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The Effect of Ivabradine on Patients With Postural Tachycardia Syndrome

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. Identifier: NCT01761825
Recruitment Status : Unknown
Verified January 2013 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : January 7, 2013
Last Update Posted : January 7, 2013
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Brief Summary:
The purpose of this study is to determine whether Ivabradine is an effective treatment for postural tachycardia syndrome.

Condition or disease Intervention/treatment Phase
Postural Tachycardia Syndrome Drug: ivabradine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of "Funny" Channel Blocker Ivabradine on Patients With Postural Tachycardia Syndrome.
Study Start Date : December 2012
Estimated Primary Completion Date : February 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ivabradine

Arm Intervention/treatment
Active Comparator: Ivabradine
Ivabradine 10 mg once
Drug: ivabradine
Placebo Comparator: placebo

Primary Outcome Measures :
  1. the change in heart rate after the administration of Ivabradine [ Time Frame: 60 minutes , during the whole trial ]
  2. the change in blood pressure after the administration of Ivabradine [ Time Frame: 60 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients diagnosed with POTS by the following criteria:

    1. The presence of characteristic orthostatic symptoms of the POTS for at least six months.
    2. An increase in the heart rate of at least 30 beats per minute (without concomitant significant decrease in blood pressure of more than 20/10 mmHg) within 10 minutes after assuming a standing position (or during tilt test) on at least 3 separate occasions.
    3. No other concomitant diseases that could explain the symptoms of POTS.

      Exclusion Criteria:

    1. History of systemic illness capable of affecting of affecting autonomic function (eg, diabetes mellitus, SLE).
    2. History of cardiovascular disease.
    3. History of smoking, drug or alcohol abuse.
    4. Pregnancy, and also uncontrolled thyroid or adrenal disorders.
    5. Using any drug metabolized by cytochrome P450 3A4 enzyme during the last 72 hours.
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Responsible Party: Tel-Aviv Sourasky Medical Center Identifier: NCT01761825    
Other Study ID Numbers: TASMC-12-JG-547-CTIL
First Posted: January 7, 2013    Key Record Dates
Last Update Posted: January 7, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
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Postural Orthostatic Tachycardia Syndrome
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases