REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension (REPAIR)
Primary Purpose
Pulmonary Arterial Hypertension
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Macitentan
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring Pulmonary Arterial Hypertension
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Need for dialysis
- Responders to acute vasoreactivity test based on medical history
- Prior use of endothelin receptor antagonists (ERAs), stimulators of soluble guanylate cyclase or prostacyclin or prostacyclin analogues
- Treatment with strong inducers of cytochrome P450 isozyme 3A4 (CYP3A4) within 4 weeks prior to study treatment initiation (e.g., carbamazepine, rifampicin, rifabutin, phenytoin and St. John's Wort)
- Treatment with strong inhibitors of CYP3A4 within 4 weeks prior to study treatment initiation (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, and saquinavir)
- Treatment with another investigational drug (planned, or taken within the 3 months prior to study treatment initiation).
- Hypersensitivity to any ERA or any excipients of the formulation of macitentan (lactose, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, polyvinyl alcohol, polysorbate, titanium dioxide, talc, xanthan gum, and lecithin soya)
- Claustrophobia
- Permanent cardiac pacemaker, automatic internal cardioverter
- Metallic implant (e.g., defibrillator, neurostimulator, hearing aid, permanent use of infusion device)
- Atrial fibrillation, multiple premature ventricular or atrial contractions, or any other condition that would interfere with proper cardiac gating during MRI.
- For patients enrolling in the metabolism sub-study only: glucose intolerance
- For patients enrolling in the biopsy sub-study only: PAH etiology belonging to Nice classification 1.4.4: PAH associated with congenital heart diseases
Sites / Locations
- Massachussetts General Hospital
- University of Minnesota
- Washington University School of Medicine
- Rudgers New Jersey Medical School
- Cornell University
- University of Pittsburgh Medical Center
- University of Texas Southwestern Medical
- St. Luke's Medical Center
- The Prince Charles Hospital
- Hopital Gabriel Montpied
- Hôpital Michallon
- "CHRU de Lille - Hôpital Albert Calmette "
- Hopital de Brabois
- Hôpital Laennec
- Hôpital Pasteur
- Hôpital Européen Georges-Pompidou
- Medizinische Klinik und Poliklinik II Universitätsklinik Bonn
- Thoraxklinik am Universitätsklinikum Heidelberg
- Universitätsklinikum Köln Herzzentrum / Klinik III für Innere Medizin
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz Centrum für Thrombose und Hämostase
- Grantham Hospital, Cardiac Medical Unit
- Queen Mary Hospital
- United Christian Hospital
- Pulmonology institute, Soroka Medical Center
- Shaare Zedek Medical Center
- Policlinico Sant'Orsola-Malpighi
- Fondazione IRCCS Policlinico San Matteo Ambulatorio Scompenso Cardiaco e Trapianti
- Hospital Pulau Pinang
- Institut Jantung Negara (National Heart Institute)
- VU University Medical Center (VUMC)
- Maastricht UMC+
- St. Antonius Ziekenhuis
- Radboud UMC
- Erasmus University medical Center
- Russian Cardiology Scientific and Production Complex
- Almazov Federal North-West Medical Research Centre of Department of Health
- National University Hospital - The Heart Institute - Cardiac Department
- National Heart Centre (NHC) Singapore
- Golden Jubilee National Hospital
- The Royal Free Hospital
- "Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital"
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Macitentan
Arm Description
All patients take open-label macitentan 10mg o.d.
Outcomes
Primary Outcome Measures
Change From Baseline in Right Ventricular Stroke Volume (RVSV) to 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.
Ratio of Week 26 to Baseline Pulmonary Vascular Resistance (PVR)
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 Outcome Measures
Change From Baseline in Right Ventricular End Diastolic Volume (RVEDV) to Week 26
Change from baseline to Week 26 in RVEDV assessed by cardiac MRI was reported.
Change From Baseline in Right Ventricular End Systolic Volume (RVESV) to Week 26
Change from baseline to Week 26 in RVESV assessed by cardiac MRI was reported.
Change From Baseline in Right Ventricular Ejection Fraction (RVEF) to Week 26 (% Blood Volume)
Change from baseline to Week 26 in RVEF based on pulmonary artery flow assessed by cardiac MRI was reported.
Change From Baseline in Right Ventricle (RV) Mass to Week 26
Change from baseline to Week 26 in RV mass assessed by cardiac MRI was reported.
Change From Baseline in Six-minutes Walk Distance (6MWD) 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.
Change From Baseline in World Health Organization Functional Class (WHO FC) 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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02310672
Brief Title
REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension
Acronym
REPAIR
Official Title
A Prospective, Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Effects of Macitentan on Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension Assessed by Cardiac Magnetic Resonance Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2015 (Actual)
Primary Completion Date
September 10, 2019 (Actual)
Study Completion Date
September 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
Pulmonary Arterial Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Macitentan
Arm Type
Experimental
Arm Description
All patients take open-label macitentan 10mg o.d.
Intervention Type
Drug
Intervention Name(s)
Macitentan
Other Intervention Name(s)
ACT-064992
Intervention Description
All patients take open-label macitentan 10mg o.d.
Primary Outcome Measure Information:
Title
Change From Baseline in Right Ventricular Stroke Volume (RVSV) to Week 26
Description
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.
Time Frame
Baseline and Week 26
Title
Ratio of Week 26 to Baseline Pulmonary Vascular Resistance (PVR)
Description
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.
