Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome (POTS)
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|ClinicalTrials.gov Identifier: NCT03182725|
Recruitment Status : Completed
First Posted : June 9, 2017
Results First Posted : June 29, 2021
Last Update Posted : June 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Postural Orthostatic Tachycardia Syndrome||Drug: Ivabradine Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 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)|
|Actual Study Start Date :||February 6, 2018|
|Actual Primary Completion Date :||May 8, 2020|
|Actual Study Completion Date :||May 8, 2020|
Placebo Comparator: Placebo
Patient will consume one placebo pill twice a day for one month.
A substance that has no therapeutic effect and will act as a control.
Patient will consume one dose of Ivabradine twice a 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 post-treatment ]Orthostatic heart rate monitoring will be used to gauge heart rate changes.
- Change in Quality of Life Via SF-36 Survey [ Time Frame: Baseline and one month post-treatment ]
Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) The SF-36 has 36 questions and is an indicator of overall health status and is well-validated. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. The total score on the SF-36 ranges from 0 - 100 Lower scores = more disability, higher scores = less disability
Vitality Physical functioning Bodily pain General health perceptions Physical role functioning Emotional role functioning Social role functioning Mental health
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
|United States, California|
|University of California, San Diego|
|La Jolla, California, United States, 92093|
|Principal Investigator:||Pam Taub, M.D.||University of California, San Diego|