Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome
NCT ID: NCT03182725
Last Updated: 2021-06-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
37 participants
INTERVENTIONAL
2018-02-06
2020-05-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Patient will consume one placebo pill twice a day for one month.
Placebo
A substance that has no therapeutic effect and will act as a control.
Ivabradine
Patient will consume one dose of Ivabradine twice a day for one month.
Ivabradine
Ivabradine is prescribed for treatment of chronic heart failure through inhibition of the f-channels (If) within the sinoatrial node.
Interventions
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Ivabradine
Ivabradine is prescribed for treatment of chronic heart failure through inhibition of the f-channels (If) within the sinoatrial node.
Placebo
A substance that has no therapeutic effect and will act as a control.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
University of California, San Diego
OTHER
Responsible Party
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Pam Taub, MD
Associate Professor of Medicine
Principal Investigators
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Pam Taub, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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University of California, San Diego
La Jolla, California, United States
Countries
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References
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McDonald C, Frith J, Newton JL. Single centre experience of ivabradine in postural orthostatic tachycardia syndrome. Europace. 2011 Mar;13(3):427-30. doi: 10.1093/europace/euq390. Epub 2010 Nov 9.
Ewan V, Norton M, Newton JL. Symptom improvement in postural orthostatic tachycardia syndrome with the sinus node blocker ivabradine. Europace. 2007 Dec;9(12):1202. doi: 10.1093/europace/eum235. Epub 2007 Oct 19. No abstract available.
Barzilai M, Jacob G. The Effect of Ivabradine on the Heart Rate and Sympathovagal Balance in Postural Tachycardia Syndrome Patients. Rambam Maimonides Med J. 2015 Jul 30;6(3):e0028. doi: 10.5041/RMMJ.10213.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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170694
Identifier Type: -
Identifier Source: org_study_id
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