Time Frame
Baseline and Week 26
Secondary Outcome Measure Information:
Title
Change From Baseline in Right Ventricular End Diastolic Volume (RVEDV) to Week 26
Description
Change from baseline to Week 26 in RVEDV assessed by cardiac MRI was reported.
Time Frame
Baseline to Week 26
Title
Change From Baseline in Right Ventricular End Systolic Volume (RVESV) to Week 26
Description
Change from baseline to Week 26 in RVESV assessed by cardiac MRI was reported.
Time Frame
Baseline to Week 26
Title
Change From Baseline in Right Ventricular Ejection Fraction (RVEF) to Week 26 (% Blood Volume)
Description
Change from baseline to Week 26 in RVEF based on pulmonary artery flow assessed by cardiac MRI was reported.
Time Frame
Baseline to Week 26
Title
Change From Baseline in Right Ventricle (RV) Mass to Week 26
Description
Change from baseline to Week 26 in RV mass assessed by cardiac MRI was reported.
Time Frame
Baseline to Week 26
Title
Change From Baseline in Six-minutes Walk Distance (6MWD) to Week 26
Description
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.
Time Frame
Baseline to Week 26
Title
Change From Baseline in World Health Organization Functional Class (WHO FC) to Week 26
Description
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).
Time Frame
Baseline to Week 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Need for dialysis
Responders to acute vasoreactivity test based on medical history
Prior use of endothelin receptor antagonists (ERAs), stimulators of soluble guanylate cyclase or prostacyclin or prostacyclin analogues
Treatment with strong inducers of cytochrome P450 isozyme 3A4 (CYP3A4) within 4 weeks prior to study treatment initiation (e.g., carbamazepine, rifampicin, rifabutin, phenytoin and St. John's Wort)
Treatment with strong inhibitors of CYP3A4 within 4 weeks prior to study treatment initiation (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, and saquinavir)
Treatment with another investigational drug (planned, or taken within the 3 months prior to study treatment initiation).
Hypersensitivity to any ERA or any excipients of the formulation of macitentan (lactose, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, polyvinyl alcohol, polysorbate, titanium dioxide, talc, xanthan gum, and lecithin soya)
Claustrophobia
Permanent cardiac pacemaker, automatic internal cardioverter
Metallic implant (e.g., defibrillator, neurostimulator, hearing aid, permanent use of infusion device)
Atrial fibrillation, multiple premature ventricular or atrial contractions, or any other condition that would interfere with proper cardiac gating during MRI.
For patients enrolling in the metabolism sub-study only: glucose intolerance
For patients enrolling in the biopsy sub-study only: PAH etiology belonging to Nice classification 1.4.4: PAH associated with congenital heart diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loïc Perchenet
Organizational Affiliation
Actelion
Official's Role
Study Director
Facility Information:
Facility Name
Massachussetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Rudgers New Jersey Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Texas Southwestern Medical
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Hopital Gabriel Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Hôpital Michallon
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
"CHRU de Lille - Hôpital Albert Calmette "
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital de Brabois
City
Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Hôpital Laennec
City
Nantes Cedex 01
ZIP/Postal Code
44093
Country
France
Facility Name
Hôpital Pasteur
City
Nice
ZIP/Postal Code
06002
Country
France
Facility Name
Hôpital Européen Georges-Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Medizinische Klinik und Poliklinik II Universitätsklinik Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Thoraxklinik am Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Universitätsklinikum Köln Herzzentrum / Klinik III für Innere Medizin
City
Köln
ZIP/Postal Code
50924
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz Centrum für Thrombose und Hämostase
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Grantham Hospital, Cardiac Medical Unit
City
Hong Kong
ZIP/Postal Code
999077
Country
Hong Kong
Facility Name
Queen Mary Hospital
City
Hong Kong
ZIP/Postal Code
999077
Country
Hong Kong
Facility Name
United Christian Hospital
City
Hong Kong
ZIP/Postal Code
999077
Country
Hong Kong
Facility Name
Pulmonology institute, Soroka Medical Center
City
Beer-Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Policlinico Sant'Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo Ambulatorio Scompenso Cardiaco e Trapianti
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Hospital Pulau Pinang
City
George Town
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Institut Jantung Negara (National Heart Institute)
City
Kuala Lumpur
ZIP/Postal Code
50400
Country
Malaysia
Facility Name
VU University Medical Center (VUMC)
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Maastricht UMC+
City
Maastricht
ZIP/Postal Code
6229
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Radboud UMC
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Erasmus University medical Center
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands
Facility Name
Russian Cardiology Scientific and Production Complex
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
Almazov Federal North-West Medical Research Centre of Department of Health
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
National University Hospital - The Heart Institute - Cardiac Department
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
National Heart Centre (NHC) Singapore
City
Singapore
ZIP/Postal Code
169609
Country
Singapore
Facility Name
Golden Jubilee National Hospital
City
Glasgow
ZIP/Postal Code
G81 4DY
Country
United Kingdom
Facility Name
The Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
"Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital"
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
34801462
Citation
Vonk Noordegraaf A, Channick R, Cottreel E, Kiely DG, Marcus JT, Martin N, Moiseeva O, Peacock A, Swift AJ, Tawakol A, Torbicki A, Rosenkranz S, Galie N. The REPAIR Study: Effects of Macitentan on RV Structure and Function in Pulmonary Arterial Hypertension. JACC Cardiovasc Imaging. 2022 Feb;15(2):240-253. doi: 10.1016/j.jcmg.2021.07.027. Epub 2021 Nov 17.
Results Reference
derived
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REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension
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