A Survey to Assess Effects of Covid-19 on Cardiovascular Patients
1 other identifier
observational
76
1 country
1
Brief Summary
The design included 152 patients with confirmed heart failure (HF) evaluated in two different periods of time: a baseline before the outbreak, and other during the outbreak of which 76 patients were randomized in each group. A care and follow-up guide was used as an instrument through a face-to-face survey (baseline group) and telemedicine (group outbreak). The primary outcome was the comparison of functional class modification observed in patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2019
Typical duration for all trials
1 active site
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
Study Start
First participant enrolled
May 15, 2019
CompletedFirst Submitted
Initial submission to the registry
August 7, 2020
CompletedFirst Posted
Study publicly available on registry
August 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2021
CompletedAugust 11, 2020
August 1, 2020
2.1 years
August 7, 2020
August 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
NYHA class deterioration
NYHA class modification in the last four weeks. Basal and follow-up measures: Basal on June 2020. Follow up: every three months and a year (June 2021). NYHA Scale: Minimum: 1 to maximum :4
1 year
Secondary Outcomes (4)
Dyspnea deterioration
1 year
Paroxysmal nocturnal dyspnea deterioration
1 year
Edema
1 year
Daily activities In the last four weeks? Please, mention if you a perceived limitation on : Walking deterioration
1 year
Study Arms (2)
Basal
All adults (age \>18 years), both gender, Heart failure patients (european society of cardiology ) criteria, sign consent. A survey to access information about symptomatology, treatment, and medical care in period may 15 to june 15, 2019 ( without covid-19 )
Ourbreak
All adults (age \>18 years), both gender, Heart failure patients (european society of cardiology ) criteria, sign consent. A survey to access information about symptomatology, treatment, and medical care in period may 15 to june 15, 2020 ( ongoing covid-19 )
Interventions
Interventions were recorded in two groups of patients, who were randomly selected, in two different periods of time. The basal group was intervened from 15 May to 15 June 2019, a pandemic-free period. The outbreak group from 15 May to 15 June 2020, corresponding to increased activity of contagiousness and mortality associated with COVID-19, in general population in Mexico14 Basal measurement was performed in a face to face method. In Outbreak period, under social isolation conditions, patients were evaluated by telephone. The assessments were performed out by medical staff with specialized training, with evaluations to which patients were accustomed by regular cohort assessments. The questions were ordered and systematized in a patient evaluation, care, and follow-up guide (appendix). A causality association question of emotional distress perception was added. We recorded mortality and rehospitalization
Eligibility Criteria
All HF outpatients belonged to an open follow-up cohort of the HF clinic of the National Institute of Cardiology of Mexico, which started enrollment since September 2016.
You may qualify if:
- confirmed diagnosis of HF, according with the ESC guidelines criteria
- both genders,
- above 18 years,
- agreed to participate
You may not qualify if:
- Impediment to contacting patients
- marked physical impairment
- cognitive impairment that prevents optimal interrogation
- Cultural barriers involving communication limitation (languages, dialects, reading and writing)
- Patient doesn't want to participate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro de Insuficiencia Cardiaca Instituto Nacional de Cardiologia
Mexico City, 14080, Mexico
Related Publications (7)
Cowie MR, Mosterd A, Wood DA, Deckers JW, Poole-Wilson PA, Sutton GC, Grobbee DE. The epidemiology of heart failure. Eur Heart J. 1997 Feb;18(2):208-25. doi: 10.1093/oxfordjournals.eurheartj.a015223. No abstract available.
PMID: 9043837BACKGROUNDGo AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):e28-e292. doi: 10.1161/01.cir.0000441139.02102.80. Epub 2013 Dec 18. No abstract available.
PMID: 24352519BACKGROUNDPonikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.
PMID: 27206819BACKGROUNDHawkins NM, Jhund PS, McMurray JJ, Capewell S. Heart failure and socioeconomic status: accumulating evidence of inequality. Eur J Heart Fail. 2012 Feb;14(2):138-46. doi: 10.1093/eurjhf/hfr168.
PMID: 22253454BACKGROUNDYang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.
PMID: 32105632BACKGROUNDInciardi RM, Lupi L, Zaccone G, Italia L, Raffo M, Tomasoni D, Cani DS, Cerini M, Farina D, Gavazzi E, Maroldi R, Adamo M, Ammirati E, Sinagra G, Lombardi CM, Metra M. Cardiac Involvement in a Patient With Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Jul 1;5(7):819-824. doi: 10.1001/jamacardio.2020.1096.
PMID: 32219357BACKGROUNDAnderson JL, Heidenreich PA, Barnett PG, Creager MA, Fonarow GC, Gibbons RJ, Halperin JL, Hlatky MA, Jacobs AK, Mark DB, Masoudi FA, Peterson ED, Shaw LJ. ACC/AHA statement on cost/value methodology in clinical practice guidelines and performance measures: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures and Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jun 3;63(21):2304-22. doi: 10.1016/j.jacc.2014.03.016. Epub 2014 Mar 27. No abstract available.
PMID: 24681044RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
EDUARDO CHUQUIURE-VALENZUELA, MD
Centro en insuficiencia cardiaca
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 18 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
August 7, 2020
First Posted
August 11, 2020
Study Start
May 15, 2019
Primary Completion
June 15, 2021
Study Completion
July 15, 2021
Last Updated
August 11, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- august 1, 2021 to december 30,2021
- Access Criteria
- open access
IPD PLAN Eduardo Chuquiure-Valenzuela is Principal investigator, conceptual protocol designer, performed statistics, write manuscript and draft corrections. Alan Fuentes-Mendoza, Emmanuel Tapia-López, Daniel García-Romero Elyz Cortez-Lopez and Alejandra Marin-Sanchez, collaborate in clinical, research and analysis activities for CENTRO EN INSUFICIENCIA CARDIACA, Also, they assist in telephone interviews, writing of the manuscript. performed and checked statistics, co- writer, and draft corrections. Laura Rodríguez Chávez, Nilda Espíndola Zavaleta, Gerardo Vieyra Herrera, and Enrique Lopez Mora, are affiliated cardiologists, who participate in the draft revision for publication.