Crossover Study of Propranolol vs Ivabradine in POTS

Launched by UNIVERSITY OF CALGARY · Dec 2, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating how well two different medications, propranolol and ivabradine, can help people with Postural Tachycardia Syndrome (POTS). POTS is a condition that causes an unusually fast heart rate when standing, which can lead to symptoms like palpitations, lightheadedness, and mental clouding. The goal of the study is to see which medication is more effective in lowering heart rate and reducing symptoms for patients with this condition.

To participate in the trial, individuals must be between 18 and 60 years old and have a diagnosis of POTS. Participants will go through three different treatment phases, each lasting four weeks, where they will receive one of the medications or a placebo (a pill with no active ingredients). After each phase, they will complete questionnaires about their symptoms and have tests to measure how their heart responds to standing. The study is currently recruiting participants, and those interested should consult with their healthcare provider to see if they meet the eligibility criteria.

Gender

ALL

Eligibility 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