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New treatment option for Long COVID
Official title CArdiac REhabilitation for Building Exertional heArt Rate for Chronotropic Incompetence in Long COVID-19
ClinicalTrials.gov ID: NCT05530317
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 years or older
- Previously documented SARS-CoV-2 RNA positivity from an oral or nasal swab, as measured by a nucleic acid amplification test, documented positive...
- Presence of persistent symptoms, defined as at least one COVID-attributed symptom newly present during acute illness or worse than baseline and...
- Reduced exercise capacity \<100% predicted or self-reported reduction in exercise capacity compared to pre-COVID.
- Willing and able to actively participate in cardiac rehabilitation including attending at least 12 in person sessions at UCSF Parnassus (intervention...
You likely can't join if
- Pregnant or intention to become pregnant during study
- Pre-existing congenital heart disease, heart failure, pulmonary hypertension, heart or lung transplant, or cardiac valve surgery
- Myocardial infarction, or coronary artery bypass graft surgery, or new diagnosis of heart failure with a reduced ejection fraction \<40% within 90...
- Acute myocarditis diagnosed \<90 days prior
- Atrial fibrillation, atrial flutter, or other arrhythmias requiring antiarrhythmic therapy
- Use of beta-blockers, non-dihydropyridine calcium channel blockers or ivabradine
See the full eligibility criteria
- Age 18 years or older
- 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...
- 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...
- Reduced exercise capacity \<100% predicted or self-reported reduction in exercise capacity compared to pre-COVID.
- Willing and able to actively participate in cardiac rehabilitation including attending at least 12 in person sessions at UCSF Parnassus (intervention arm only).
- Agree to participate in the LIINC Study including the cardiovascular substudy if they are not already participating.
- Pregnant or intention to become pregnant during study
- Pre-existing congenital heart disease, heart failure, pulmonary hypertension, heart or lung transplant, or cardiac valve surgery
- 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)
- Acute myocarditis diagnosed \<90 days prior
- Atrial fibrillation, atrial flutter, or other arrhythmias requiring antiarrhythmic therapy
- Use of beta-blockers, non-dihydropyridine calcium channel blockers or ivabradine
- Implanted pacemaker or defibrillator
- Chronic lung disease requiring the use of home oxygen therapy
- Inability to ride a sitting bicycle for CPET
- Severe post-exertional malaise or symptom worsening that would preclude participation in cardiac rehabilitation
- Medical or psychological comorbidities that would prevent safe participation in the trial, in the opinion of the Principal Investigator
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.