Ivabradine for Long-Term Effects of COVID-19 With POTS Cohort (NCT05481177) | Clinical Trial Compass
UnknownPhase 4
Ivabradine for Long-Term Effects of COVID-19 With POTS Cohort
United States250 participantsStarted 2023-06-14
Plain-language summary
The purpose of the study is three-fold. The primary aim is to identify the proportion of Long-Haul COVID (LHC) and non-LHC volunteers with relevant symptoms actually have postural orthostatic tachycardia syndrome (POTS). The second is to determine benefit of ivabradine treatment. Ivabradine is a drug approved to treat tachycardia in persons with heart failure. The third is to characterize risk factors and outcomes among volunteers with and without LHC. This will include comparison with COVID-19-positive individuals who did not develop long-COVID symptoms.
The study will improve basic and applied knowledge of LHC and its associated cardiovascular and autonomic consequences. Cellular and molecular characterization of LHC and non-LHC participants will be performed with a nested clinical trial for Ivabradine responsiveness on reduction of tachycardia. It is hoped that a greater understanding of LHC, and related autonomic dysfunction in particular will help to identify treatment paradigms and therapeutic targets for improving recovery and enhancing health for those affected.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age 18-80
✓. History of documented COVID-19 infection of any severity to include a positive COVID-19 PCR, or antibody test
✓. Meets criteria for 'long-haul' COVID-19 with symptoms \>12 weeks following acute illness
✓. Able and willing to provide informed consent and participate for study duration
✓. Willing to participate in the nested randomized controlled trial of ivabradine if RCT enrollment criteria are met
✓. Access to a primary healthcare provider and proof of health insurance
✓. Age 18-80
✓. History of documented COVID-19 infection of any severity to include a positive COVID-19 PCR, or antibody test
Exclusion criteria
✕. Resting heart rate \<60 bpm
✕. Atrial fibrillation
What they're measuring
1
Change in standing heart rate following 3 months treatment.
Timeframe: 3 months
Trial details
NCT IDNCT05481177
SponsorUniformed Services University of the Health Sciences
✕. Allergic reaction or known contraindications to study drug
✕. Acute decompensated heart failure
✕. Clinically significant hypotension, defined as a drop in systolic BP \>20 mmHg or drop in diastolic \>10 mmHg during orthostatic vital signs testing.
✕. Sick sinus syndrome, sinoatrial block or 3rd degree AV block, unless a functioning demand pacemaker is present