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WORLD HEART FEDERATION (WHF) COVID-19 and Cardiovascular Disease Survey (WHF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04475471
Recruitment Status : Recruiting
First Posted : July 17, 2020
Last Update Posted : September 7, 2020
Sponsor:
Collaborators:
Centre for Chronic Disease Control, India
University of Cape Town
World Heart Federation, Geneva, Switzerland
Information provided by (Responsible Party):
Dorairaj Prabhakaran, Public Health Foundation of India

Tracking Information
First Submitted Date July 1, 2020
First Posted Date July 17, 2020
Last Update Posted Date September 7, 2020
Actual Study Start Date June 11, 2020
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 16, 2020)
  • Assessment of the patients for major adverse cardiovascular events (MACE) [ Time Frame: Outcome will be assessed at discharge and 30-day follow-up visit from the hospital admission date. ]
    MACE is defined as the presence of any of the following CVD conditions: myocarditis, arrhythmia, heart failure [including Left ventricular ejection fraction], acute coronary event, as per the hospital admission and discharge records. Data will be collected at each site by local investigators and sent to the coordinating center. Only data outlined on the entry and outcome forms will be collected.
  • Assessment of the patients for Pulmonary outcomes including Pulmonary embolism, pneumonia, acute respiratory distress syndrome, need of intensive care - number of days in ICU or ICCU, need of ventilator] [ Time Frame: at discharge and 30-day follow-up visits from the hospital admission date. ]
    Data will be collected at each site by local investigators and sent to the coordinating center. Only data outlined on the entry and outcome forms will be collected.
  • Assessment of the patients for Neurological Outcomes including stroke and Transient Ischemic Attack (TIA) [ Time Frame: at discharge and 30-day follow-up visits from the hospital admission date. ]
    Data will be collected at each site by local investigators and sent to the coordinating center. Only data outlined on the entry and outcome forms will be collected.
  • All cause deaths [ Time Frame: any time during the hospital admission and at 30-day follow-up. ]
    Specific causes of death to be evaluated using CRF including sudden cardiac death, death due to Myocardial infarction, Death due to heart failure, death due to stroke
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title WORLD HEART FEDERATION (WHF) COVID-19 and Cardiovascular Disease Survey
Official Title WHF COVID-19 and Cardiovascular Disease Survey
Brief Summary A global study for a better understanding of the cardiovascular conditions that increase the risk of developing severe COVID-19, and a better characterization of cardiovascular complications in hospitalized patients with COVID-19.
Detailed Description

COVID-19 may be cardiotropic in a subset of patients. Both acute and pre-existing CVD impact outcomes unfavorably. It is possible that one common CVD treatment, medications that impact ACE-2 function, may impact outcomes either favorably or unfavorably.

However, studies so far have, perforce, been conducted with important limitations (e.g. small numbers, limited geographical representation, lack of data standardization for risk factors and outcomes, limited measurement, lack of appropriate adjustment for important confounders, and missing data). Considering the high global prevalence of CVD and its risk factors (e.g. hypertension and diabetes) and the suggested link with COVID19 it is urgent to initiate more robust studies to clarify the many issues early reports have engendered. So that investigators will conduct a global study for a better understanding of the cardiovascular conditions that increase the risk of developing severe COVID-19, and a better characterization of cardiovascular complications in hospitalized patients with COVID-19.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Participants will be recruited in any hospital where COVID19 patients are hospitalized. Investigators will invite all WHF members from 100+ countries to identify at least two recruiting centres in their respective countries. Each centre should recruit between 50 and 200 consecutive patients. There is no limit in the number of sites to take part.
Condition
  • COVID-19
  • Cardiovascular Diseases
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 16, 2020)
5200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All adults (as locally defined) with confirmed COVID-19 infection who are hospitalized are eligible.

Exclusion Criteria:

  • Patients for whom investigators are unable to obtain informed consent will be excluded.
  • Patients who are unlikely to stay in the recruiting centre for 30 days (i.e. likely to be transferred)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: KAVITA SINGH, PhD 9899691150 ext 91 kavita@ccdcindia.org
Contact: DORAIRAJ PRABHAKARAN, MD, DM 124-4781400 ext 91 dprabhakaran@phfi.org
Listed Location Countries Argentina,   Bosnia and Herzegovina,   Ghana,   India,   Iran, Islamic Republic of,   Sudan
Removed Location Countries  
 
Administrative Information
NCT Number NCT04475471
Other Study ID Numbers RA1413
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description:

Below is the detail of the data to be collected from each patient enrolled in the study:

  • Patient demographics: age, sex, ethnicity, weight/height and education level
  • Clinical history: smoking status, hypertension, diabetes, obesity, heart failure, rheumatic heart disease, chagas, history of Coronary artery disease/ Percutaneous Coronary Interventions/ Coronary artery bypass graft surgery
  • Usual medication (before hospitalization)
  • Clinical characteristics at presentation: confirmed diagnosis of COVID-19, heart rate, blood pressure
  • Tests: ECG, ECHO, troponin, NT-proBNP and other biochemical markers
  • Medication received during hospitalization: cardiovascular and non-cardiovascular medications.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Analytic Code
Time Frame: Two years after study completion and publication of main study results i.e., Dec 2023
Access Criteria: Two years after study completion and publication of main study results i.e., Dec 2023, and upon request from external researchers being sent to the study PIs and study steering committee for review and approval
URL: https://www.world-heart-federation.org/
Responsible Party Dorairaj Prabhakaran, Public Health Foundation of India
Study Sponsor Public Health Foundation of India
Collaborators
  • Centre for Chronic Disease Control, India
  • University of Cape Town
  • World Heart Federation, Geneva, Switzerland
Investigators
Principal Investigator: KAREN SILWA, MD, PhD University of Cape Town
Principal Investigator: Pablo PEREL, MD, PhD London School of Hygiene and Tropical Medicine
PRS Account Public Health Foundation of India
Verification Date September 2020