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

January 25, 2023 updated by: Dorairaj Prabhakaran, Public Health Foundation of India

WHF COVID-19 and Cardiovascular Disease Survey

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Recruiting
        • Hospital de Clinicas of the University
        • Contact:
          • Ricardo P. de la Hoz
      • Buenos Aires, Argentina
        • Recruiting
        • Sanatorio Güemes Hospital
        • Contact:
          • Ezequiel J. Zaidel
  • Bangladesh
      • Dhaka, Bangladesh
        • Recruiting
        • Bangladesh Specialized Hospital (BSH)
        • Contact:
          • Talukder, Dr
      • Dhaka, Bangladesh
        • Recruiting
        • Dhaka Medical College Hospital (DMCH)
        • Contact:
          • Talukder, Dr
      • Dhaka, Bangladesh
        • Recruiting
        • DNCC Dedicated COVID-19 Hospital
        • Contact:
          • Talukder, Dr
      • Dhaka, Bangladesh
        • Recruiting
        • Kurmitola General Hospital (KGH)
        • Contact:
          • Talukder, Dr
      • Dhaka, Bangladesh
        • Recruiting
        • Kuwait Bangladesh Friendship Hospital
        • Contact:
          • Talukder, Dr
      • Dhaka, Bangladesh
        • Recruiting
        • Popular Medical College Hospital (PMCH)
        • Contact:
          • Talukder, Dr
  • Bosnia and Herzegovina
      • Srpska, Bosnia and Herzegovina
        • Recruiting
        • University Clinical center Republic of Srpska
        • Contact:
          • Bojan Stanetiic
  • Colombia
      • Bogotá, Colombia
        • Recruiting
        • Clinica del Occidente, Columbia
        • Contact:
          • Julián Lugo, Dr
      • Cali, Colombia
        • Recruiting
        • Fundacion Valle Del Lili
        • Contact:
          • Juan Gomez, Dr
  • Ghana
      • Kumasi, Ghana
        • Recruiting
        • Komfo Anokye Teaching Hospital
        • Contact:
          • Lambert T. Appiah
      • Kumasi, Ghana
        • Recruiting
        • Kumasi South Regional Hospital
        • Contact:
          • Lambert T. Appiah
  • India
      • Delhi, India
        • Recruiting
        • AIIMS, New Delhi
        • Contact:
          • nitish. naik, Dr
      • Hyderabad, India
        • Recruiting
        • Apollo Medical College, Jubilee Hills, Hyderabad, India
        • Contact:
          • Mahender Kumar, Dr.
      • Hyderabad, India
        • Recruiting
        • Apollol Hopsital,
        • Contact:
          • C. Venkata S. Ram, Dr.
      • Jodhpur, India
        • Recruiting
        • AIIMS Jodhpur
        • Contact:
          • Surendra Deora, Dr
    • Punjab
      • Ludhiyana, Punjab, India
        • Recruiting
        • Dayanand medical college hospital
        • Contact:
          • Bishav Mohan, Dr
  • Iran, Islamic Republic of
      • Isfahan, Iran, Islamic Republic of
        • Recruiting
        • Amin Hospital
        • Contact:
          • Nizal Sarrafzadegan
      • Isfahan, Iran, Islamic Republic of
        • Recruiting
        • Khorshid Hospital
        • Contact:
          • Sayed M. Hashemi
  • Japan
      • Kyoto, Japan
        • Recruiting
        • Kyoto Medical Center
        • Contact:
          • Koji Hasegawa, Dr
      • Kyoto, Japan
        • Recruiting
        • National Hospital Organization Kyoto Medical Center, Japan
        • Contact:
          • Koji Hasegawa, Dr
  • Kenya
      • Mombasa, Kenya
        • Recruiting
        • CGTRH-MOMBASA, Kenya
        • Contact:
          • ELIJAH OGOLA, PROF.
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Recruiting
        • UMMC
        • Contact:
          • Hooi Min Lim, Dr
  • Mexico
      • Guanajuato, Mexico
        • Recruiting
        • ISSSTE Clinica Hospital, Guanajuato
        • Contact:
          • Aurelio, Dr
  • Nigeria
      • Ibadan, Nigeria
        • Recruiting
        • University College Hospital, Nigeria
        • Contact:
          • Okechukwu S Ogah, Dr
      • Sagamu, Nigeria
        • Recruiting
        • Olabisi Onabanjo University Teaching Hospital (OOUTH)
        • Contact:
          • Francisca Inofomoh, Dr
  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Recruiting
        • Tabba Heart Institute
        • Contact:
          • Sana Sheikh, Dr
  • Portugal
      • Lisbon, Portugal
        • Recruiting
        • University Hospital Sta Maria, Portugal
        • Contact:
          • Fausto Pinto, Dr
  • South Africa
      • Cape Town, South Africa
        • Recruiting
        • Groote Schuur Hospital, South Africa
        • Contact:
          • Ntobeko Ntusi, Prof
  • Sudan
      • Khartoum, Sudan
        • Recruiting
        • Fedail Hospital
        • Contact:
          • Ahmed Suliman
  • Zambia
      • Lusaka, Zambia
        • Recruiting
        • Levy Mwanawasa University Hospital, Zambia
        • Contact:
          • Fastone Goma, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Outcome will be assessed at discharge and 30-day follow-up visit from the hospital admission date.
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.
at discharge and 30-day follow-up visits from the hospital admission date.
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.
at discharge and 30-day follow-up visits from the hospital admission date.
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
any time during the hospital admission and at 30-day follow-up.
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.
upto 30 days
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.
1-month after hospital discharge
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.
3-month after hospital discharge
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.
6-month after hospital discharge
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.
9-12-month after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Public Health Foundation of India

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Cape Town
Centre for Chronic Disease Control, India
World Heart Federation, Geneva, Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: KAREN SILWA, MD, PhD, University of Cape Town
  • Principal Investigator: Pablo PEREL, MD, PhD, London School of Hygiene and Tropical Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RA1413

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

IPD Sharing Time Frame

Two years after study completion and publication of main study results i.e., Dec 2023

IPD Sharing 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

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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