← Back to Search

Ion Channel Blocker

Ivabradine + Coordinated Care for Long COVID Syndrome (RECOVER-AUTO Trial)

Phase 2

Waitlist Available

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to follow-up (6 months)

Awards & highlights

RECOVER-AUTO Trial Summary

This trial is a flexible study that can be used in different healthcare and community settings to help treat autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (

Who is the study for?

This trial is for individuals with long-term symptoms after COVID-19, known as Long COVID or PASC, who experience rapid heart rate upon standing (orthostatic tachycardia) and related symptoms. Participants should have a specific score on a questionnaire assessing autonomic dysfunction and not be enrolled in certain other sub-studies.Check my eligibility

What is being tested?

The study compares the effects of Ivabradine, a heart rate reducing medication, against a placebo. It also evaluates coordinated care versus usual healthcare practices to manage post-COVID autonomic dysfunction including cardiovascular issues and POTS.See study design

What are the potential side effects?

Ivabradine may cause side effects such as slow heart rate (bradycardia), high blood pressure, visual brightness (phosphenes), dizziness or fatigue. The extent of side effects can vary among individuals.

RECOVER-AUTO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to follow-up (6 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to follow-up (6 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to follow-up (6 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Orthostatic Hypotension Questionnaire (OHQ)/Orthostatic Intolerance Questionnaire (OIQ) Composite Score

Secondary outcome measures

Change in 6-min Walk Test

Change in Active Stand Test

Change in Composite Autonomic Symptoms Score 31 (COMPASS-31)

+10 more

Other outcome measures

Change in PASC Symptom Questionnaire

Change in Vanderbilt Orthostatic Symptoms Score (VOSS)

Changes in Autonomic Function Testing

RECOVER-AUTO Trial Design

4Treatment groups

Experimental Treatment

Group I: Ivabradine Placebo + Usual CareExperimental Treatment2 Interventions

Group II: Ivabradine Placebo + Coordinated CareExperimental Treatment2 Interventions

Group III: Ivabradine + Usual CareExperimental Treatment2 Interventions

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

Group IV: Ivabradine + Coordinated CareExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Usual Care

1990

Completed Phase 4

~7700

Ivabradine

2010

Completed Phase 4

~37620

Coordinated Care

2011

N/A

~640

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,365 Previous Clinical Trials

3,420,460 Total Patients Enrolled

Kanecia Obie ZimmermanLead Sponsor

8 Previous Clinical Trials

2,997 Total Patients Enrolled

Peter Novak, MDStudy ChairHarvard

2 Previous Clinical Trials

580 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for individuals to participate in this ongoing research study?

"As per clinicaltrials.gov, this particular study is currently not in search of new participants. Originally posted on March 1st, 2024, the trial was last updated on March 12th, 2024. Nonetheless, there are a total of 596 ongoing research projects that are actively seeking eligible candidates."

Answered by AI

Does the FDA authorize the use of Ivabradine in combination with Coordinated Care?

"Our assessment at Power ranks the safety of Ivabradine + Coordinated Care as a 2 on a scale from 1 to 3. This rating is due to ongoing Phase 2 research, indicating some evidence supporting safety without established efficacy data."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Kanecia Obie Zimmerman 2024. "RECOVER-AUTONOMIC: Platform Protocol, Appendix B (Ivabradine)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06305806.

All > Survivor Corps