WORLD HEART FEDERATION (WHF) COVID-19 and Cardiovascular Disease Survey
- Conditions
- COVID-19Cardiovascular Diseases
- Registration Number
- NCT04475471
- Lead Sponsor
- Public Health Foundation of India
- 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.
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5200
- All adults (as locally defined) with confirmed COVID-19 infection who are hospitalized are eligible.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of the patients for major adverse cardiovascular events (MACE) 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] 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 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
Persistence of long-COVID Symptoms at 6-month after discharge among survivors of COVID-19 hospitalizations. 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.
Impact of COVID-19 vaccination on clinical outcomes - MACE (major adverse cardiovascular events) in COVID-19 hospitalized patients. 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.
Persistence of long-COVID Symptoms at 3-month after discharge among survivors of COVID-19 hospitalizations. 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.
Persistence of long-COVID Symptoms at 9-12-month after discharge among survivors of COVID-19 hospitalizations. 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.
Assessment of the patients for Neurological Outcomes including stroke and Transient Ischemic Attack (TIA) 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.
Persistence of long-COVID Symptoms at 1-month after discharge among survivors of COVID-19 hospitalizations. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
Kyoto Medical Center
🇯🇵Kyoto, Japan
National Hospital Organization Kyoto Medical Center, Japan
🇯🇵Kyoto, Japan
Hospital de Clinicas of the University
🇦🇷Buenos Aires, Argentina
CGTRH-MOMBASA, Kenya
🇰🇪Mombasa, Kenya
Kurmitola General Hospital (KGH)
🇧🇩Dhaka, Bangladesh
Sanatorio Güemes Hospital
🇦🇷Buenos Aires, Argentina
Dhaka Medical College Hospital (DMCH)
🇧🇩Dhaka, Bangladesh
Komfo Anokye Teaching Hospital
🇬🇭Kumasi, Ghana
Kumasi South Regional Hospital
🇬🇭Kumasi, Ghana
UMMC
🇲🇾Kuala Lumpur, Malaysia
Tabba Heart Institute
🇵🇰Karachi, Sindh, Pakistan
Groote Schuur Hospital, South Africa
🇿🇦Cape Town, South Africa
Fundacion Valle del Lili
🇨🇴Cali, Colombia
Apollo Medical College, Jubilee Hills, Hyderabad, India
🇮🇳Hyderabad, India
Apollol Hopsital,
🇮🇳Hyderabad, India
University College Hospital, Nigeria
🇳🇬Ibadan, Nigeria
University Hospital Sta Maria, Portugal
🇵🇹Lisbon, Portugal
Popular Medical College Hospital (PMCH)
🇧🇩Dhaka, Bangladesh
Clinica del Occidente, Columbia
🇨🇴Bogotá, Colombia
Khorshid Hospital
🇮🇷Isfahan, Iran, Islamic Republic of
Dayanand medical college hospital
🇮🇳Ludhiyana, Punjab, India
Bangladesh Specialized Hospital (BSH)
🇧🇩Dhaka, Bangladesh
DNCC Dedicated COVID-19 Hospital
🇧🇩Dhaka, Bangladesh
AIIMS, New Delhi
🇮🇳Delhi, India
AIIMS Jodhpur
🇮🇳Jodhpur, India
Fedail Hospital
🇸🇩Khartoum, Sudan
Amin Hospital
🇮🇷Isfahan, Iran, Islamic Republic of
Levy Mwanawasa University Hospital, Zambia
🇿🇲Lusaka, Zambia
ISSSTE Clinica Hospital, Guanajuato
🇲🇽Guanajuato, Mexico
Kuwait Bangladesh Friendship Hospital
🇧🇩Dhaka, Bangladesh
University Clinical Center Republic of Srpska
🇧🇦Srpska, Bosnia and Herzegovina
Olabisi Onabanjo University Teaching Hospital (OOUTH)
🇳🇬Sagamu, Nigeria