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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03182725
Recruitment Status : Active, not recruiting
First Posted : June 9, 2017
Last Update Posted : June 16, 2020
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Pam Taub, MD, University of California, San Diego

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Postural Orthostatic Tachycardia Syndrome Drug: Ivabradine Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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)
Actual Study Start Date : February 6, 2018
Actual Primary Completion Date : May 8, 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ivabradine

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Patient will consume one placebo pill twice a 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 twice a 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Change in Quality of Life [ Time Frame: Baseline and one month post-treatment ]
    The Short Form-36 subjective questionnaire will be used to access quality of life.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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


Locations
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United States, California
University of California, San Diego
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Amgen
Investigators
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Principal Investigator: Pam Taub, M.D. University of California, San Diego
More Information
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Publications of Results:

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Responsible Party: Pam Taub, MD, Associate Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03182725    
Other Study ID Numbers: 170694
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020

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