Actively Recruiting

Phase 2
Age: 18Years - 60Years
All Genders
NCT04186286

Crossover Study of Propranolol vs Ivabradine in POTS

Led by University of Calgary · Updated on 2024-05-09

20

Participants Needed

1

Research Sites

308 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

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.

CONDITIONS

Official Title

Crossover Study of Propranolol vs Ivabradine in POTS

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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 postural tachycardia
  • Structural heart disease such as moderate or greater valvular disease, heart failure, left ventricular impairment, hypertrophic cardiomyopathy, coronary artery disease, or prior heart attack
  • History of tachyarrhythmias including supraventricular tachycardia, atrial fibrillation, or ventricular tachyarrhythmias
  • Known long QT interval or congenital long QT syndrome
  • History of sick sinus syndrome or high degree AV block
  • Presence of pacemaker, defibrillator, or cardiac resynchronization device
  • Diabetes mellitus or history of low blood sugar episodes
  • History of bronchospasm or uncontrolled asthma
  • Pregnant or breastfeeding
  • Unable to safely stop beta-blockers or ivabradine before study
  • Use of certain antiarrhythmic drugs or calcium channel blockers
  • Use of strong CYP 3A4 inhibitors
  • Severe liver impairment
  • Any contraindication to propranolol or ivabradine
  • Unable to give informed consent

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of Calgary

Calgary, Alberta, Canada, T2N 1N4

Actively Recruiting

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Research Team

S

Satish Raj, MD

CONTACT

S

Shahana Safdar

CONTACT

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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