A Randomized Crossover Study of Propranolol Versus Ivabradine in Postural Tachycardia Syndrome (POTS)

Who is this study for? Patients with Postural Tachycardia Syndrome
What treatments are being studied? Ivabradine+Propranolol
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

1.0 BACKGROUND Postural tachycardia syndrome (POTS) is a disorder of chronic orthostatic intolerance characterized by symptoms of palpitations, lightheadedness, chest discomfort, shortness of breath, blurred vision, and mental clouding. These symptoms occur during standing and are associated with a marked increase in heart rate (HR) in the absence of hypotension, which typically resolve when sitting or lying down. Most importantly, POTS is associated with a very poor quality of life and significant functional disability. POTS patients commonly experience mental clouding (brain fog) even while lying down or seated, which poses significant limitations to daily activities . Unfortunately, there is a relative paucity in the literature assessing therapies for POTS patients. Given that excessive tachycardia on standing is a fundamental component of this syndrome, a handful of studies have evaluated medications that reduce HR. Ivabradine is newer drug that is a selective If channel blocker that reduces HR without affecting other cardiovascular functions. 2.0 RATIONALE / STUDY PURPOSE The investigators propose to compare the efficacy of propranolol and ivabradine on HR response to standing, and symptom burden in patients with POTS. 3.0 Study Design This will be a single-center double-blind placebo-controlled randomized crossover trial conducted in patients with POTS to compare effects of (1) oral ivabradine 5 mg bid plus placebo BID (to fill out a QID schedule); (2) oral propranolol 10 mg qid; and (3) oral placebo qid in POTS patients. After a baseline screening assessment following a washout period of 7 days, participants will be randomized to start with a 4-week course of either ivabradine, propranolol or placebo. The other two treatments will be given in separate 4-week courses with a 7-day washout period between phases, with each participant acting as his or her own control. At the end of each 4-week phase, participants will complete the symptom-rating and HRQOL questionnaires, and also undergo tilt table testing to assess the change in HR at 10 min with head up tilt. Participants will undergo POTS testing at baseline and at the end of each 4-week treatment course. This will involve a total of 4 separate study visits.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Diagnosis of Postural Tachycardia Syndrome

• Age between 18-60 years

• Men and women are eligible

• Able and willing to provide informed consent

Locations
Other Locations
Canada
University of Calgary
RECRUITING
Calgary
Contact Information
Primary
Satish Raj, MD
autonomic.research@ucalgary.ca
403-210-6152
Backup
Shahana Safdar
ssafdar@ucalgary.ca
403-220-8897
Time Frame
Start Date: 2021-02-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 20
Treatments
Active_comparator: 1st drug Ivabradine
Patients will take Ivabradine first followed by Propranolol and Placebo
Active_comparator: 2nd drug Ivabradine
Patients will take either Propranolol or placebo first and then Ivabradine
Active_comparator: 3rd drug Ivabradine
Patients will take Propranolol and placebo first and then Ivabradine
Sponsors
Leads: University of Calgary
Collaborators: Dysautonomia International

This content was sourced from clinicaltrials.gov