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The Effect of Ivabradine on Patients With Postural Tachycardia Syndrome

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01761825
First Posted: January 7, 2013
Last Update Posted: January 7, 2013
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.
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
November 17, 2012
January 7, 2013
January 7, 2013
December 2012
February 2013   (Final data collection date for primary outcome measure)
  • the change in heart rate after the administration of Ivabradine [ Time Frame: 60 minutes , during the whole trial ]
  • the change in blood pressure after the administration of Ivabradine [ Time Frame: 60 minutes ]
Same as current
No Changes Posted
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The Effect of Ivabradine on Patients With Postural Tachycardia Syndrome
The Effect of "Funny" Channel Blocker Ivabradine on Patients With Postural Tachycardia Syndrome.
The purpose of this study is to determine whether Ivabradine is an effective treatment for postural tachycardia syndrome.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Postural Tachycardia Syndrome
Drug: ivabradine
  • Active Comparator: Ivabradine
    Ivabradine 10 mg once
    Intervention: Drug: ivabradine
  • Placebo Comparator: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
20
Not Provided
February 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01761825
TASMC-12-JG-547-CTIL
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Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
Not Provided
Not Provided
Tel-Aviv Sourasky Medical Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP