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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 : January 27, 2023
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

Study Description
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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.

Condition or disease
COVID-19 Cardiovascular Diseases

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.

Given the continued increase in the COVID-19 cases worldwide, the study team launched WHF COVID-19 and CVD Extension Study to continue recruitment of the COVID-19 patients hospitalized in the selected high-income, middle-income, and low-income countries (sample size = 3300 patients). This extension study will provide valuable insights on the temporal trends in clinical characteristics of COVID-19, the specific cause of deaths such as sudden cardiac death and its relationship with COVID-19 infection, the impact of COVID-19 vaccination on the clinical outcomes at discharge and overall mortality, and anti-microbial resistance and its association with outcomes in COVID-19 patients.

Further, the study team is also conducting a WHF COVID-19 Long-term follow-up Study in a sample of 2000 patients from the WHF COVID-19 extension study that aims to determine the short- (3 month), medium- (6 month) and long-term (9-12 month) sequelae to COVID-19 including ongoing symptomatology, re-hospitalizations, mortality, impact on physical function and psycho-social consequences. The long-term sequelae of COVID-19 post hospital discharge are unknown, and the trajectories are likely to be heterogeneous across countries. This study will provide invaluable information about the intermediate to long-term effects of COVID-19 and the disease burden and economic impact of COVID-19 on patients with long term sequelae.

Sample Size:

  1. WHF COVID-19 and CVD Study (primary cohort): 5200 participants
  2. WHF Extension Study: 3300 participants
  3. WHF Long term follow-up Study: approx. 2200 participants
Study Design
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Study Type : Observational
Estimated Enrollment : 5200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: WHF COVID-19 and Cardiovascular Disease Survey
Actual Study Start Date : September 1, 2020
Actual Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. Impact of COVID-19 vaccination on clinical outcomes - MACE (major adverse cardiovascular events) in COVID-19 hospitalized patients. [ Time Frame: upto 30 days ]
    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.

  6. Persistence of long-COVID Symptoms at 1-month after discharge among survivors of COVID-19 hospitalizations. [ Time Frame: 1-month after hospital discharge ]
    Questionnaires will be administered telephonically at 1-month after hospital discharge. Data will be collected at each site by local investigators and sent to the coordinating center.

  7. Persistence of long-COVID Symptoms at 3-month after discharge among survivors of COVID-19 hospitalizations. [ Time Frame: 3-month after hospital discharge ]
    Questionnaires will be administered telephonically at 3-month after hospital discharge. Data will be collected at each site by local investigators and sent to the coordinating center.

  8. Persistence of long-COVID Symptoms at 6-month after discharge among survivors of COVID-19 hospitalizations. [ Time Frame: 6-month after hospital discharge ]
    Questionnaires will be administered telephonically at 6-month after hospital discharge. Data will be collected at each site by local investigators and sent to the coordinating center.

  9. Persistence of long-COVID Symptoms at 9-12-month after discharge among survivors of COVID-19 hospitalizations. [ Time Frame: 9-12-month after hospital discharge ]
    Questionnaires will be administered telephonically at 9-12-month after hospital discharge. Data will be collected at each site by local investigators and sent to the coordinating center.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04475471


Contacts
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Contact: KAVITA SINGH, PhD 9899691150 ext 91 kavita@ccdcindia.org
Contact: DORAIRAJ PRABHAKARAN, MD, DM 124-4781400 ext 91 dprabhakaran@phfi.org

Locations
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Sponsors and Collaborators
Public Health Foundation of India
Centre for Chronic Disease Control, India
University of Cape Town
World Heart Federation, Geneva, Switzerland
Investigators
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Principal Investigator: KAREN SILWA, MD, PhD University of Cape Town
Principal Investigator: Pablo PEREL, MD, PhD London School of Hygiene and Tropical Medicine
More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: Dorairaj Prabhakaran, Prof, Public Health Foundation of India
ClinicalTrials.gov Identifier: NCT04475471    
Other Study ID Numbers: RA1413
First Posted: July 17, 2020    Key Record Dates
Last Update Posted: January 27, 2023
Last Verified: January 2023
Individual Participant Data (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
Informed Consent Form (ICF)
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/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dorairaj Prabhakaran, Public Health Foundation of India:
SARS-CoV-2
Additional relevant MeSH terms:
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COVID-19
Cardiovascular Diseases
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases