RECRUITING

CArdiac REhabilitation for Building Exertional heArt Rate for Chronotropic Incompetence in Long COVID-19

Conditions

Long COVID COVID-19 chronotropic incompetence cardiac rehabilitation cardiopulmonary exercise testing

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this proof-of-concept clinical trial is to determine whether cardiac rehabilitation improves exercise capacity and chronotropic (heart rate) response to exercise among people with Long COVID. The study will include individuals with confirmed SARS-CoV-2 infection, symptoms not present prior to COVID-19 that are persistent for at least 3 months after acute infection ("Long COVID"), and who have reduced exercise capacity less than predicted and reduced heart rate response during cardiopulmonary exercise testing (CPET). In addition to the primary outcome of change in peak VO2, secondary outcomes will include change in symptoms including autonomic symptoms (COMPASS-31), anxiety (GAD-7), depression (PHQ-9), endothelial function with brachial artery flow-mediated dilation, and satisfaction (net-promotor score).

Official Title

CArdiac REhabilitation for Building Exertional heArt Rate for Chronotropic Incompetence in Long COVID-19 (CARE BEAR-LC): A Proof-of-Concept, Mechanistic Trial

Quick Facts

Study Start:2022-12-21

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05530317

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 18 years or older 2. Previously documented SARS-CoV-2 RNA positivity from an oral or nasal swab, as measured by a nucleic acid amplification test, documented positive antigen testing, or positive nucleocapsid antibody. Documentation of the positive test is required. 3. Presence of persistent symptoms, defined as at least one COVID-attributed symptom newly present during acute illness or worse than baseline and reported to still be present for at least 90 days following symptom onset. This will be ascertained using study case report forms. 4. Reduced exercise capacity \<100% predicted or self-reported reduction in exercise capacity compared to pre-COVID. 5. Willing and able to actively participate in cardiac rehabilitation including attending at least 12 in person sessions at UCSF Parnassus (intervention arm only). 6. Agree to participate in the LIINC Study including the cardiovascular substudy if they are not already participating.	1. Pregnant or intention to become pregnant during study 2. Pre-existing congenital heart disease, heart failure, pulmonary hypertension, heart or lung transplant, or cardiac valve surgery 3. Myocardial infarction, or coronary artery bypass graft surgery, or new diagnosis of heart failure with a reduced ejection fraction \<40% within 90 days prior to enrollment (Class I indications for cardiac rehabilitation) 4. Acute myocarditis diagnosed \<90 days prior 5. Atrial fibrillation, atrial flutter, or other arrhythmias requiring antiarrhythmic therapy 6. Use of beta-blockers, non-dihydropyridine calcium channel blockers or ivabradine 7. Implanted pacemaker or defibrillator 8. Chronic lung disease requiring the use of home oxygen therapy 9. Inability to ride a sitting bicycle for CPET 10. Severe post-exertional malaise or symptom worsening that would preclude participation in cardiac rehabilitation 11. Medical or psychological comorbidities that would prevent safe participation in the trial, in the opinion of the Principal Investigator

Inclusion Criteria

Exclusion Criteria

1. Age 18 years or older
2. Previously documented SARS-CoV-2 RNA positivity from an oral or nasal swab, as measured by a nucleic acid amplification test, documented positive antigen testing, or positive nucleocapsid antibody. Documentation of the positive test is required.
3. Presence of persistent symptoms, defined as at least one COVID-attributed symptom newly present during acute illness or worse than baseline and reported to still be present for at least 90 days following symptom onset. This will be ascertained using study case report forms.
4. Reduced exercise capacity \<100% predicted or self-reported reduction in exercise capacity compared to pre-COVID.
5. Willing and able to actively participate in cardiac rehabilitation including attending at least 12 in person sessions at UCSF Parnassus (intervention arm only).
6. Agree to participate in the LIINC Study including the cardiovascular substudy if they are not already participating.

1. Pregnant or intention to become pregnant during study
2. Pre-existing congenital heart disease, heart failure, pulmonary hypertension, heart or lung transplant, or cardiac valve surgery
3. Myocardial infarction, or coronary artery bypass graft surgery, or new diagnosis of heart failure with a reduced ejection fraction \<40% within 90 days prior to enrollment (Class I indications for cardiac rehabilitation)
4. Acute myocarditis diagnosed \<90 days prior
5. Atrial fibrillation, atrial flutter, or other arrhythmias requiring antiarrhythmic therapy
6. Use of beta-blockers, non-dihydropyridine calcium channel blockers or ivabradine
7. Implanted pacemaker or defibrillator
8. Chronic lung disease requiring the use of home oxygen therapy
9. Inability to ride a sitting bicycle for CPET
10. Severe post-exertional malaise or symptom worsening that would preclude participation in cardiac rehabilitation
11. Medical or psychological comorbidities that would prevent safe participation in the trial, in the opinion of the Principal Investigator

Contacts and Locations

Study Contact

Matthew S Durstenfeld, MD MAS

CONTACT

628-206-5562

matthew.durstenfeld@ucsf.edu

Principal Investigator

Matthew S Durstenfeld, MD MAS

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco

San Francisco, California, 94110

United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

Matthew S Durstenfeld, MD MAS, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

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 Registration Dates

Study Start Date2022-12-21

Study Completion Date2025-09

Study Record Updates

Study Start Date2022-12-21

Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

chronotropic incompetence
cardiac rehabilitation
cardiopulmonary exercise testing

Additional Relevant MeSH Terms

Long COVID
COVID-19