location

St. Vincent Hospital

Indianapolis, Indiana, 46240, United States

Location

Heart Center of Lake County

Merrillville, Indiana, 46410, United States

Location

Iowa Heart Center

West Des Moines, Iowa, 50266, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Cardiovascular Research Institute of Kansas

Wichita, Kansas, 67226, United States

Location

Our Lady of the Lake Hospital

Baton Rouge, Louisiana, 70808, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70361, United States

Location

Louisiana State University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Advanced Cardiovascular Specialists

Shreveport, Louisiana, 71105, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Massachusetts

Worcester, Massachusetts, 01655, United States

Location

University of Michigan

Ann Arbor, Michigan, 48104, United States

Location

McLaren Health Care Corporation

Auburn Hills, Michigan, 48326, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MidMichigan Medical Center-Midland

Midland, Michigan, 48640, United States

Location

Providence Hospital

Southfield, Michigan, 48075, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

University of Minnesota Medical Center Fairview

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

St. Cloud Hospital

Saint Cloud, Minnesota, 56303, United States

Location

St. Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

North Kansas City Hospital

North Kansas City, Missouri, 64116, United States

Location

Mercy Hospital St. Louis

St Louis, Missouri, 63141, United States

Location

BryanLGH Heart Institute

Lincoln, Nebraska, 68506, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Renown Regional Medical Center

Reno, Nevada, 89502, United States

Location

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Saint Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Lourdes Cardiology Services

Voorhees Township, New Jersey, 08043, United States

Location

New Mexico Heart Institute

Albuquerque, New Mexico, 87102, United States

Location

New York University Hospital

New York, New York, 10016, United States

Location

Mount Sinai Hospital

New York, New York, 10019, United States

Location

New York-Presbyterian/Columbia University

New York, New York, 10032, United States

Location

Hudson Valley Cardiovascular Practice, P.C.

Poughkeepsie, New York, 12601, United States

Location

Rochester General Hospital

Rochester, New York, 14621, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Vidant Medical Center

Greenville, North Carolina, 27835, United States

Location

NC Heart and Vascular Research

Raleigh, North Carolina, 27607, United States

Location

WakeMed Hospital

Raleigh, North Carolina, 27610, United States

Location

Akron City Hospital

Akron, Ohio, 44309, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

St. Elizabeth Health Center

Youngstown, Ohio, 44501, United States

Location

Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

Oklahoma Heart Hospital South

Oklahoma City, Oklahoma, 73135, United States

Location

Oklahoma Heart Institute at Utica

Tulsa, Oklahoma, 74133, United States

Location

Providence Heart and Vascular

Portland, Oregon, 97225, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Pinnacle Health System

Harrisburg, Pennsylvania, 17105, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17603, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

Allegheny General Hospital - ASRI

Pittsburgh, Pennsylvania, 15212, United States

Location

The Reading Hospital and Medical Center

West Reading, Pennsylvania, 19611, United States

Location

Main Line Health Center/Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Prisma Health-Midlands

Columbia, South Carolina, 29203, United States

Location

Greenville Health System

Greenville, South Carolina, 29605, United States

Location

Sanford USD Medical Center

Sioux Falls, South Dakota, 57117, United States

Location

Tennova Healthcare - Turkey Creek Medical Center

Knoxville, Tennessee, 37920, United States

Location

Methodist University Hospital

Memphis, Tennessee, 38104, United States

Location

St Thomas Hospital

Nashville, Tennessee, 37205, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Acension Texas Cardiovascular

Austin, Texas, 78705, United States

Location

Austin Heart

Austin, Texas, 78756, United States

Location

Baylor University Hospital

Dallas, Texas, 75246, United States

Location

John Peter Smith Hospital

Fort Worth, Texas, 76104, United States

Location

Park Plaza Hospital

Houston, Texas, 77004, United States

Location

CHI St. Luke's Health Baylor College of Medicine Med. Ctr.

Houston, Texas, 77030, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Methodist Healthcare System of San Antonio

San Antonio, Texas, 78229, United States

Location

Virginia Heart - The Cardiovascular Group, P.C.

