COVID-19PCHF-COVICAVNCT04390555
The Global PCHF-COVICAV Registry
An observational study of COVID-19 and Cardiovascular Diseases, run by University of Zurich at 1 site in Switzerland.
Trial summary
Background: Coronavirus disease (COVID-19) is a tremendous challenge the modern world has never seen before and is overwhelming the capacities of healthcare systems worldwide. Patients with cardiovascular diseases, heart failure in particular, and cardiovascular risk factors seem to be at a very high risk if affected… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Cardiovascular Diseases, Cardiovascular Risk Factor
- How many people
- 1,500 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Apr 2020to Jul 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult inpatients (≥18 years old) with laboratory-confirmed COVID-19. Subjects with pre-existing cardiovascular disease and/or cardiac manifestations of COVID-19 infection (heart failure, acute coronary syndrome, myocarditis, arrhythmias, sudden cardiac arrest) and/or cardiovascular risk factors (dyslipidemia, hypertension, diabetes) are the focus of the study. Hospitalised subjects with COVID-19, but without cardiovascular disease or risk factors, will be used as a control population.
Who may be able to join
- Adult inpatients (≥18 years old) with laboratory-confirmed COVID-19.
Who cannot join
- Age <18 years old.
- Outpatients.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Zurich Heart Center, Unispital Zurich
Zurich, 8006
About this study
Official title: COVID-19 in Hospitalised Patients With Preexisting CArdioVascular Diseases and/or Cardiac Involvement and/or Cardiovascular Risk Factors: the Global PCHF-COVICAV Registry
Background: Coronavirus disease (COVID-19) is a tremendous challenge the modern world has never seen before and is overwhelming the capacities of healthcare systems worldwide. Patients with cardiovascular diseases, heart failure in particular, and cardiovascular risk factors seem to be at a very high risk if affected by COVID-19 - and vice versa there are more and more reports of cardiac manifestations with the viral disease.
Aim: The purpose of the study is to characterise the clinical course of adult inpatients with COVID-19 and concomitant cardiovascular affection in a worldwide, multicentre PCHF registry.
Methods: Retrospective and prospective data analysis. Data on demographic, clinical, selected laboratory, electrocardiography and echocardiography parameters, treatment and outcome will be collected. The principal investigator provides dedicated electronic case report form. The primary outcome is in-hospital mortality. The secondary endpoints will be ICU length of stay, hospital length of stay, the need and duration of invasive mechanical ventilation, cardiovascular hospitalisation after 3 and 6 months from index hospitalisation, all-cause and cardiovascular mortality after 3 and 6 months from index hospitalisation.
- Keywords
- COVID-19, Cardiovascular Diseases, Cardiovascular Risk Factor, Heart Failure
- Medical subject headings
- COVID-19, Cardiovascular Diseases, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CV involvement | Patients with COVID-19 and preexisting cardiovascular diseases and/or cardiovascular risk factors (diabetes mellitus, arterial hypertension and/or dyslipidaemia). | |
| Control | Patients with COVID-19 without preexisting cardiac involvement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality.
All-cause and cardiovascular mortality during index hospitalization.
Measured: Hospitalization period, assessed up to 30 days
Secondary outcomes (5)
The length of stay in the intensive care unit.
The duration of hospitalization on the intensive care unit.
Measured: Hospitalization period in the ICU, assessed up to 30 days
The duration of hospitalization.
The total length of stay in the hospital.
Measured: Hospitalization period, assessed up to 30 days
The need and duration of invasive mechanical ventilation.
Measured: Hospitalization period, assessed up to 30 days
Hospitalization for cardiovascular causes or cardiovascular deaths within 3 months after hospitalization.
Measured: 3 months
Hospitalization for cardiovascular causes or cardiovascular deaths within 6 months after hospitalization.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start30 Apr 2020
- Primary completionDec 2020 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Wroclaw Medical University
- Responsible party
- Sponsor
- Investigators
- Frank Ruschitzka, Prof. Dr. med, Study director, University Hospital Zurich, Zurich, SwitzerlandAndreas Flammer, PD Dr. med, Principal investigator, University Hospital Zurich, Zurich, SwitzerlandMateusz Sokolski, MD, PhD, Principal investigator, Wroclaw Medical University, Wroclaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390555
- Sponsor's protocol ID
- PCHF-COVICAV
- Acronym
- PCHF-COVICAV
- Status last verified
- May 2020
- First submitted
- 6 May 2020
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 May;46(5):846-848. doi: 10.1007/s00134-020-05991-x. Epub 2020 Mar 3. No abstract available.
PubMed 32125452Shi S, Qin M, Shen B, Cai Y, Liu T, Yang F, Gong W, Liu X, Liang J, Zhao Q, Huang H, Yang B, Huang C. Association of Cardiac Injury With Mortality in Hospitalized Patients With COVID-19 in Wuhan, China. JAMA Cardiol. 2020 Jul 1;5(7):802-810. doi: 10.1001/jamacardio.2020.0950.
