ACTIVE_NOT_RECRUITING

RECOVER-AUTONOMIC: Platform Protocol, Appendix B (Ivabradine)

Conditions

Long COVID Long Covid19 Long Covid-19 PASC POTS

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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

This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. 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.

Official Title

RECOVER-AUTONOMIC (Ivabradine): Randomized Trial of the Effect of Ivabradine Versus Placebo on Long COVID Symptoms

Quick Facts

Study Start:2024-03-11

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06305806

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
* See NCT06305780 for RECOVER-AUTO: Platform Protocol level inclusion criteria which applies to this appendix (or sub-study)	1. A person of child-bearing potential who is not taking effective contraception 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

Inclusion Criteria

Exclusion Criteria

* See NCT06305780 for RECOVER-AUTO: Platform Protocol level inclusion criteria which applies to this appendix (or sub-study)

1. A person of child-bearing potential who is not taking effective contraception
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

Contacts and Locations

Principal Investigator

Christopher Grainger, MD

STUDY_CHAIR

Duke Clinical Research Institute

Cyndya Shibao, MD

STUDY_CHAIR

Vanderbilt University Medical Center

Peter Novak, MD

STUDY_CHAIR

Harvard

Pam Taub, MD

STUDY_CHAIR

University of California, San Diego

Tae Chung, MD

STUDY_CHAIR

Johns Hopkins University

Study Locations (Sites)

All sites listed under NCT06305780

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: Kanecia Obie Zimmerman

Christopher Grainger, MD, STUDY_CHAIR, Duke Clinical Research Institute
Cyndya Shibao, MD, STUDY_CHAIR, Vanderbilt University Medical Center
Peter Novak, MD, STUDY_CHAIR, Harvard
Pam Taub, MD, STUDY_CHAIR, University of California, San Diego
Tae Chung, MD, STUDY_CHAIR, Johns Hopkins University

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 Date2024-03-11

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-03-11

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

PASC
POTS

Additional Relevant MeSH Terms

Long COVID
Long Covid19
Long Covid-19