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Compares treatment options for Postural Tachycardia Syndrome
Official title Crossover Study of Propranolol vs Ivabradine in POTS
ClinicalTrials.gov ID: NCT04186286
What this study is testing
What is Ivabradine 4-week course?
Ivabradine 4-week course is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for postural tachycardia syndrome.
Also referred to as Lancora.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Diagnosis of Postural Tachycardia Syndrome
- Age between 18-60 years
- Men and women are eligible
- Able and willing to provide informed consent
You likely can't join if
- 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
See the full eligibility criteria
- Diagnosis of Postural Tachycardia Syndrome
- Age between 18-60 years
- Men and women are eligible
- Able and willing to provide informed consent
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.