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Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome (POTS)

This study is currently recruiting participants.
Verified November 2017 by Pam Taub, MD, University of California, San Diego
Sponsor:
ClinicalTrials.gov Identifier:
NCT03182725
First Posted: June 9, 2017
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Amgen
Information provided by (Responsible Party):
Pam Taub, MD, University of California, San Diego
  Purpose
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.

Condition Intervention Phase
Postural Orthostatic Tachycardia Syndrome Drug: Ivabradine Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
20 patients with POTS will receive Ivabradine treatment vs placebo for one month. Then there will be a one-month wash out period prior to the cross over in which patients who received Ivabradine will receive the placebo, and patients who initially were on placebo will now receive Ivabradine.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome (a Double-blind Placebo-parallel Group Trial)

Resource links provided by NLM:


Further study details as provided by Pam Taub, MD, University of California, San Diego:

Primary Outcome Measures:
  • Change in Heart Rate [ Time Frame: Baseline and one month ]
    Orthostatic heart rate monitoring will be used to gauge heart rate changes.


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: Baseline and one month ]
    The Short Form-36 subjective questionnaire will be used to access quality of life.


Estimated Enrollment: 20
Anticipated Study Start Date: January 2018
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Patient will consume one placebo pill per day for one month.
Drug: Placebo
A substance that has no therapeutic effect and will act as a control.
Experimental: Ivabradine
Patient will consume one dose of Ivabradine per day for one month.
Drug: Ivabradine
Ivabradine is prescribed for treatment of chronic heart failure through inhibition of the f-channels (If) within the sinoatrial node.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects aged 18-45.
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03182725


Contacts
Contact: Adena Zadourian, B.S. 858-246-2510 ucsdresearchcoordinator@gmail.com
Contact: Pam Taub, M.D. ptaub@ucsd.edu

Locations
United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Adena Zadourian, B.S.       azadourian@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
Amgen
Investigators
Principal Investigator: Pam Taub, M.D. University of California, San Diego
  More Information

Publications:
Responsible Party: Pam Taub, MD, Associate Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03182725     History of Changes
Other Study ID Numbers: 170694
First Submitted: June 7, 2017
First Posted: June 9, 2017
Last Update Posted: November 8, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pam Taub, MD, University of California, San Diego:
POTS
tachycardia
ivabradine

Additional relevant MeSH terms:
Syndrome
Tachycardia
Postural Orthostatic Tachycardia Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases