The Effect of Ivabradine on Patients With Postural Tachycardia Syndrome

• Sponsor: Tel-Aviv Sourasky Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01761825
• Collaborator: (none)
• Enrollment: 20
• Arms: 2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postural Tachycardia Syndrome	Drug: ivabradine	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• 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.
• Study Start Date: Dec 1, 2012
• Anticipated Primary Completion Date: Feb 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. the change in heart rate after the administration of Ivabradine [60 minutes , during the whole trial]

2. the change in blood pressure after the administration of Ivabradine [60 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• 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

Locations

No locations specified.

Sponsors and Collaborators

• Tel-Aviv Sourasky Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tel-Aviv Sourasky Medical Center
• ClinicalTrials.gov Identifier: NCT01761825
• Other Study ID Numbers: TASMC-12-JG-547-CTIL
• First Posted: Jan 7, 2013
• Last Update Posted: Jan 7, 2013
• Last Verified: Jan 1, 2013

• Additional relevant MeSH terms: Postural Orthostatic Tachycardia Syndrome; Tachycardia; Syndrome

Study Results

No Results Posted as of Jan 7, 2013