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If Channel Blocker

Propranolol vs Ivabradine for POTS

Phase 2
Recruiting
Led By Satish R Raj, MD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 18-60 years
Diagnosis of Postural Tachycardia Syndrome
Must not have
Concomitant use of class I and III antiarrhythmic agents, or non-dihydropyridine calcium channel blockers
Concomitant use of strong cytochrome P450 3A4 (CYP 3A4) inhibitors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks

Summary

This trial is designed to study whether the drugs ivabradine or propranolol can help reduce symptoms and improve quality of life for people with postural tachycardia syndrome (POTS).

Who is the study for?
This trial is for adults aged 18-60 with Postural Tachycardia Syndrome (POTS) who can consent to participate. Excluded are those with low heart rates or blood pressure, structural heart disease, diabetes, uncontrolled asthma, pregnancy, severe liver issues, certain medication use and specific heart rhythm problems.
What is being tested?
The study tests the effectiveness of Ivabradine versus Propranolol in managing POTS symptoms and heart rate upon standing. It's a double-blind placebo-controlled crossover trial where participants try each treatment for 4 weeks with breaks in between.
What are the potential side effects?
Potential side effects include slow heartbeat or high blood pressure from Ivabradine; fatigue, dizziness or breathing difficulties from Propranolol; both may cause other cardiovascular changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 60 years old.
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I have been diagnosed with Postural Tachycardia Syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking specific heart rhythm or blood pressure medications.
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I am not taking strong medications that affect liver enzyme CYP 3A4.
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I have severe liver problems.
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My rapid heartbeat when standing up is due to dehydration or long bed rest.
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I have a heart condition such as valve disease, heart failure, or had a heart attack.
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I am unable to understand and agree to the study's procedures and risks.
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I have diabetes or have had low blood sugar episodes.
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I don't have any health issues that prevent me from taking propranolol or ivabradine.
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I have a history of irregular heartbeats or devices like a pacemaker.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in HR
Secondary study objectives
Vanderbilt Orthostatic Symptoms Score

Trial Design

3Treatment groups
Active Control
Group I: 1st drug IvabradineActive Control3 Interventions
Patients will take Ivabradine first followed by Propranolol and Placebo
Group II: 2nd drug IvabradineActive Control3 Interventions
Patients will take either Propranolol or placebo first and then Ivabradine
Group III: 3rd drug IvabradineActive Control3 Interventions
Patients will take Propranolol and placebo first and then Ivabradine

Find a Location

Who is running the clinical trial?

Dysautonomia InternationalOTHER
5 Previous Clinical Trials
399 Total Patients Enrolled
5 Trials studying Postural Orthostatic Tachycardia Syndrome
399 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
University of CalgaryLead Sponsor
809 Previous Clinical Trials
886,340 Total Patients Enrolled
8 Trials studying Postural Orthostatic Tachycardia Syndrome
643 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Satish R Raj, MDPrincipal InvestigatorUniversity of Calgary
2 Previous Clinical Trials
108 Total Patients Enrolled

Media Library

Ivabradine (If Channel Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT04186286 — Phase 2
Postural Orthostatic Tachycardia Syndrome Research Study Groups: 1st drug Ivabradine, 2nd drug Ivabradine, 3rd drug Ivabradine
Postural Orthostatic Tachycardia Syndrome Clinical Trial 2023: Ivabradine Highlights & Side Effects. Trial Name: NCT04186286 — Phase 2
Ivabradine (If Channel Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04186286 — Phase 2
~4 spots leftby Dec 2025
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