Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation
Public ClinicalTrials.gov record NCT02554903. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
STUDY OBJECTIVES Primary objective To evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) as compared to placebo in subjects with pulmonary hypertension (PH) after left ventricular assist device (LVAD) implantation. Secondary objectives To evaluate the effect of macitentan 10 mg as compared to placebo on cardio-pulmonary hemodynamics and disease severity in subjects with PH after LVAD implantation. To evaluate the safety and tolerability of macitentan 10 mg in subjects with PH after LVAD implantation. Exploratory objectives To explore the potential effect of macitentan 10 mg as compared to placebo on right ventricular function in subjects with PH after LVAD implantation. To explore the potential effect of macitentan 10 mg as compared to placebo on selected clinical events in subjects with PH after LVAD implantation. To explore the potential effect of macitentan 10 mg as compared to placebo on renal function as measured by glomerular filtration rate (GFR) in subjects with PH after LVAD implantation.
Study identification
- NCT ID
- NCT02554903
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 57 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 27, 2016
- Primary completion
- Mar 12, 2020
- Completion
- Mar 12, 2020
- Last update posted
- Mar 29, 2025
2016 – 2020
United States locations
- U.S. sites
- 50
- U.S. states
- 25
- U.S. cities
- 45
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| #125_Mayo Clinic Arizona | Phoenix | Arizona | 85054 | — |
| #144_University of Arizona | Tucson | Arizona | 85724 | — |
| #106_Cedars-Sinai Medical Center | Beverly Hills | California | 90211 | — |
| #154_University of California San Diego | La Jolla | California | 92037 | — |
| #110_Sutter Heart Institute | Sacramento | California | 95819 | — |
| #132_University of California San Francisco | San Francisco | California | 94143 | — |
| #123_MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| #126_Florida Hospital | Orlando | Florida | 32804 | — |
| #135_University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| #113_Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | — |
| #108_Indiana University Health Physicians Cardiology | Indianapolis | Indiana | 46202 | — |
| #112_St. Vincent Medical Group, Inc | Indianapolis | Indiana | 46260 | — |
| #120_University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| #117_University of Louisville | Louisville | Kentucky | 40202 | — |
| #105_Ochsner Medical Center | New Orleans | Louisiana | 70121 | — |
| #129_John Hopkins University Medical Center | Baltimore | Maryland | 21287 | — |
| #143_Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| #138_Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| #119_Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| #115_Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| #102_Mayo Clinic | Rochester | Minnesota | 55905 | — |
| #150_Saint Luke's Hospital | Kansas City | Missouri | 64111 | — |
| #104_Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| #131_University of Nebraska Medical Center | Omaha | Nebraska | 68918 | — |
| #103_Weill Cornell Medical College | New York | New York | 10021 | — |
| #139_Icahn School of Medicine at Mount Sinai | New York | New York | 94080 | — |
| #133_Montefiore Medical Center | The Bronx | New York | 10467 | — |
| #147_Westchester Medical Center | Valhalla | New York | 10595 | — |
| #148_University of Cincinnati Medical Center | Cincinnati | Ohio | 45242 | — |
| #153_Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| #101_The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | — |
| #145_The University of Toledo Medical Center | Toledo | Ohio | 43614 | — |
| #121_Integris Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | — |
| #142_Penn State Heart and Vascular Institute | Hershey | Pennsylvania | 17033 | — |
| #140_Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| #134_Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| #130_University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| #141_Palmetto Health / Palmetto Heart | Columbia | South Carolina | 29203 | — |
| #151_Stern Cardiovascular Foundation | Memphis | Tennessee | 38120 | — |
| #146_Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| #149_Seton Heart Institute | Austin | Texas | 78705 | — |
| #136_Baylor Health - Baylor University Medical Center | Dallas | Texas | 75226 | — |
| #107_Houston Methodist Hospital | Houston | Texas | 77030 | — |
| #122_Advanced Heart Failure Clinic - HCM | San Antonio | Texas | 78229 | — |
| #127_The University of Utah | Salt Lake City | Utah | 84112 | — |
| #114_University of Virginia | Charlottesville | Virginia | 22905 | — |
| #111_Inova Fairfax Hospital | Falls Church | Virginia | 22042 | — |
| #116_Virginia Commonwealth University (VCU) Medical Center | Richmond | Virginia | 23298 | — |
| #155_University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02554903, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 29, 2025 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02554903 live on ClinicalTrials.gov.