Trial · NCT02554903
Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation
NCT02554903, Phase 2, Completed, Actelion; results first posted 2021-04-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation. Trials, record NCT02554903. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02554903
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation
- NCT number
- NCT02554903
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 57 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Pulmonary Hypertension
- Interventions
- Macitentan 10mg, Placebo sugar pill
- First posted
- 2015-09-18
- Last updated
- 2025-03-30
- Results first posted
- 2021-04-01
- Limitations and caveats
- A limitation of this study was its slow enrollment and a final sample size that was less than the predefined target.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pulmonary Vascular Resistance (PVR) Ratio of Week 12 to Baseline | Baseline to Week 12 | PVR ratio equals to Week 12 PVR / Baseline PVR. PVR represents the resistance against which the right ventricle needs to pump. PVR was calculated using the following formula: mean pulmonary arterial pressure (mPAP) - pulmonary artery wedge pressure (PAWP)/cardiac output (CO); where mPAP and PAWP were measured at end-expiration and CO was measured in triplicate using the thermodilution method. |
| Secondary | Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP) | Baseline to Week 12 | mRAP was collected in the eCRF (electronic case record form). Right atrial pressure (RAP) is the blood pressure in the right atrium of the heart. Change from baseline to Week 12 in mRAP was measured at rest and no correction for multiple testing was applied. |
| Secondary | Change From Baseline to Week 12 in Mean Pulmonary Arterial Pressure (mPAP) | Baseline to Week 12 | mPAP was collected in the eCRF. The pulmonary artery pressure is a measure of the blood pressure found in the main pulmonary artery. Change from baseline to Week 12 in mPAP was measured at rest and no correction for multiple testing was applied. |
| Secondary | Change From Baseline to Week 12 in Pulmonary Arterial Wedge Pressure (PAWP) | Baseline to Week 12 | PAWP was collected in the eCRF. PAWP is pressure within the pulmonary arterial system when the catheter tip is 'wedged' in the tapering branch of one of the pulmonary arteries. Change from baseline to Week 12 in PAWP was measured at rest and no correction for multiple testing was applied. |
| Secondary | Change From Baseline to Week 12 in Cardiac Index (CI) | Baseline to Week 12 | CI was calculated as Cardiac Output (CO)/body surface area (BSA), where CO is Thermodilution Cardiac Output (Liters per minute \[L/min\]) and BSA (m\^2) equals to 0.007184\*weight\^0.425 (kilograms)\*height\^0.725 (centimeter). CI was represented in liters per minute per square meter (L/min/m\^2). Change from baseline to Week 12 in CI was measured at rest and no correction for multiple testing was applied. |
| Secondary | Change From Baseline to Week 12 in Total Pulmonary Resistance (TPR) | Baseline to Week 12 | TPR was calculated as mPAP/CO where mPAP is mean pulmonary arterial pressure and CO is cardiac output. Change from baseline to Week 12 in TPR was calculated at rest and no correction for multiple testing was applied. |
| Secondary | Change From Baseline to Week 12 in Mixed Venous Oxygen Saturation (SvO2) | Baseline to Week 12 | Mixed venous oxygen saturation measures the end result of oxygen consumption and delivery. Change from baseline to Week 12 in SvO2 was reported and measured at rest and no correction for multiple testing was applied. |
| Secondary | Change From Baseline to Week 12 in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Levels | Baseline to Week 12 | NT-proBNP levels in the blood are used for diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure. |
| Secondary | Change From Baseline to Week 12 in Participants World Health Organization (WHO) Functional Class (FC) | Baseline to Week 12 | 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). Change from baseline in WHO FC was reported. WHO FC was categorized as worsening (change greater than \[\>\] 0); improvement (change less than \[\<\] 0); or no change (change equals to \[=\] 0). |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pulmonary Vascular Resistance (PVR) Ratio of Week 12 to Baseline | Baseline to Week 12 | The Full Analysis Set (FAS) included all participants randomized. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure. Imputation for missing PAWP value was done using mPAP and CO or with left ventricular end diastolic pressure (LVEDP) values of same visit (if available). | Ratio | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP) | Baseline to Week 12 | The FAS included all participants randomized. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure. | millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Mean Pulmonary Arterial Pressure (mPAP) | Baseline to Week 12 | The FAS included all participants randomized. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure. | mmHg | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Pulmonary Arterial Wedge Pressure (PAWP) | Baseline to Week 12 | The FAS included all participants randomized. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure. | mmHg | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Cardiac Index (CI) | Baseline to Week 12 | The FAS included all participants randomized. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure. | L/min/m^2 | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Total Pulmonary Resistance (TPR) | Baseline to Week 12 | The FAS included all participants randomized. Here 'N' (number of participants analyzed) includes all participants who were evaluable for this outcome measure. | Wood Unit | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Mixed Venous Oxygen Saturation (SvO2) | Baseline to Week 12 | The FAS included all participants randomized. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure. | Percentage of SvO2 | MEAN |
| SECONDARY | Change From Baseline to Week 12 in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Levels | Baseline to Week 12 | The FAS included all participants randomized. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure. | nanograms/Liter (ng/L) | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Participants World Health Organization (WHO) Functional Class (FC) | Baseline to Week 12 | The FAS included all participants randomized. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pulmonary Vascular Resistance (PVR) Ratio of Week 12 to Baseline | Macitentan 10 Milligrams (mg) | 0.585 | Standard Deviation 0.2280 | Ratio | |
| Pulmonary Vascular Resistance (PVR) Ratio of Week 12 to Baseline | Placebo | 0.757 | Standard Deviation 0.2578 | Ratio | |
| Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP) | Macitentan 10 Milligrams (mg) | 0.8 | Standard Deviation 5.49 | millimeters of mercury (mmHg) | |
| Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP) | Placebo | -1.4 | Standard Deviation 4.71 | millimeters of mercury (mmHg) | |
| Change From Baseline to Week 12 in Mean Pulmonary Arterial Pressure (mPAP) | Macitentan 10 Milligrams (mg) | -3.84 | Standard Deviation 8.821 | mmHg | |
| Change From Baseline to Week 12 in Mean Pulmonary Arterial Pressure (mPAP) | Placebo | -3.86 | Standard Deviation 7.982 | mmHg | |
| Change From Baseline to Week 12 in Pulmonary Arterial Wedge Pressure (PAWP) | Macitentan 10 Milligrams (mg) | 4.0 | Standard Deviation 7.86 | mmHg | |
| Change From Baseline to Week 12 in Pulmonary Arterial Wedge Pressure (PAWP) | Placebo | 1.0 | Standard Deviation 4.93 | mmHg | |
| Change From Baseline to Week 12 in Cardiac Index (CI) | Macitentan 10 Milligrams (mg) | 0.093 | Standard Deviation 0.4680 | L/min/m^2 | |
| Change From Baseline to Week 12 in Cardiac Index (CI) | Placebo | 0.041 | Standard Deviation 0.4576 | L/min/m^2 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Macitentan 10 Milligrams (mg) | 28 | |
| Overall Study | STARTED | Placebo | 29 | |
| Overall Study | COMPLETED | Macitentan 10 Milligrams (mg) | 24 | |
| Overall Study | COMPLETED | Placebo | 24 | |
| Overall Study | NOT COMPLETED | Macitentan 10 Milligrams (mg) | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 5 |
Source ClinicalTrials.gov
Adverse events392
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 | Anaemia | Blood and lymphatic system disorders | Macitentan 10 Milligrams (mg) | 1 | 28 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 29 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Macitentan 10 Milligrams (mg) | 1 | 28 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Placebo | 0 | 29 | |
| other | Atrial Flutter | Cardiac disorders | Macitentan 10 Milligrams (mg) | 1 | 28 | |
| other | Atrial Flutter | Cardiac disorders | Placebo | 1 | 29 | |
| other | Cardiogenic Shock | Cardiac disorders | Macitentan 10 Milligrams (mg) | 1 | 28 | |
| other | Cardiogenic Shock | Cardiac disorders | Placebo | 0 | 29 | |
| other | Cardiorenal Syndrome | Cardiac disorders | Macitentan 10 Milligrams (mg) | 1 | 28 | |
| other | Cardiorenal Syndrome | Cardiac disorders | Placebo | 0 | 29 |
1 to 10 of 392Source ClinicalTrials.gov
See all 392 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Macitentan 10 Milligrams (mg) | 1 | 28 |
| Total, all-cause mortality | Placebo | 2 | 29 |
| Total, other adverse events | Macitentan 10 Milligrams (mg) | 24 | 28 |
| Total, other adverse events | Placebo | 24 | 29 |
| Total, serious adverse events | Macitentan 10 Milligrams (mg) | 16 | 28 |
| Total, serious adverse events | Placebo | 16 | 29 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39635465 | DERIVED |
Source PubMed
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 |
|---|---|
| Macitentan 10 Milligrams (mg) vs Placebo: deaths from any cause | Trial comparisons |
| Macitentan 10 Milligrams (mg) 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/NCT02554903
GET https://conductscience.org/api/trials/v1/NCT02554903/results?page=2