Trial Outcomes & Findings for Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome (NCT NCT03182725)
NCT ID: NCT03182725
Last Updated: 2021-06-29
Results Overview
Orthostatic heart rate monitoring will be used to gauge heart rate changes.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
37 participants
Primary outcome timeframe
Baseline and one month post-treatment
Results posted on
2021-06-29
Participant Flow
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.
Participant milestones
| Measure |
Placebo in Arm A, Ivabradine in Arm B
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.
|
Ivabradine in Arm A, Placebo in Arm B
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.
|
|---|---|---|
|
Treatment Arm 1 (First Half of Study)
STARTED
|
16
|
10
|
|
Treatment Arm 1 (First Half of Study)
COMPLETED
|
16
|
7
|
|
Treatment Arm 1 (First Half of Study)
NOT COMPLETED
|
0
|
3
|
|
Treatment Arm 2 (Second Half of Study)
STARTED
|
16
|
6
|
|
Treatment Arm 2 (Second Half of Study)
COMPLETED
|
16
|
6
|
|
Treatment Arm 2 (Second Half of Study)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome
Baseline characteristics by cohort
| Measure |
Placebo in Arm A, Ivabradine in Arm B
n=16 Participants
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.
|
Ivabradine in Arm A, Placebo in Arm B
n=10 Participants
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
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
35.75 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
27.8 years
STANDARD_DEVIATION 11.15 • n=7 Participants
|
34.8 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
10 participants
n=7 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and one month post-treatmentPopulation: 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.
Orthostatic heart rate monitoring will be used to gauge heart rate changes.
Outcome measures
| Measure |
Placebo
n=22 Participants
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.
|
Ivabradine
n=22 Participants
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.
|
|---|---|---|
|
Change in Heart Rate
|
17.0 beats per minute
Standard Deviation 10.4
|
13.1 beats per minute
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: Baseline and one month post-treatmentMedical 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
Outcome measures
| Measure |
Placebo
n=22 Participants
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.
|
Ivabradine
n=22 Participants
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.
|
|---|---|---|
|
Change in Quality of Life Via SF-36 Survey
|
44.1 units on a scale
Standard Deviation 22.4
|
53.4 units on a scale
Standard Deviation 27
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ivabradine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Pam Taub
University of California - San Diego Health
Phone: 858-246-2342
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place