Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome

Postural Orthostatic Tachycardia Syndrome Clinical Trial

— POTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03182725
• Other study ID #: 170694
• Status: Completed
• Phase: Phase 3
• Start date: February 6, 2018
• Est. completion date: May 8, 2020

Study information

• Verified date: June 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 8, 2020
• Est. primary completion date: May 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Postural Orthostatic Tachycardia Syndrome
• Syndrome
• Tachycardia

Intervention

Drug:
• Ivabradine
Ivabradine is prescribed for treatment of chronic heart failure through inhibition of the f-channels (If) within the sinoatrial node.
• Placebo
A substance that has no therapeutic effect and will act as a control.

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	Amgen

Country where clinical trial is conducted

United States, 

References & Publications (3)

Barzilai M, Jacob G. The Effect of Ivabradine on the Heart Rate and Sympathovagal Balance in Postural Tachycardia Syndrome Patients. Rambam Maimonides Med J. 2015 Jul 30;6(3). doi: 10.5041/RMMJ.10213. — View Citation

Ewan V, Norton M, Newton JL. Symptom improvement in postural orthostatic tachycardia syndrome with the sinus node blocker ivabradine. Europace. 2007 Dec;9(12):1202. Epub 2007 Oct 19. — View Citation

McDonald C, Frith J, Newton JL. Single centre experience of ivabradine in postural orthostatic tachycardia syndrome. Europace. 2011 Mar;13(3):427-30. doi: 10.1093/europace/euq390. Epub 2010 Nov 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Heart Rate	Orthostatic heart rate monitoring will be used to gauge heart rate changes.	Baseline and one month post-treatment
Secondary	Change in Quality of Life Via SF-36 Survey	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	Baseline and one month post-treatment