PubMed 32211816Mehra MR, Desai SS, Kuy S, Henry TD, Patel AN. Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19. N Engl J Med. 2020 Jun 18;382(25):e102. doi: 10.1056/NEJMoa2007621. Epub 2020 May 1.
PubMed 32356626Cunningham JW, Ferreira JP, Deng H, Anker SD, Byra WM, Cleland JGF, Gheorghiade M, Lam CSP, La Police D, Mehra MR, Neaton JD, Spiro TE, van Veldhuisen DJ, Greenberg B, Zannad F. Natriuretic Peptide-Based Inclusion Criteria in a Heart Failure Clinical Trial: Insights From COMMANDER HF. JACC Heart Fail. 2020 May;8(5):359-368. doi: 10.1016/j.jchf.2019.12.009. Epub 2020 Mar 11.
PubMed 32171760Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
PubMed 32171076Guo T, Fan Y, Chen M, Wu X, Zhang L, He T, Wang H, Wan J, Wang X, Lu Z. Cardiovascular Implications of Fatal Outcomes of Patients With Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Jul 1;5(7):811-818. doi: 10.1001/jamacardio.2020.1017.
PubMed 32219356Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
PubMed 32031570Mehra MR, Ruschitzka F. COVID-19 Illness and Heart Failure: A Missing Link? JACC Heart Fail. 2020 Jun;8(6):512-514. doi: 10.1016/j.jchf.2020.03.004. Epub 2020 Apr 10. No abstract available.
PubMed 32360242Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PubMed 31986264Varga Z, Flammer AJ, Steiger P, Haberecker M, Andermatt R, Zinkernagel AS, Mehra MR, Schuepbach RA, Ruschitzka F, Moch H. Endothelial cell infection and endotheliitis in COVID-19. Lancet. 2020 May 2;395(10234):1417-1418. doi: 10.1016/S0140-6736(20)30937-5. Epub 2020 Apr 21. No abstract available.
PubMed 32325026Sokolski M, Trenson S, Reszka K, Urban S, Sokolska JM, Biering-Sorensen T, Hojbjerg Lassen MC, Skaarup KG, Basic C, Mandalenakis Z, Ablasser K, Rainer PP, Wallner M, Rossi VA, Lilliu M, Loncar G, Cakmak HA, Ruschitzka F, Flammer AJ. Phenotype clustering of hospitalized high-risk patients with COVID-19 - a machine learning approach within the multicentre, multinational PCHF-COVICAV registry. Cardiol J. 2024;31(4):512-521. doi: 10.5603/cj.98489. Epub 2024 Jun 4.
PubMed 38832553
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 in Hospitalised Patients With Preexisting CArdioVascular Diseases and/or Cardiac Involvement and/or Cardiovascular Risk Factors: the Global PCHF-COVICAV Registry
- ClinicalTrials.gov ID
- NCT04390555
- Acronym / sponsor ID
- PCHF-COVICAV / PCHF-COVICAV
- Keywords
- COVID-19, Cardiovascular Diseases, Cardiovascular Risk Factor, Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Wroclaw Medical University
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 15 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Coronavirus disease (COVID-19) is a tremendous challenge the modern world has never seen before and is overwhelming the capacities of healthcare systems worldwide. Patients with cardiovascular diseases, heart failure in particular, and cardiovascular risk factors seem to be at a very high risk if affected by COVID-19 - and vice versa there are more and more reports of cardiac manifestations with the viral disease.
Aim: The purpose of the study is to characterise the clinical course of adult inpatients with COVID-19 and concomitant cardiovascular affection in a worldwide, multicentre PCHF registry.
Methods: Retrospective and prospective data analysis. Data on demographic, clinical, selected laboratory, electrocardiography and echocardiography parameters, treatment and outcome will be collected. The principal investigator provides dedicated electronic case report form. The primary outcome is in-hospital mortality. The secondary endpoints will be ICU length of stay, hospital length of stay, the need and duration of invasive mechanical ventilation, cardiovascular hospitalisation after 3 and 6 months from index hospitalisation, all-cause and cardiovascular mortality after 3 and 6 months from index hospitalisation.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CV involvement | – | –Patients with COVID-19 and preexisting cardiovascular diseases and/or cardiovascular risk factors (diabetes mellitus, arterial hypertension and/or dyslipidaemia). |
| Control | – | –Patients with COVID-19 without preexisting cardiac involvement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult inpatients (≥18 years old) with laboratory-confirmed COVID-19. Subjects with pre-existing cardiovascular disease and/or cardiac manifestations of COVID-19 infection (heart failure, acute coronary syndrome, myocarditis, arrhythmias, sudden cardiac arrest) and/or cardiovascular risk factors (dyslipidemia, hypertension, diabetes) are the focus of the study. Hospitalised subjects with COVID-19, but without cardiovascular disease or risk factors, will be used as a control population.