Falls Church, Virginia, 22042, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Bon Secours Heart & Vascular Institute

Richmond, Virginia, 23226, United States

Location

Winchester Medical Center

Winchester, Virginia, 22601, United States

Location

Providence Everett Medical Center

Everett, Washington, 98206, United States

Location

Swedish Medical Center - Heart & Vascular

Seattle, Washington, 98122, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Aurora Medical Group

Milwaukee, Wisconsin, 53215, United States

Location

Waukesha Memorial Hospital

Waukesha, Wisconsin, 53188, United States

Location

Aspirus Wausau Hospital

Wausau, Wisconsin, 54401, United States

Location

Foothills Medical Centre

Calgary, Alberta, T2N2T9, Canada

Location

Vancouver General Hospital (U of BC)

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P9, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (5)

  • Zile MR, Abraham WT, Stevenson LW, Costanzo MR, Angermann CE, Mehra MR, Desai AS, Ducharme A, Johnson N, Henderson J, Lindenfeld J. Relationship Between Remote, Ambulatory Pulmonary Artery Pressures, and All-Cause Mortality in Patients With Chronic Heart Failure. Circ Heart Fail. 2025 Jun;18(6):e012754. doi: 10.1161/CIRCHEARTFAILURE.124.012754. Epub 2025 Apr 14.

  • Desai AS, Maisel A, Mehra MR, Zile MR, Ducharme A, Paul S, Sears SF, Smart F, Bhatt K, Krim S, Henderson J, Johnson N, Adamson PB, Costanzo MR, Lindenfeld J; GUIDE-HF Investigators. Hemodynamic-Guided Heart Failure Management in Patients With Either Prior HF Hospitalization or Elevated Natriuretic Peptides. JACC Heart Fail. 2023 Jun;11(6):691-698. doi: 10.1016/j.jchf.2023.01.007. Epub 2023 Apr 12.

  • Zile MR, Mehra MR, Ducharme A, Sears SF, Desai AS, Maisel A, Paul S, Smart F, Grafton G, Kumar S, Nossuli TO, Johnson N, Henderson J, Adamson PB, Costanzo MR, Lindenfeld J. Hemodynamically-Guided Management of Heart Failure Across the Ejection Fraction Spectrum: The GUIDE-HF Trial. JACC Heart Fail. 2022 Dec;10(12):931-944. doi: 10.1016/j.jchf.2022.08.012. Epub 2022 Oct 12.

  • Zile MR, Desai AS, Costanzo MR, Ducharme A, Maisel A, Mehra MR, Paul S, Sears SF, Smart F, Chien C, Guha A, Guichard JL, Hall S, Jonsson O, Johnson N, Sood P, Henderson J, Adamson PB, Lindenfeld J. The GUIDE-HF trial of pulmonary artery pressure monitoring in heart failure: impact of the COVID-19 pandemic. Eur Heart J. 2022 Jul 14;43(27):2603-2618. doi: 10.1093/eurheartj/ehac114.

  • Lindenfeld J, Zile MR, Desai AS, Bhatt K, Ducharme A, Horstmanshof D, Krim SR, Maisel A, Mehra MR, Paul S, Sears SF, Sauer AJ, Smart F, Zughaib M, Castaneda P, Kelly J, Johnson N, Sood P, Ginn G, Henderson J, Adamson PB, Costanzo MR. Haemodynamic-guided management of heart failure (GUIDE-HF): a randomised controlled trial. Lancet. 2021 Sep 11;398(10304):991-1001. doi: 10.1016/S0140-6736(21)01754-2. Epub 2021 Aug 27.

MeSH Terms

Conditions

Heart FailureHeart Failure, SystolicHeart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Limitations and Caveats

The COVID-19 pandemic affected the GUIDE-HF Randomized Arm study. The impact of COVID-19 on the primary endpoint and components was addressed through sensitivity analyses. Single Arm Total Efficacy Population includes implanted subjects not belonging to a qualifying criteria group.

Results Point of Contact

Title
Fei San Lee, PhD, Sr Clinical Research Scientist
Organization
Abbott

Study Officials

  • Nessa Johnson, PhD

    Abbott

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2017

First Posted

January 2, 2018

Study Start

March 15, 2018

Primary Completion

May 17, 2023

Study Completion

May 17, 2023

Last Updated

August 7, 2025

Results First Posted

August 7, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations