RECOVER-AUTONOMIC: Platform Protocol, Appendix B (Ivabradine)
NCT ID: NCT06305806
Last Updated: 2025-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
181 participants
INTERVENTIONAL
2024-03-11
2025-12-31
Brief Summary
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This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs.
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Detailed Description
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Interventions will be added to the platform protocol as appendices. Each appendix will leverage all elements of the platform protocol, with additional elements described in the individual appendix.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ivabradine + Coordinated Care
The starting dose will be 5 mg twice a day, and the dose will be modified if needed at the 1 month clinic visit. At this visit, HR will be measured and the dose will be modified as applicable. The maximum dose will be 7.5 mg twice daily if HR is ˃ 90 bpm.
The table below provides the dosing of ivabradine based on HR.
Supine Resting HR 60-80 2.5 mg BID Supine Resting HR \>80 5 mg BID Supine Resting HR \>90 7.5 mg BID
\*Resting HR should be measured 5 minutes after lying down
Ivabradine
Participants will receive ivabradine for 3 months (12 weeks) with a follow-up period for an additional 3 months (total study duration of 6 months).
Coordinated Care
Participants will receive coordinated non-pharmacologic care for a duration of 3 months, concurrent with ivabradine administration. Coordinated non-pharmacologic care involves volume expansion through high salt diet, water intake, abdominal binder, exercise/rehabilitation, motivation, education, and assisted care through care coordinator.
Ivabradine Placebo + Coordinated Care
Ivabradine Placebo
The control (placebo) oral tablets will be similar to the study drug, ivabradine.
The control packaging matches the packaging.
Participants will receive placebo for 3 months (12 weeks) with a follow-up period for an additional 3 months (total study duration of 6 months).
Coordinated Care
Participants will receive coordinated non-pharmacologic care for a duration of 3 months, concurrent with ivabradine administration. Coordinated non-pharmacologic care involves volume expansion through high salt diet, water intake, abdominal binder, exercise/rehabilitation, motivation, education, and assisted care through care coordinator.
Ivabradine + Usual Care
The starting dose will be 5 mg twice a day, and the dose will be modified if needed at the 1 month clinic visit. At this visit, HR will be measured and the dose will be modified as applicable. The maximum dose will be 7.5 mg twice daily if HR is ˃ 90 bpm.
The table below provides the dosing of ivabradine based on HR.
Supine Resting HR 60-80 2.5 mg BID Supine Resting HR \>80 5 mg BID Supine Resting HR \>90 7.5 mg BID
\*Resting HR should be measured 5 minutes after lying down
Ivabradine
Participants will receive ivabradine for 3 months (12 weeks) with a follow-up period for an additional 3 months (total study duration of 6 months).
Usual Care
Participants will receive usual non-pharmacologic care (control) for a duration of 3 months, concurrent with ivabradine administration.
Ivabradine Placebo + Usual Care
Ivabradine Placebo
The control (placebo) oral tablets will be similar to the study drug, ivabradine.
The control packaging matches the packaging.
Participants will receive placebo for 3 months (12 weeks) with a follow-up period for an additional 3 months (total study duration of 6 months).
Usual Care
Participants will receive usual non-pharmacologic care (control) for a duration of 3 months, concurrent with ivabradine administration.
Interventions
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Ivabradine
Participants will receive ivabradine for 3 months (12 weeks) with a follow-up period for an additional 3 months (total study duration of 6 months).
Ivabradine Placebo
The control (placebo) oral tablets will be similar to the study drug, ivabradine.
The control packaging matches the packaging.
Participants will receive placebo for 3 months (12 weeks) with a follow-up period for an additional 3 months (total study duration of 6 months).
Coordinated Care
Participants will receive coordinated non-pharmacologic care for a duration of 3 months, concurrent with ivabradine administration. Coordinated non-pharmacologic care involves volume expansion through high salt diet, water intake, abdominal binder, exercise/rehabilitation, motivation, education, and assisted care through care coordinator.
Usual Care
Participants will receive usual non-pharmacologic care (control) for a duration of 3 months, concurrent with ivabradine administration.
Eligibility Criteria
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Inclusion Criteria
2. COMPASS-31 Score \> 25 and not enrolled in the IVIG appendix
Exclusions Criteria:
Exclusion Criteria
2. Use of the following medications: clonidine, tizanidine, amphetamines, and serotonin and norepinephrine reuptake inhibitors (SNRIs) with the exception of modafinil
3. Use of beta-blockers (any formulation), calcium channel blockers, midodrine, pyridostigmine, fludrocortisone, and guanfacine will be excluded unless participant is on a stable dose (\>4 weeks). Participants on stable doses will be allowed to continue the medication throughout the study.
4. Combination with verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate reducing properties
5. Lactating and breast-feeding women
6. Severe hepatic impairment
7. Use of drugs known to prolong the QT-interval (e.g., quinidine, disopyramide, bepridil, sotalol, amiodarone, pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine
8. Concomitant use of digoxin
9. Participants who are pacemaker dependent
10. Patients with hypokalemia (serum K+\<3.5 mEq/L)
11. Patients taking potassium-depleting diuretics
12. A history of congenital or acquired long QT syndrome, with or without torsade de pointes
13. Patients with high degree AV block such as Mobitz II
18 Years
ALL
No
Sponsors
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Kanecia Obie Zimmerman
OTHER
Responsible Party
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Kanecia Obie Zimmerman
Associate Professor of Pediatrics
Principal Investigators
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Christopher Grainger, MD
Role: STUDY_CHAIR
Duke Clinical Research Institute
Cyndya Shibao, MD
Role: STUDY_CHAIR
Vanderbilt University Medical Center
Peter Novak, MD
Role: STUDY_CHAIR
Harvard
Pam Taub, MD
Role: STUDY_CHAIR
University of California, San Diego
Tae Chung, MD
Role: STUDY_CHAIR
Johns Hopkins University
Locations
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All sites listed under NCT06305780
Durham, North Carolina, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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Related Info
Other Identifiers
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OTA-21-015G
Identifier Type: OTHER
Identifier Source: secondary_id
Pro00112597_B
Identifier Type: -
Identifier Source: org_study_id
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