Trial · NCT03182725
Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome
NCT03182725, Phase 3, Completed, University of California, San Diego; results first posted 2021-06-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome. Trials, record NCT03182725. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03182725
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome
- NCT number
- NCT03182725
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 37 participants, actual
- Lead sponsor
- University of California, San Diego
- Conditions
- Postural Orthostatic Tachycardia Syndrome
- Interventions
- Ivabradine, Placebo
- First posted
- 2017-06-09
- Last updated
- 2021-06-29
- Results first posted
- 2021-06-29
- Limitations and caveats
- * 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
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Heart Rate | Baseline and one month post-treatment | Orthostatic heart rate monitoring will be used to gauge heart rate changes. |
| Secondary | Change in Quality of Life Via SF-36 Survey | 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 |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Heart Rate | Baseline and one month post-treatment | 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. | beats per minute | MEAN |
| SECONDARY | Change in Quality of Life Via SF-36 Survey | Baseline and one month post-treatment | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Heart Rate | Placebo | 17.0 | Standard Deviation 10.4 | beats per minute | |
| Change in Heart Rate | Ivabradine | 13.1 | Standard Deviation 8.6 | beats per minute | |
| Change in Quality of Life Via SF-36 Survey | Placebo | 44.1 | Standard Deviation 22.4 | units on a scale | |
| Change in Quality of Life Via SF-36 Survey | Ivabradine | 53.4 | Standard Deviation 27 | units on a scale |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Arm 1 (First Half of Study) | STARTED | Placebo in Arm A, Ivabradine in Arm B | 16 | |
| Treatment Arm 1 (First Half of Study) | STARTED | Ivabradine in Arm A, Placebo in Arm B | 10 | |
| Treatment Arm 1 (First Half of Study) | COMPLETED | Placebo in Arm A, Ivabradine in Arm B | 16 | |
| Treatment Arm 1 (First Half of Study) | COMPLETED | Ivabradine in Arm A, Placebo in Arm B | 7 | |
| Treatment Arm 1 (First Half of Study) | NOT COMPLETED | Placebo in Arm A, Ivabradine in Arm B | 0 | |
| Treatment Arm 1 (First Half of Study) | NOT COMPLETED | Ivabradine in Arm A, Placebo in Arm B | 3 | |
| Treatment Arm 2 (Second Half of Study) | STARTED | Placebo in Arm A, Ivabradine in Arm B | 16 | |
| Treatment Arm 2 (Second Half of Study) | STARTED | Ivabradine in Arm A, Placebo in Arm B | 6 | |
| Treatment Arm 2 (Second Half of Study) | COMPLETED | Placebo in Arm A, Ivabradine in Arm B | 16 | |
| Treatment Arm 2 (Second Half of Study) | COMPLETED | Ivabradine in Arm A, Placebo in Arm B | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 37 |
| Total, all-cause mortality | Ivabradine | 0 | 37 |
| Total, other adverse events | Placebo | 0 | 37 |
| Total, other adverse events | Ivabradine | 0 | 37 |
| Total, serious adverse events | Placebo | 0 | 37 |
| Total, serious adverse events | Ivabradine | 0 | 37 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ivabradine vs Placebo: deaths from any cause | Trial comparisons |
| Ivabradine vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03182725
GET https://conductscience.org/api/trials/v1/NCT03182725/registered