Trial · NCT02310672
REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension
NCT02310672, Phase 4, Completed, Actelion; results first posted 2020-09-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension. Trials, record NCT02310672. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02310672
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension
- NCT number
- NCT02310672
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 89 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Macitentan
- First posted
- 2014-12-08
- Last updated
- 2025-03-30
- Results first posted
- 2020-09-24
- Limitations and caveats
Due to the open-label non-comparative design of study, it cannot be excluded that 6MWD and WHO FC could have been influenced by participants' knowledge that they did receive an active treatment whose efficacy had already been demonstrated.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Right Ventricular Stroke Volume (RVSV) to Week 26 | Baseline and Week 26 | Change from baseline in RVSV assessed by cardiac magnetic resonance imaging (MRI) from pulmonary artery flow was reported at Week 26. Primary analysis were based on interim results as pre-planned and the primary outcome measures data table reported is finalized as is. |
| Primary | Ratio of Week 26 to Baseline Pulmonary Vascular Resistance (PVR) | Baseline and Week 26 | Ratio of Week 26 to baseline PVR as assessed by RHC was reported. PVR represents the resistance against which the right ventricle needs to pump. PVR is determined by right heart catheterization (RHC). PVR was calculated as 80\*(Mean pulmonary arterial pressure \[mPAP\] -\[Pulmonary capillary wedge pressure {PCWP} or Left ventricular end diastolic pressure {LVEDP} if PCWP not available/cardiac output \[CO\]). Primary analysis were based on interim results as pre-planned and the primary outcome measures data table reported is finalized as is. |
| Secondary | Change From Baseline in Right Ventricular End Diastolic Volume (RVEDV) to Week 26 | Baseline to Week 26 | Change from baseline to Week 26 in RVEDV assessed by cardiac MRI was reported. |
| Secondary | Change From Baseline in Right Ventricular End Systolic Volume (RVESV) to Week 26 | Baseline to Week 26 | Change from baseline to Week 26 in RVESV assessed by cardiac MRI was reported. |
| Secondary | Change From Baseline in Right Ventricular Ejection Fraction (RVEF) to Week 26 (% Blood Volume) | Baseline to Week 26 | Change from baseline to Week 26 in RVEF based on pulmonary artery flow assessed by cardiac MRI was reported. |
| Secondary | Change From Baseline in Right Ventricle (RV) Mass to Week 26 | Baseline to Week 26 | Change from baseline to Week 26 in RV mass assessed by cardiac MRI was reported. |
| Secondary | Change From Baseline in Six-minutes Walk Distance (6MWD) to Week 26 | Baseline to Week 26 | 6MWD is a non-encouraged test performed in a 30 meter (m) long flat corridor, where the participant is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. This test is used to assess exercise capacity. The test was performed about 30 minutes after study drug administration. Any increase in the walk distance was considered improvement from baseline. |
| Secondary | Change From Baseline in World Health Organization Functional Class (WHO FC) to Week 26 | Baseline to Week 26 | WHO FC is a classification which reflects disease severity based on symptoms. WHO Functional Classification of pulmonary hypertension comprises of Class I (participants with pulmonary hypertension but without resulting limitation of physical activity), II (participants with pulmonary hypertension resulting in slight limitation of physical activity), III (participants with pulmonary hypertension resulting in marked limitation of physical activity) and IV (participants with pulmonary hypertension with inability to carry out any physical activity without symptoms). Changes from baseline to Week 26 included: improvement (change from a higher to a lower FC), worsening (change from a lower to a higher FC) or unchanged/stable (same FC at baseline and at the post-baseline time point). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Right Ventricular Stroke Volume (RVSV) to Week 26 | Baseline and Week 26 | The Modified full analysis set (mFAS) included of all screened participants who received at least one dose of study drug and who had a baseline as well as a post-baseline measurement taken between 16 weeks and 30 weeks of treatment. | milliliters (mL) | LEAST_SQUARES_MEAN |
| PRIMARY | Ratio of Week 26 to Baseline Pulmonary Vascular Resistance (PVR) | Baseline and Week 26 | mFAS included of all screened participants who received at least one dose of study drug and who had a baseline as well as a post-baseline measurement taken between 16 weeks and 30 weeks of treatment. | Ratio | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Right Ventricular End Diastolic Volume (RVEDV) to Week 26 | Baseline to Week 26 | Safety set included all screened participants who received at least one dose of study drug. Here 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure. | mL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Right Ventricular End Systolic Volume (RVESV) to Week 26 | Baseline to Week 26 | Safety set included all screened participants who received at least one dose of study drug. Here 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure. | mL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Right Ventricular Ejection Fraction (RVEF) to Week 26 (% Blood Volume) | Baseline to Week 26 | Safety set included all screened participants who received at least one dose of study drug. Here 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure. | Percentage of blood volume | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Right Ventricle (RV) Mass to Week 26 | Baseline to Week 26 | Safety set included all screened participants who received at least one dose of study drug. Here 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure. | Grams | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Six-minutes Walk Distance (6MWD) to Week 26 | Baseline to Week 26 | Safety set included all screened participants who received at least one dose of study drug. Here 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure. | Meters | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in World Health Organization Functional Class (WHO FC) to Week 26 | Baseline to Week 26 | Safety Set included all screened participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Right Ventricular Stroke Volume (RVSV) to Week 26 | Macitanten 10 mg | 15.17 | Standard Error 2.75 | milliliters (mL) | |
| Ratio of Week 26 to Baseline Pulmonary Vascular Resistance (PVR) | Macitanten 10 mg | 0.63 | Geometric Coefficient of Variation 0.11 | Ratio | |
| Change From Baseline in Right Ventricular End Diastolic Volume (RVEDV) to Week 26 | Macitanten 10 mg | -6.22 | 95% Confidence Interval -12.50 to 0.07 | mL | |
| Change From Baseline in Right Ventricular End Systolic Volume (RVESV) to Week 26 | Macitanten 10 mg | -16.39 | 95% Confidence Interval -20.56 to -12.21 | mL | |
| Change From Baseline in Right Ventricular Ejection Fraction (RVEF) to Week 26 (% Blood Volume) | Macitanten 10 mg | 10.14 | 95% Confidence Interval 7.46 to 12.83 | Percentage of blood volume | |
| Change From Baseline in Right Ventricle (RV) Mass to Week 26 | Macitanten 10 mg | -10.10 | 95% Confidence Interval -13.81 to -6.39 | Grams | |
| Change From Baseline in Six-minutes Walk Distance (6MWD) to Week 26 | Macitanten 10 mg | 38.85 | Standard Error 7.37 | Meters | |
| Change From Baseline in World Health Organization Functional Class (WHO FC) to Week 26 | Macitanten 10 mg | Missing WHO FC | 5 | Participants | |
| Change From Baseline in World Health Organization Functional Class (WHO FC) to Week 26 | Macitanten 10 mg | Worsened WHO FC | 1 | Participants | |
| Change From Baseline in World Health Organization Functional Class (WHO FC) to Week 26 | Macitanten 10 mg | Unchanged WHO FC | 35 | Participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Macitentan 10 mg | 87 | |
| Overall Study | COMPLETED | Macitentan 10 mg | 72 | |
| Overall Study | NOT COMPLETED | Macitentan 10 mg | 15 |
Source ClinicalTrials.gov
Adverse events49
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 | Diarrhoea | Gastrointestinal disorders | Macitentan 10 mg | 8 | 87 | |
| other | Nausea | Gastrointestinal disorders | Macitentan 10 mg | 6 | 87 | |
| other | Oedema Peripheral | General disorders | Macitentan 10 mg | 19 | 87 | |
| other | Pyrexia | General disorders | Macitentan 10 mg | 7 | 87 | |
| other | Nasopharyngitis | Infections and infestations | Macitentan 10 mg | 6 | 87 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Macitentan 10 mg | 10 | 87 | |
| other | Haemoglobin Decreased | Investigations | Macitentan 10 mg | 10 | 87 | |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Macitentan 10 mg | 7 | 87 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Macitentan 10 mg | 9 | 87 | |
| other | Pain in Extremity | Musculoskeletal and connective tissue disorders | Macitentan 10 mg | 6 | 87 |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Macitentan 10 mg | 1 | 87 |
| Total, other adverse events | Macitentan 10 mg | 57 | 87 |
| Total, serious adverse events | Macitentan 10 mg | 15 | 87 |
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 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/NCT02310672
GET https://conductscience.org/api/trials/v1/NCT02310672/events?page=2