The Effect of Ivabradine on Patients With Postural Tachycardia Syndrome

January 3, 2013 updated by: Tel-Aviv Sourasky Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Active Comparator: Ivabradine
Ivabradine 10 mg once
Drug: ivabradine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the change in heart rate after the administration of Ivabradine
Time Frame: 60 minutes , during the whole trial
60 minutes , during the whole trial
the change in blood pressure after the administration of Ivabradine
Time Frame: 60 minutes
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

February 1, 2013

Study Registration Dates

First Submitted

November 17, 2012

First Submitted That Met QC Criteria

January 3, 2013

First Posted (Estimate)

January 7, 2013

Study Record Updates

Last Update Posted (Estimate)

January 7, 2013

Last Update Submitted That Met QC Criteria

January 3, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC-12-JG-547-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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