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Impact of COVID-19 on the Benefit of Cardiac Rehabilitation (REACARDIOCOVID)

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: NCT04513964
Recruitment Status : Recruiting
First Posted : August 14, 2020
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Study Description
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Brief Summary:

The COVID-19 attack is polymorphic with otorhinolaryngological, pneumological, cardiac, digestive, neurological, muscular attacks with a higher mortality in subjects with comorbidity [> 70 years old, cardiovascular history in particular Arterial hypertension (hypertension ), heart disease…]. This polymorphism is linked to vasculitis and the immune response.

Patients with cardiovascular disease are particularly at risk of decompensating, particularly due to the increased metabolism induced by viral infection and reduced cardiovascular capacities.

On the cardiovascular level, two sides can be considered. On the one hand, cardiovascular disease (hypertension, coronary artery disease) is a comorbid factor. On the other hand, the myocardial damage reflected by the increase in troponin or an alteration of the ejection fraction is a very clear risk factor for death or severe form.

Cardiovascular involvement is particularly high in hospitalized and deceased patients. The odds ratio calculated in a meta-analysis of severe forms of covid-19 with hypertension is 3 [1.9; 3.1], for cardiovascular pathologies of 2.93 [1.73; 4.96]. Recommendations were made for pulmonary rehabilitation but not for cardiovascular rehabilitation.

Cardiac rehabilitation is indicated in most cardiovascular pathologies (after acute coronary syndrome, after coronary angioplasty, in heart failure, after coronary or valve heart surgery, etc.).

It consists of a multidisciplinary approach combining therapeutic pharmacological adjustment, physical activity, therapeutic education in order to improve physical capacities for exertion and reduce morbidity and mortality. The physical exercises can be endurance or resistance type.

Capacity gain at the end of rehabilitation is measured by visual scales, quality of life questionnaires, and a stress test at the start and end of rehabilitation. Most often, rehabilitation centers only do the stress test and estimate through questioning for subjective improvement.

The hypothesis is that patients who contracted COVID-19 would have lower cardiac capacities after recovery from the infection than patients without COVID-19 or that their capacity for recovery would be less. There could be a difference in recovery after cardiac rehabilitation between the two populations regardless of whether the cardiac damage requiring rehabilitation was triggered by COVID-19 or was pre-existing.


Condition or disease
Heart Failure Covid19

Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Impact of COVID-19 on the Benefit of Cardiac Rehabilitation
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Control
Patient not suffering from COVID-19
COVID-19
Patient who has been infected with COVID-19 with suggestive signs and authentication by PCR or thoracic CT or serology


Outcome Measures
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Primary Outcome Measures :
  1. Impact of COVID-19 on exercise capacity gain after cardiovascular rehabilitation [ Time Frame: Month 3 ]
    This outcome corresponds to the difference between the average gain in exercise capacity after cardiac rehabilitation between the two groups of patients Control and COVID-19.


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:   Non-Probability Sample
Study Population
This study will be carried out on the data of patients referred for outpatient cardiovascular rehabilitation in one of the participating centers between 02/01/2020 and 12/31/2020, patients affected or not by COVID-19, i.e. around 60 patients in total.
Criteria

Inclusion Criteria:

  • Patient aged ≥ 18 years
  • Patient referred for outpatient cardiovascular rehabilitation in one of the participating centers between 02/01/2020 and 12/31/2020
  • French-speaking patient

Exclusion Criteria:

  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under legal protection
  • Patient objecting to the use of their data as part of this research
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): NCT04513964


Contacts
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Contact: DUC Philippe, MD 0144127883 ext +33 pduc@ghpsj.fr
Contact: BEAUSSIER Helene, PharmD, pHD 0144127883 ext +33 crc@ghpsj.fr

Locations
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France
Groupe Hospitalier Paris Saint-Joseph Recruiting
Paris, Groupe Hospitalier Paris Saint-Joseph, France, 75014
Contact: Philippe DUC, MD       pduc@ghpsj.fr   
Hôpital Corentin Celton Not yet recruiting
Issy-les-Moulineaux, France, 92130
Contact: Iliou Marie-Christine, MD       marie-christine.iliou@aphp.fr   
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
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Study Director: DUC Philippe, MD Groupe Hospitalier Paris Saint Joseph
More Information
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Publications of Results:

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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT04513964    
Other Study ID Numbers: READCARDIOCOVID
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases