REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension

Completed · Phase 4

Conditions studied: Pulmonary Arterial Hypertension

In brief

The study evaluates the effect of macitentan on right ventricular and hemodynamic properties in patients with symptomatic pulmonary arterial hypertension. Patients are treated with macitentan for 1 year. Patients undergo right heart catheterization (RHC) at baseline and Week 26. They also undergo cardiac magnetic resonance imaging (MRI) at baseline, Week 26 and Week 52. Safety is monitored throughout the study. The study has three stub-studies. Each patient can participate in no sub-study or in one sub-study. The sub-studies are: (1) metabolism sub-study (with PET-MR scans); (2) biopsy sub-study (biopsies taken during the RHC); (3) Echo sub-study.

Key facts

Study ID

NCT02310672

Run by

Actelion

People needed

89

Starts

2015-06-01

Expected to finish

2019-09-10

Last updated by the study team

2025-03-30

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent prior to any study-mandated procedure
• Symptomatic pulmonary arterial hypertension (PAH)
• World Health Organization (WHO) Functional Class (FC) I to III
• PAH etiology belonging to one of the following groups according to Nice classification:
• Idiopathic PAH
• Heritable PAH
• Drug- and toxin-induced PAH
• PAH associated with congenital heart diseases: only simple (atrial septal defect, ventricular septal defect, patent ductus arteriosus) congenital systemic to pulmonary shunts at least 2 year post surgical repair
• Hemodynamic diagnosis of PAH confirmed by right heart catheterization (RHC) during screening showing:
• mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg and
• PCWP (pulmonary capillary wedge pressure) or left ventricular end diastolic pressure (LVEDP) ≤ 12 mmHg and pulmonary vascular resistance (PVR) ≥ 4 Wood Units (WU) (320 dyn.sec.cm-5) or
• 12 mmHg ≤ PCWP or LVEDP ≤ 15 mmHg and PVR ≥ 6WU (480 dyn.sec.cm-5)
• 6-minute walk distance (6MWD) ≥ 150 m during screening
• For patients treated with oral diuretics, treatment dose must have been stable at least 1 month prior to RHC during the screening period
• For patients treated with phosphodiesterase type-5 (PDE-5) inhibitors, treatment dose must have been stable at least 3 months prior to RHC during the screening period
• For patients treated with beta blockers, treatment dose must have been stable at least 1 month prior to the RHC during the screening period
• Men or women ≥18 and < 65 years
• Women of childbearing potential (defined in protocol) must:
• Have a negative serum pregnancy test during screening and a negative urine pregnancy test on Day 1, and
• Agree to use reliable methods of contraception (defined in protocol) from screening up to 30 days after study treatment discontinuation, and
• Agree to perform monthly pregnancy tests up to 30 days after study treatment discontinuation

You may not qualify if…

• Body weight < 40 kg
• Body mass index (BMI) > 35kg/m2. For patients with 30kg/m2 < BMI < 35kg/m2, an eligibility form will be submitted to a Steering Committee member who will reserve the right to exclude the patient.
• Pregnancy, breastfeeding or intention to become pregnant during the study
• Recently started (< 8 weeks prior to informed consent signature) or planned cardio-pulmonary rehabilitation program
• Known concomitant life-threatening disease with a life expectancy < 12 months
• Any condition likely to affect protocol or treatment compliance
• Hospitalization for PAH within 3 months prior to informed consent signature
• Left atrial volume indexed for body surface area ≥ 43mL/m2 by echocardiography or cardiac MRI
• Valvular disease grade 2 or higher
• History of pulmonary embolism or deep vein thrombosis
• Documented moderate to severe chronic obstructive pulmonary disease
• Documented moderate to severe restrictive lung disease
• Historical evidence of significant coronary artery disease established by:
• History of myocardial infarction or
• More than 50% stenosis in a coronary artery (by percutaneous coronary intervention or angiography) or
• Elevation of the ST segment on electrocardiogram or
• History of coronary artery bypass grafting or
• Stable angina
• Diabetes mellitus
• Moderate to severe renal insufficiency (calculated creatinine clearance < 60 mL/min/1.73 m2)
• Cancer
• Systolic blood pressure < 90 mmHg
• Severe hepatic impairment (with or without cirrhosis) according to National Cancer Institute organ dysfunction working group criteria, defined as total bilirubin > 3 × upper limit of the normal range (ULN) accompanied by an aspartate aminotransferase (AST) elevation > ULN at Screening.
• Hemoglobin < 100g/L
• AST and/or alanine aminotransferase (ALT) > 3× ULN

Where it is running

• Massachussetts General Hospital — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Rudgers New Jersey Medical School — New Brunswick, New Jersey, United States
• Cornell University — New York, New York, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• University of Texas Southwestern Medical — Dallas, Texas, United States
• St. Luke's Medical Center — Milwaukee, Wisconsin, United States
• The Prince Charles Hospital — Chermside, Queensland, Australia
• Hopital Gabriel Montpied — Clermont-Ferrand, France
• Hôpital Michallon — La Tronche, France
• "CHRU de Lille - Hôpital Albert Calmette " — Lille, France
• Hopital de Brabois — Nancy, France
• Hôpital Laennec — Nantes, France
• Hôpital Pasteur — Nice, France
• Hôpital Européen Georges-Pompidou — Paris, France
• Medizinische Klinik und Poliklinik II Universitätsklinik Bonn — Bonn, Germany
• Universitätsklinikum Köln Herzzentrum / Klinik III für Innere Medizin — Cologne, Germany
• Thoraxklinik am Universitätsklinikum Heidelberg — Heidelberg, Germany
• Universitätsmedizin der Johannes Gutenberg-Universität Mainz Centrum für Thrombose und Hämostase — Mainz, Germany
• Grantham Hospital, Cardiac Medical Unit — Hong Kong, Hong Kong
• Queen Mary Hospital — Hong Kong, Hong Kong
• United Christian Hospital — Hong Kong, Hong Kong
• Pulmonology institute, Soroka Medical Center — Beersheba, Israel
• Shaare Zedek Medical Center — Jerusalem, Israel

Full record on ClinicalTrials.gov

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