Key inclusion criteria (1 listed)
- Adult inpatients (≥18 years old) with laboratory-confirmed COVID-19.
Key exclusion criteria (2 listed)
- Age <18 years old.
- Outpatients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-hospital mortality.
Time frame: Hospitalization period, assessed up to 30 days
All-cause and cardiovascular mortality during index hospitalization.
5 secondary outcomes
The length of stay in the intensive care unit.
Time frame: Hospitalization period in the ICU, assessed up to 30 days
The duration of hospitalization.
Time frame: Hospitalization period, assessed up to 30 days
The need and duration of invasive mechanical ventilation.
Time frame: Hospitalization period, assessed up to 30 days
Hospitalization for cardiovascular causes or cardiovascular deaths within 3 months after hospitalization.
Time frame: 3 months
Hospitalization for cardiovascular causes or cardiovascular deaths within 6 months after hospitalization.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
- Background: PubMed 32125452Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 May;46(5):846-848. doi: 10.1007/s00134-020-05991-x. Epub 2020 Mar 3. No abstract available.
- Background: PubMed 32211816Shi S, Qin M, Shen B, Cai Y, Liu T, Yang F, Gong W, Liu X, Liang J, Zhao Q, Huang H, Yang B, Huang C. Association of Cardiac Injury With Mortality in Hospitalized Patients With COVID-19 in Wuhan, China. JAMA Cardiol. 2020 Jul 1;5(7):802-810. doi: 10.1001/jamacardio.2020.0950.
- Background: PubMed 32356626Mehra MR, Desai SS, Kuy S, Henry TD, Patel AN. Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19. N Engl J Med. 2020 Jun 18;382(25):e102. doi: 10.1056/NEJMoa2007621. Epub 2020 May 1.
- Background: PubMed 32171760Cunningham JW, Ferreira JP, Deng H, Anker SD, Byra WM, Cleland JGF, Gheorghiade M, Lam CSP, La Police D, Mehra MR, Neaton JD, Spiro TE, van Veldhuisen DJ, Greenberg B, Zannad F. Natriuretic Peptide-Based Inclusion Criteria in a Heart Failure Clinical Trial: Insights From COMMANDER HF. JACC Heart Fail. 2020 May;8(5):359-368. doi: 10.1016/j.jchf.2019.12.009. Epub 2020 Mar 11.
- Background: PubMed 32171076Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
- Background: PubMed 32219356Guo T, Fan Y, Chen M, Wu X, Zhang L, He T, Wang H, Wan J, Wang X, Lu Z. Cardiovascular Implications of Fatal Outcomes of Patients With Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Jul 1;5(7):811-818. doi: 10.1001/jamacardio.2020.1017.
- Background: PubMed 32031570Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
- Background: PubMed 32360242Mehra MR, Ruschitzka F. COVID-19 Illness and Heart Failure: A Missing Link? JACC Heart Fail. 2020 Jun;8(6):512-514. doi: 10.1016/j.jchf.2020.03.004. Epub 2020 Apr 10. No abstract available.
- Background: PubMed 31986264Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
- Background: PubMed 32325026Varga Z, Flammer AJ, Steiger P, Haberecker M, Andermatt R, Zinkernagel AS, Mehra MR, Schuepbach RA, Ruschitzka F, Moch H. Endothelial cell infection and endotheliitis in COVID-19. Lancet. 2020 May 2;395(10234):1417-1418. doi: 10.1016/S0140-6736(20)30937-5. Epub 2020 Apr 21. No abstract available.
- Derived from this study: PubMed 38832553Sokolski M, Trenson S, Reszka K, Urban S, Sokolska JM, Biering-Sorensen T, Hojbjerg Lassen MC, Skaarup KG, Basic C, Mandalenakis Z, Ablasser K, Rainer PP, Wallner M, Rossi VA, Lilliu M, Loncar G, Cakmak HA, Ruschitzka F, Flammer AJ. Phenotype clustering of hospitalized high-risk patients with COVID-19 - a machine learning approach within the multicentre, multinational PCHF-COVICAV registry. Cardiol J. 2024;31(4):512-521. doi: 10.5603/cj.98489. Epub 2024 Jun 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Ruschitzka, Prof. Dr. med study director
University Hospital Zurich, Zurich, Switzerland
Andreas Flammer, PD Dr. med principal investigator
University Hospital Zurich, Zurich, Switzerland
Mateusz Sokolski, MD, PhD principal investigator
Wroclaw Medical University, Wroclaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Cardiovascular Diseases, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mateusz Sokolski, MD, PhD (+48717331112, mateusz.sokolski@umed.wroc.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality. (time frame: Hospitalization period, assessed up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04390555, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2020.