Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome (POTS)
Primary Purpose
Postural Orthostatic Tachycardia Syndrome
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ivabradine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postural Orthostatic Tachycardia Syndrome focused on measuring POTS, tachycardia, ivabradine
Eligibility Criteria
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
Sites / Locations
- University of California, San Diego
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Ivabradine
Arm Description
Patient will consume one placebo pill twice a day for one month.
Patient will consume one dose of Ivabradine twice a day for one month.
Outcomes
Primary Outcome Measures
Change in Heart Rate
Orthostatic heart rate monitoring will be used to gauge heart rate changes.
Secondary Outcome Measures
Change in Quality of Life Via SF-36 Survey
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
Full Information
NCT ID
NCT03182725
First Posted
June 7, 2017
Last Updated
June 8, 2021
Sponsor
University of California, San Diego
Collaborators
Amgen
1. Study Identification
Unique Protocol Identification Number
NCT03182725
Brief Title
Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome
Acronym
POTS
Official Title
Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome (a Double-blind Placebo-parallel Group Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
February 6, 2018 (Actual)
Primary Completion Date
May 8, 2020 (Actual)
Study Completion Date
May 8, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
Amgen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Postural orthostatic tachycardia syndrome (POTS) occurs in approximately 500,000 Americans, but predominates in women with a 5:1 ratio. Patients with POTS experience debilitating tachycardia upon postural changes such as standing that impairs their quality of life. Tachycardia is clinically defined as a heart rate greater than 100 beats/min; and in POTS patients, the prolonged heart rate increase is greater than 30 beats/min or increases to 120 beats/min within the first ten minutes of a diagnostic tilt table test without postural hypotension. There are currently no effective treatment methods for POTS. However, several studies suggest Ivabradine could be a main treatment option for POTS because Ivabradine specifically inhibits the f-channels (If) within the sinoatrial (SA) node, which slows the heart rate. Currently in the US, Ivabradine is mainly prescribed to treat chronic heart failure. It is well tolerated in patients, but it is not commonly prescribed for POTS. It has been also used for treatment of inappropriate sinus tachycardia with good benefit. The hypothesis for this experiment is that Ivabradine will reduce tachycardia and improve functional status in patients with POTS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postural Orthostatic Tachycardia Syndrome
Keywords
POTS, tachycardia, ivabradine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patient will consume one placebo pill twice a day for one month.
Arm Title
Ivabradine
Arm Type
Experimental
Arm Description
Patient will consume one dose of Ivabradine twice a day for one month.
Intervention Type
Drug
Intervention Name(s)
Ivabradine
Intervention Description
Ivabradine is prescribed for treatment of chronic heart failure through inhibition of the f-channels (If) within the sinoatrial node.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A substance that has no therapeutic effect and will act as a control.
Primary Outcome Measure Information:
Title
Change in Heart Rate
Description
Orthostatic heart rate monitoring will be used to gauge heart rate changes.
Time Frame
Baseline and one month post-treatment
Secondary Outcome Measure Information:
Title
Change in Quality of Life Via SF-36 Survey
Description
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
Time Frame
Baseline and one month post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pam Taub, M.D.
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21062792
Citation
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.
Results Reference
result
PubMed Identifier
17951266
Citation
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.
Results Reference
result
PubMed Identifier
26241226
Citation
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.
Results Reference
result
Learn more about this trial
Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome
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