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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
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Pam Taub, MD, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE June 7, 2017
First Posted Date  ICMJE June 9, 2017
Results First Submitted Date  ICMJE April 20, 2021
Results First Posted Date  ICMJE June 29, 2021
Last Update Posted Date June 29, 2021
Actual Study Start Date  ICMJE February 6, 2018
Actual Primary Completion Date May 8, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2018)
Change in Heart Rate [ Time Frame: Baseline and one month post-treatment ]
Orthostatic heart rate monitoring will be used to gauge heart rate changes.
Original Primary Outcome Measures  ICMJE
 (submitted: June 7, 2017)
Change in Heart Rate [ Time Frame: Baseline and one month ]
Orthostatic heart rate monitoring will be used to gauge heart rate changes.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2021)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2017)
Quality of Life [ Time Frame: Baseline and one month ]
The QOL questionnaire will be used to access quality of life.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome
Official Title  ICMJE Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome (a Double-blind Placebo-parallel Group Trial)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Postural Orthostatic Tachycardia Syndrome
Intervention  ICMJE
  • Drug: Ivabradine
    Ivabradine is prescribed for treatment of chronic heart failure through inhibition of the f-channels (If) within the sinoatrial node.
  • Drug: Placebo
    A substance that has no therapeutic effect and will act as a control.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Patient will consume one placebo pill twice a day for one month.
    Intervention: Drug: Placebo
  • Experimental: Ivabradine
    Patient will consume one dose of Ivabradine twice a day for one month.
    Intervention: Drug: Ivabradine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 13, 2021)
37
Original Estimated Enrollment  ICMJE
 (submitted: June 7, 2017)
20
Actual Study Completion Date  ICMJE May 8, 2020
Actual Primary Completion Date May 8, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03182725
Other Study ID Numbers  ICMJE 170694
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pam Taub, MD, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE Amgen
Investigators  ICMJE
Principal Investigator: Pam Taub, M.D. University of California, San Diego
PRS Account University of California, San Diego
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP