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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 belowSelect...
I am between 18 and 60 years old.
Select...
I have been diagnosed with Postural Tachycardia Syndrome.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
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.
Select...
I have severe liver problems.
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My rapid heartbeat when standing up is due to dehydration or long bed rest.
Select...
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.
Select...
I don't have any health issues that prevent me from taking propranolol or ivabradine.
Select...
I have a history of irregular heartbeats or devices like a pacemaker.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
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
808 Previous Clinical Trials
884,369 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking specific heart rhythm or blood pressure medications.I am not taking strong medications that affect liver enzyme CYP 3A4.Your blood pressure while lying down is lower than 90/60 mmHg.I have severe liver problems.My rapid heartbeat when standing up is due to dehydration or long bed rest.I cannot safely stop taking beta-blockers or ivabradine before the study starts.I have a heart condition such as valve disease, heart failure, or had a heart attack.I am unable to understand and agree to the study's procedures and risks.I am between 18 and 60 years old.Your heart rate when you are sitting still is less than 70 beats per minute and you are not taking any medications that lower your heart rate.I have diabetes or have had low blood sugar episodes.I don't have any health issues that prevent me from taking propranolol or ivabradine.I am either a man or a woman.You have a history of severe asthma or trouble breathing.I have been diagnosed with Postural Tachycardia Syndrome.I have a history of irregular heartbeats or devices like a pacemaker.
Research Study Groups:
This trial has the following groups:- Group 1: 1st drug Ivabradine
- Group 2: 2nd drug Ivabradine
- Group 3: 3rd drug Ivabradine
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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