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
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Condition or disease | Intervention/treatment | Phase |
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Postural Orthostatic Tachycardia Syndrome | Drug: Ivabradine Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 37 participants |
Allocation: | Randomized |
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) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Patient will consume one placebo pill twice a day for one month.
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Drug: Placebo
A substance that has no therapeutic effect and will act as a control. |
Experimental: Ivabradine
Patient will consume one dose of Ivabradine twice a day for one month.
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Drug: Ivabradine
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
Sections:
Vitality Physical functioning Bodily pain General health perceptions Physical role functioning Emotional role functioning Social role functioning Mental health

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects aged 18-65.
- Subjects must have POTS diagnosis (Hyperadrenergic Subtype with NE> 600pg/ml))
- Subjects with no structural heart disease
- Subject with no arrhythmias
- Subjects with norepinephrine levels greater than 600 pg/ml
- Subjects with normal CBC, Metabolic, and thyroid levels
Exclusion Criteria:
- Thyroid or adrenal disorders
- Drugs that interfere with Ivabradine (example: Cytochrome P450 drugs)
- Presentation of peripheral edema and discolored toes with peripheral autonomic neuropathy. Symptoms include: legs (reduced hair growth, cramps), toes (blue color), legs/feet (wounds, ulcers that do not heal), and muscles (numbness, heaviness)
- Subjects who have had a history of systemic illnesses (acute or chronic infectious); autoimmune/ inflammatory disease, cancer, COPD, anemia, diabetes, or psychiatric illness
- Subjects with resting heart rate< 60beats/min, atrial fibrillation, advanced AV blocks, sinus disease, and acute decompensated heart failure and severe hepatic impairment.
- Smokers or alcohol abuse
- Pregnant or breastfeeding mothers
- Woman of childbearing potential who are unwilling to use highly effective contraception during treatment and for an additional one month after discontinuing the study drug

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 |
Documents provided by Pam Taub, MD, University of California, San Diego:
Responsible Party: | Pam Taub, MD, Associate Professor of Medicine, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT03182725 |
Other Study ID Numbers: |
170694 |
First Posted: | June 9, 2017 Key Record Dates |
Results First Posted: | June 29, 2021 |
Last Update Posted: | June 29, 2021 |
Last Verified: | June 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
POTS tachycardia ivabradine |
Postural Orthostatic Tachycardia Syndrome Tachycardia Syndrome Disease Pathologic Processes Arrhythmias, Cardiac Heart Diseases |
Cardiovascular Diseases Cardiac Conduction System Disease Orthostatic Intolerance Primary Dysautonomias Autonomic Nervous System Diseases Nervous System Diseases |