The Effect of Ivabradine on Patients With Postural Tachycardia Syndrome

Tel Aviv Sourasky Medical Center

Status and phase: Unknown; Phase 2

Conditions: Postural Tachycardia Syndrome

Treatments: Drug: ivabradine

Study type: Interventional

Funder types: Other

Identifiers

NCT01761825

TASMC-12-JG-547-CTIL

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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:

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  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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Ivabradine

Active Comparator group

Description:

Ivabradine 10 mg once

Treatment:

Drug: ivabradine

placebo

Placebo Comparator group