The Effect of Ivabradine on Patients With Postural Tachycardia Syndrome

Postural Tachycardia Syndrome Clinical Trial

Official title:

The Effect of "Funny" Channel Blocker Ivabradine on Patients With Postural Tachycardia Syndrome.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01761825
• Other study ID #: TASMC-12-JG-547-CTIL
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: November 17, 2012
• Last updated: January 3, 2013
• Start date: December 2012

Study information

• Verified date: January 2013
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postural Orthostatic Tachycardia Syndrome
• Postural Tachycardia Syndrome
• Syndrome
• Tachycardia

Intervention

Drug:
• ivabradine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change in heart rate after the administration of Ivabradine		60 minutes , during the whole trial	Yes
Primary	the change in blood pressure after the administration of Ivabradine		60 minutes	Yes