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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
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center Identifier:
First received: November 17, 2012
Last updated: January 3, 2013
Last verified: January 2013
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
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.

Resource links provided by NLM:

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 ]
  • the change in blood pressure after the administration of Ivabradine [ Time Frame: 60 minutes ]

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


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Tel-Aviv Sourasky Medical Center 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

Additional relevant MeSH terms:
Postural Orthostatic Tachycardia Syndrome
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases processed this record on September 21, 2017