At a glance
ClinicalIndex Comparison Record- ✓Age 18-65 years
- ✓Confirmed POTS diagnosis, hyperadrenergic subtype with norepinephrine >600 pg/ml
- ✓Norepinephrine levels greater than 600 pg/ml
- ✓No structural heart disease
- ✕Thyroid or adrenal disorders
- ✕Medications that interfere with ivabradine (e.g., Cytochrome P450 drugs)
- ✕Peripheral autonomic neuropathy with peripheral edema and discolored toes
- ✕History of systemic illnesses (acute or chronic infectious, autoimmune/inflammatory disease, cancer, COPD, anemia, diabetes, or psychiatric illness)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome (a Double-blind Placebo-parallel Group Trial)
In Brief
A Phase 3 clinical trial evaluating Ivabradine and Placebo for Postural Orthostatic Tachycardia Syndrome. Completed, enrolled 37 participants across 1 site.
Detailed Summary
Postural orthostatic tachycardia syndrome (POTS) occurs in approximately 500,000 Americans, but predominates in women with a 5:1 ratio. Patients with POTS experience debilitating tachycardia upon postural changes such as standing that impairs their quality of life. Tachycardia is clinically defined as a heart rate greater than 100 beats/min; and in POTS patients, the prolonged heart rate increase is greater than 30 beats/min or increases to 120 beats/min within the first ten minutes of a diagnostic tilt table test without postural hypotension. There are currently no effective treatment methods for POTS. However, several studies suggest Ivabradine could be a main treatment option for POTS because Ivabradine specifically inhibits the f-channels (If) within the sinoatrial (SA) node, which slows the heart rate. Currently in the US, Ivabradine is mainly prescribed to treat chronic heart failure. It is well tolerated in patients, but it is not commonly prescribed for POTS. It has been also used for treatment of inappropriate sinus tachycardia with good benefit. The hypothesis for this experiment is that Ivabradine will reduce tachycardia and improve functional status in patients with POTS.
Study Details
Timeline
Interventions
Ivabradine is prescribed for treatment of chronic heart failure through inhibition of the f-channels (If) within the sinoatrial node.
A substance that has no therapeutic effect and will act as a control.