Back to resultsThe Effect of Ivabradine on Patients With Postural Tachycardia Syndrome
Primary Purpose
Postural Tachycardia Syndrome
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ivabradine
Sponsored by
About this trial
This is an interventional treatment trial for Postural Tachycardia Syndrome
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with POTS by the following criteria:
- The presence of characteristic orthostatic symptoms of the POTS for at least six months.
- 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.
No other concomitant diseases that could explain the symptoms of POTS.
Exclusion Criteria:
- History of systemic illness capable of affecting of affecting autonomic function (eg, diabetes mellitus, SLE).
- History of cardiovascular disease.
- History of smoking, drug or alcohol abuse.
- Pregnancy, and also uncontrolled thyroid or adrenal disorders.
- Using any drug metabolized by cytochrome P450 3A4 enzyme during the last 72 hours.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ivabradine
placebo
Arm Description
Ivabradine 10 mg once
Outcomes
Primary Outcome Measures
the change in heart rate after the administration of Ivabradine
the change in blood pressure after the administration of Ivabradine
Secondary Outcome Measures
Full Information
NCT ID
NCT01761825
First Posted
November 17, 2012
Last Updated
January 3, 2013
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01761825
Brief Title
The Effect of Ivabradine on Patients With Postural Tachycardia Syndrome
Official Title
The Effect of "Funny" Channel Blocker Ivabradine on Patients With Postural Tachycardia Syndrome.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether Ivabradine is an effective treatment for postural tachycardia syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postural Tachycardia Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ivabradine
Arm Type
Active Comparator
Arm Description
Ivabradine 10 mg once
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ivabradine
Primary Outcome Measure Information:
Title
the change in heart rate after the administration of Ivabradine
Time Frame
60 minutes , during the whole trial
Title
the change in blood pressure after the administration of Ivabradine
Time Frame
60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with POTS by the following criteria:
The presence of characteristic orthostatic symptoms of the POTS for at least six months.
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.
No other concomitant diseases that could explain the symptoms of POTS.
Exclusion Criteria:
History of systemic illness capable of affecting of affecting autonomic function (eg, diabetes mellitus, SLE).
History of cardiovascular disease.
History of smoking, drug or alcohol abuse.
Pregnancy, and also uncontrolled thyroid or adrenal disorders.
Using any drug metabolized by cytochrome P450 3A4 enzyme during the last 72 hours.
12. IPD Sharing Statement
Learn more about this trial
The Effect of Ivabradine on Patients With Postural Tachycardia Syndrome
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