Actively Recruiting
A Randomized Crossover Study of Propranolol Versus Ivabradine in Postural Tachycardia Syndrome (POTS)
Led by University of Calgary · Updated on 2024-05-09
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Calgary
Lead Sponsor
D
Dysautonomia International
Collaborating Sponsor
AI-Summary
What this Trial Is About
Postural tachycardia syndrome (POTS) is a condition causing symptoms like palpitations, lightheadedness, chest discomfort, shortness of breath, blurred vision, and mental clouding upon standing due to a rapid increase in heart rate without low blood pressure. POTS significantly reduces quality of life and daily functioning. This trial evaluates and compares the effects of two drugs, propranolol and ivabradine, on heart rate response to standing and symptom burden in POTS patients through a randomized crossover design. Participants will undergo three separate 4-week treatment periods with oral ivabradine, propranolol, or placebo, separated by 7-day washout phases. Ivabradine is given as 5 mg twice daily plus placebo twice daily to match a four-times-daily schedule, propranolol as 10 mg four times daily, and placebo as four times daily. Each participant receives all three treatments in random order, acting as their own control. The study includes baseline screening and assessments after each treatment phase. Throughout the study, participants attend four visits for testing including tilt table exams to measure heart rate changes during head-up tilt, neuropsychological testing for memory and attention, and continuous monitoring of blood pressure and electrocardiogram. They also complete symptom and quality of life questionnaires. After each visit, a 24-hour heart rhythm monitor is worn. The entire trial involves close monitoring of heart rate changes and symptom evaluation over several months.
CONDITIONS
Brief Title
Crossover Study of Propranolol vs Ivabradine in POTS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Postural Tachycardia Syndrome
- Age between 18-60 years
- Men and women are eligible
- Able and willing to provide informed consent
You will not qualify if you...
- Seated resting heart rate less than 70 bpm without rate-lowering medications
- Supine blood pressure less than 90/60 mmHg
- Acute dehydration or prolonged bed rest causing tachycardia
- Structural heart disease including moderate or worse valve disease, heart failure, left ventricular dysfunction, hypertrophic cardiomyopathy, coronary artery disease, or prior heart attack
- History of tachyarrhythmias such as supraventricular tachycardia or atrial fibrillation
- Long QT interval or sick sinus syndrome
- Presence of pacemaker or defibrillator device
- Diabetes or history of low blood sugar episodes
- History of bronchospasm or uncontrolled asthma
- Pregnancy or breastfeeding
- Unable to safely stop beta-blockers or ivabradine before the study
- Use of certain antiarrhythmic or calcium channel blocker medications
- Use of strong CYP 3A4 inhibitors
- Severe liver impairment
- Any contraindication to propranolol or ivabradine per product guidelines
- Unable to give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants undergo a 7-day washout period to stop certain medications before starting treatment.
No visits required during washout
Duration - 4 weeks per treatment course with 7-day washout between courses
Participants receive three different 4-week courses of oral treatments: ivabradine, propranolol, and placebo, with a 7-day washout between each. Each participant acts as their own control in this randomized crossover design.
4 in-person visits for POTS testing at baseline and after each treatment course
Duration - 1 day after each treatment phase
Participants are monitored with 24-hour Holter monitoring after each treatment phase to assess heart rate and symptoms.
1 visit to return Holter monitor device after 24-hour monitoring
Trial Site Locations
Total: 1 location
1
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
Actively Recruiting
Research Team
S
Satish Raj, MD
S
Shahana Safdar
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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