Comparing Propranolol and Ivabradine for treating POTS
A Randomized Crossover Study of Propranolol Versus Ivabradine in Postural Tachycardia Syndrome (POTS)
This study tests which medication, Propranolol or Ivabradine, works better to help people with Postural Tachycardia Syndrome feel better and manage their symptoms.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT04186286 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of two medications, Propranolol and Ivabradine, in treating Postural Tachycardia Syndrome (POTS), a condition characterized by an abnormal increase in heart rate upon standing. The study employs a crossover design, where participants will receive each treatment for four weeks, allowing for direct comparison of their effects on heart rate and symptoms. The primary goal is to assess which medication better alleviates the debilitating symptoms associated with POTS, such as palpitations and mental clouding. Participants will be monitored for changes in heart rate and symptom burden throughout the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-60 diagnosed with Postural Tachycardia Syndrome.
Not a fit: Patients with underlying structural heart disease or other specific cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from POTS, significantly improving their quality of life.
How similar studies have performed: Previous studies have shown some success with Propranolol in treating POTS, but the effectiveness of Ivabradine in this context is less established, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Postural Tachycardia Syndrome * Age between 18-60 years * Men and women are eligible * Able and willing to provide informed consent Exclusion Criteria: * Seated resting heart rate \< 70 bpm in the absence of rate-lowering medications * Supine blood pressure \< 90/60 mmHg * Overt cause for postural tachycardia, i.e., acute dehydration, prolonged bed rest * Presence of underlying structural heart disease including: * Valvular disease (i.e. moderate or greater valvular stenosis or regurgitation) * History of heart failure * Greater than mild left ventricular systolic impairment * Hypertrophic cardiomyopathy * Known coronary artery disease or prior myocardial infarction * History of tachyarrhythmias including: * Supraventricular tachycardia, atrial tachycardia, atrial fibrillation / flutter * Ventricular tachyarrhythmias * Pre-existing long QT interval (e.g. known congenital long QT syndrome, or QT interval \>500 ms) * History of sick sinus syndrome or high degree AV block * Presence of a pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy device * Diabetes mellitus or history of hypoglycemic episodes * History of bronchospasm or uncontrolled asthma * Pregnant (by history or serum test) or breast-feeding * Inability to safely withdraw from existing beta-blockers or ivabradine prior to the study day * 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 * Severe hepatic impairment * Any contraindication to propranolol or ivabradine not specifically listed above as per the product monographs. * Unable to give informed consent
Where this trial is running
Calgary, Alberta
- University of Calgary — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Satish R Raj, MD — University of Calgary
- Study coordinator: Satish Raj, MD
- Email: autonomic.research@ucalgary.ca
- Phone: 403-210-6152
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.