Trial · NCT02862600
Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure
NCT02862600, Phase 2, Terminated, Heart Metabolics Limited; results first posted 2017-08-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure. Trials, record NCT02862600. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02862600
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure
- NCT number
- NCT02862600
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 35 participants, actual
- Lead sponsor
- Heart Metabolics Limited
- Conditions
- Cardiomyopathy, Hypertrophic, Cardiomyopathy, Hypertrophic, Familial
- Interventions
- Perhexiline, Use of bioanalytical assay to monitor plasma levels of perhexiline
- First posted
- 2016-08-11
- Last updated
- 2017-08-31
- Results first posted
- 2017-08-31
- Limitations and caveats
- Early termination due to lack of efficacy in the first 15 subjects completing the study. Any conclusions regarding safety or efficacy a challenging in light of the small numbers of subjects studied.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline of VO2MAX at 16 Weeks | end of Period 2 (Week 16) | At the conclusion of 16 weeks of perhexiline treatment, MVO2 was measured using CPEX and compared to MVO2 measured at baseline. |
| Secondary | Change From Baseline of VO2MAX at End of Period 1 | end of Period 1 (Week 8) | At the conclusion of 8 weeks of perhexiline treatment, MVO2 was measured using CPEX and compared to MVO2 measured at baseline. |
| Secondary | Change From Baseline in the Six-minute Walk Test at the End of Period 2 | end of Period 2 (Week 16) | At the conclusion of 16 weeks of perhexiline treatment, 6MWD was measured and compared to 6MWD measured at baseline. |
| Secondary | Change From Baseline in the Six-minute Walk Test at the End of Period 1 | end of Period 1 (Week 8) | At the conclusion of 8 weeks of perhexiline treatment, 6MWD was measured and compared to 6MWD measured at baseline. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline of VO2MAX at 16 Weeks | end of Period 2 (Week 16) | ml/kg/min | MEAN | |
| SECONDARY | Change From Baseline of VO2MAX at End of Period 1 | end of Period 1 (Week 8) | ml/kg/min | MEAN | |
| SECONDARY | Change From Baseline in the Six-minute Walk Test at the End of Period 2 | end of Period 2 (Week 16) | meters | MEAN | |
| SECONDARY | Change From Baseline in the Six-minute Walk Test at the End of Period 1 | end of Period 1 (Week 8) | meters | 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 From Baseline of VO2MAX at 16 Weeks | Perhexiline--16 Weeks | -0.2 | Standard Deviation 2.7 | ml/kg/min | |
| Change From Baseline of VO2MAX at End of Period 1 | Perhexiline--8 Weeks | 0.3 | Standard Deviation 1.8 | ml/kg/min | |
| Change From Baseline in the Six-minute Walk Test at the End of Period 2 | Perhexiline--16 Weeks | 27 | Standard Deviation 46 | meters | |
| Change From Baseline in the Six-minute Walk Test at the End of Period 1 | Perhexiline--8 Weeks | 16 | Standard Deviation 50 | meters |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1--Perhexiline-low Target Range | STARTED | Perhexiline | 35 | |
| Period 1--Perhexiline-low Target Range | COMPLETED | Perhexiline | 22 | |
| Period 1--Perhexiline-low Target Range | NOT COMPLETED | Perhexiline | 13 | |
| Period 2--Perhexiline-high Target Range | STARTED | Perhexiline | 22 | |
| Period 2--Perhexiline-high Target Range | COMPLETED | Perhexiline | 15 | |
| Period 2--Perhexiline-high Target Range | NOT COMPLETED | Perhexiline | 7 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Perhexiline | 4 | 35 | |
| other | Nausea | Gastrointestinal disorders | Perhexiline | 3 | 35 | |
| other | Influenza like illness | General disorders | Perhexiline | 3 | 35 | |
| other | Nasopharyngitis | Infections and infestations | Perhexiline | 3 | 35 | |
| other | Dizziness | Nervous system disorders | Perhexiline | 2 | 35 | |
| other | Headache | Nervous system disorders | Perhexiline | 2 | 35 | |
| other | Insomnia | Psychiatric disorders | Perhexiline | 3 | 35 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Perhexiline | 2 | 35 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Perhexiline | 2 | 35 | |
| serious | Non-cardiac chest pain | Musculoskeletal and connective tissue disorders | Perhexiline | 1 | 35 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Perhexiline | 0 | 35 |
| Total, other adverse events | Perhexiline | 19 | 35 |
| Total, serious adverse events | Perhexiline | 5 | 35 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02862600
GET https://conductscience.org/api/trials/v1/NCT02862600/registered