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The Effect of Ivabradine on Patients With Postural Tachycardia Syndrome

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01761825
First received: November 17, 2012
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Postural Tachycardia Syndrome
 Drug: ivabradine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of "Funny" Channel Blocker Ivabradine on Patients With Postural Tachycardia Syndrome.

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • the change in heart rate after the administration of Ivabradine [ Time Frame: 60 minutes , during the whole trial ] [ Designated as safety issue: Yes ]
  • the change in blood pressure after the administration of Ivabradine [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: December 2012
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ivabradine
Ivabradine 10 mg once
 Drug: ivabradine
Placebo Comparator: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01761825     History of Changes
Other Study ID Numbers: TASMC-12-JG-547-CTIL
Study First Received: November 17, 2012
Last Updated: January 3, 2013
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on June 17, 2013