Skip to main content
OpenTrials
Completed

NCT Number: NCT03182725

Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postural Orthostatic Tachycardia Syndrome Arrhythmias, Cardiac Autonomic Nervous System Diseases Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Nervous System Diseases Orthostatic Intolerance Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Dysautonomias Tachycardia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of California, San Diego

La Jolla, California, 92093, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects aged 18-65.
  • Subjects must have POTS diagnosis (Hyperadrenergic Subtype with NE> 600pg/ml))
  • Subjects with no structural heart disease
  • Subject with no arrhythmias
  • Subjects with norepinephrine levels greater than 600 pg/ml
  • Subjects with normal CBC, Metabolic, and thyroid levels

Exclusion criteria

  • Thyroid or adrenal disorders
  • Drugs that interfere with Ivabradine (example: Cytochrome P450 drugs)
  • Presentation of peripheral edema and discolored toes with peripheral autonomic neuropathy. Symptoms include: legs (reduced hair growth, cramps), toes (blue color), legs/feet (wounds, ulcers that do not heal), and muscles (numbness, heaviness)
  • Subjects who have had a history of systemic illnesses (acute or chronic infectious); autoimmune/ inflammatory disease, cancer, COPD, anemia, diabetes, or psychiatric illness
  • Subjects with resting heart rate< 60beats/min, atrial fibrillation, advanced AV blocks, sinus disease, and acute decompensated heart failure and severe hepatic impairment.
  • Smokers or alcohol abuse
  • Pregnant or breastfeeding mothers
  • Woman of childbearing potential who are unwilling to use highly effective contraception during treatment and for an additional one month after discontinuing the study drug

Treatment and study plan

Ivabradine

Drug

Ivabradine is prescribed for treatment of chronic heart failure through inhibition of the f-channels (If) within the sinoatrial node.

Placebo

Drug

A substance that has no therapeutic effect and will act as a control.

Primary outcomes

  1. Change in Heart Rate

    Time frame: Baseline and one month post-treatment

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

Secondary outcomes

  1. Change in Quality of Life Via SF-36 Survey

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Amgen

Registry information

Official study title

Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome (a Double-blind Placebo-parallel Group Trial)

Acronym: POTS

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 9, 2017
Registry last updated
Jun 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.