NCT03182725: POTS

Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome

Completed Phase 3 Results posted Last updated 29 June 2021

What this trial tests

Phase 3 trial testing Ivabradine in Postural Orthostatic Tachycardia Syndrome in 37 participants. Completed in 8 May 2020.

Timeline

6 February 2018

Primary endpoint
8 May 2020

8 May 2020

Quick facts

Lead sponsor	University of California, San Diego
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	37
Start date	6 February 2018
Primary completion	8 May 2020
Estimated completion	8 May 2020
Sites	1 location across United States

Drugs / interventions tested

• Ivabradine (IVABRADINE) — full drug profile →
• Placebo

Conditions studied

• Postural Orthostatic Tachycardia Syndrome — all drugs for Postural Orthostatic Tachycardia Syndrome →

Sponsor

University of California, San Diego

Who can join

Adults 18 to 65, any sex, with Postural Orthostatic Tachycardia Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Heart Rate Primary · Baseline and one month post-treatment

Orthostatic heart rate monitoring will be used to gauge heart rate changes.

Group	Value	95% CI
Placebo	17.0	± 10.4
Ivabradine	13.1	± 8.6

Change in Quality of Life Via SF-36 Survey Secondary · Baseline and one month post-treatment

Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) The SF-36 has 36 questions and is an indicator of overall health status and is well-validated. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. The total score on the SF-36 ranges from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality Physical functioning Bodily pain General health perceptions Physical role functioning Emotional role functioning Social role functioning Mental health

Group	Value	95% CI
Placebo	44.1	± 22.4
Ivabradine	53.4	± 27

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Autonomic Dysfunction in Cardiology: Pathophysiology, Investigation, and Management.
   Arnold AC, Ng J, Lei L, Raj SR. · · 2017 · cited 23× · PMID 29102451 · DOI 10.1016/j.cjca.2017.09.008