NCT05530317 CArdiac REhabilitation for Building Exertional heArt Rate for Chronotropic Incompetence in Long COVID-19
| NCT ID | NCT05530317 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Long COVID |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-12-21 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2022-12-21 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion 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. Exclusion Criteria: 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
Contact & Investigator
Matthew S Durstenfeld, MD MAS
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT05530317 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Long COVID. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05530317 currently recruiting?
Yes, NCT05530317 is actively recruiting participants. Contact the research team at matthew.durstenfeld@ucsf.edu for enrollment information.
Where is the NCT05530317 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT05530317 clinical trial?
NCT05530317 is sponsored by University of California, San Francisco. The principal investigator is Matthew S Durstenfeld, MD MAS at University of California, San Francisco. The trial plans to enroll 20 participants.
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