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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Postural Orthostatic Tachycardia Syndrome
Interventions Drug: Ivabradine
Drug: Placebo
Enrollment 37
Recruitment Details  
Pre-assignment Details 10 participants signed the consent form but did not pass the screening assessments. 1 participant signed the consent form and then withdrew prior to randomization.
Arm/Group Title Placebo in Arm A, Ivabradine in Arm B Ivabradine in Arm A, Placebo in Arm B
Hide Arm/Group Description

In the first Arm, Patient will consume one placebo pill twice a day for one month. After the first arm, there will be a one-week washout. After washout, the patient will commence Arm B where they consume ne dose of ivabradine twice a day for one month.

Placebo: A substance that has no therapeutic effect and will act as a control.

In the second arm, 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.

Patient will consume one dose of Ivabradine twice a day for one month. In the first Arm, Patient will consume one dose of ivabradine twice a day for one month. After the first arm, there will be a one-week washout. After washout, the patient will commence Arm B where they consume one placebo pill twice a day for one month

Placebo: A substance that has no therapeutic effect and will act as a control.

In the second arm, 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.

Period Title: Treatment Arm 1 (First Half of Study)
Started 16 10
Completed 16 7
Not Completed 0 3
Period Title: Treatment Arm 2 (Second Half of Study)
Started 16 6 [1]
Completed 16 6
Not Completed 0 0
[1]
One participant withdrew during crossover and therefore did not start Treatment Arm 2.
Arm/Group Title Placebo in Arm A, Ivabradine in Arm B Ivabradine in Arm A, Placebo in Arm B Total
Hide Arm/Group Description

In the first Arm, 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.

In the second arm, 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.

In the first arm of the study, 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.

In the second arm, 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.

Total of all reporting groups
Overall Number of Baseline Participants 16 10 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 10 participants 26 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
 100.0%
10
 100.0%
26
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 10 participants 26 participants
35.75  (10.7) 27.8  (11.15) 34.8  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 10 participants 26 participants
Female
15
  93.8%
10
 100.0%
25
  96.2%
Male
1
   6.3%
0
   0.0%
1
   3.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 10 participants 26 participants
Hispanic or Latino
1
   6.3%
0
   0.0%
1
   3.8%
Not Hispanic or Latino
15
  93.8%
10
 100.0%
25
  96.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 10 participants 26 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
13
  81.3%
10
 100.0%
23
  88.5%
More than one race
2
  12.5%
0
   0.0%
2
   7.7%
Unknown or Not Reported
1
   6.3%
0
   0.0%
1
   3.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 10 participants 26 participants
16 10 26
1.Primary Outcome
Title Change in Heart Rate
Hide Description Orthostatic heart rate monitoring will be used to gauge heart rate changes.
Time Frame Baseline and one month post-treatment
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Hide Analysis Population Description
In total, 22 patients with hyperadrenergic POTS as the predominant subtype completed a randomized, double-blinded, placebo-controlled, crossover trial with ivabradine. Patients were randomized to start either ivabradine or placebo for 1 month, and then were crossed over to the other treatment for 1 month. Heart rate, QOL, and plasma NE levels were measured at baseline and at the end of each treatment month.
Arm/Group Title Placebo Ivabradine
Hide Arm/Group Description:

In the first Arm, 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.

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.

Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: beats per minute
17.0  (10.4) 13.1  (8.6)
2.Secondary Outcome
Title Change in Quality of Life Via SF-36 Survey
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Ivabradine
Hide Arm/Group Description:

In the first Arm, 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.

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.

Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
44.1  (22.4) 53.4  (27)
Time Frame 3 months
Adverse Event Reporting Description Adverse events were monitored in all enrolled participants over a period of 3 months.
 
Arm/Group Title Placebo Ivabradine
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Placebo Ivabradine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/37 (0.00%) 
Hide Serious Adverse Events
Placebo Ivabradine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/37 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Ivabradine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/37 (0.00%) 
  • smaller sample size
  • many patients suspected they were on ivabradine
  • patients were only on 1 month of ivabradine; longer study duration may be warranted to assess potential long term effects
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Pam Taub
Organization: University of California - San Diego Health
Phone: 858-246-2342
EMail: ptaub@health.ucsd.edu
Layout table for additonal information
Responsible Party: Pam Taub, MD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03182725    
Other Study ID Numbers: 170694
First Submitted: June 7, 2017
First Posted: June 9, 2017
Results First Submitted: April 20, 2021
Results First Posted: June 29, 2021
Last Update Posted: June 29, 2021