Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome (POTS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03182725|
Recruitment Status : Recruiting
First Posted : June 9, 2017
Last Update Posted : November 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Postural Orthostatic Tachycardia Syndrome||Drug: Ivabradine Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||20 patients with POTS will receive Ivabradine treatment vs placebo for one month. Then there will be a one-month wash out period prior to the cross over in which patients who received Ivabradine will receive the placebo, and patients who initially were on placebo will now receive Ivabradine.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome (a Double-blind Placebo-parallel Group Trial)|
|Anticipated Study Start Date :||January 2018|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Placebo Comparator: Placebo
Patient will consume one placebo pill per day for one month.
A substance that has no therapeutic effect and will act as a control.
Patient will consume one dose of Ivabradine per day for one month.
Ivabradine is prescribed for treatment of chronic heart failure through inhibition of the f-channels (If) within the sinoatrial node.
- Change in Heart Rate [ Time Frame: Baseline and one month ]Orthostatic heart rate monitoring will be used to gauge heart rate changes.
- Quality of Life [ Time Frame: Baseline and one month ]The Short Form-36 subjective questionnaire will be used to access quality of life.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03182725
|Contact: Adena Zadourian, B.S.||firstname.lastname@example.org|
|Contact: Pam Taub, M.D.||email@example.com|
|United States, California|
|University of California, San Diego||Recruiting|
|La Jolla, California, United States, 92093|
|Contact: Adena Zadourian, B.S. firstname.lastname@example.org|
|Principal Investigator:||Pam Taub, M.D.||University of California, San Diego|