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Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome (MAESTRO)

Primary Purpose

Pulmonary Arterial Hypertension

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Macitentan 10 mg
Placebo
Sponsored by
Actelion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring exercise capacity, Eisenmenger Syndrome

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects:

    • not participating in the hemodynamic sub-study: males or females ≥ 12 years of age.
    • participating in the hemodynamic sub-study: males or females ≥ 18 years of age.
  • Subjects (including those with Down Syndrome [DS]) with confirmed Eisenmenger Syndrome [ES] (European Society of Cardiology [ESC] and the European Respiratory Society [ERS] guidelines):

    1. Established by echocardiography as:

      • Large congenital shunting defect at atrial, ventricular or arterial level*
      • and right to left shunt or bi-directional shunt with prevalent right to left direction.
    2. Resting peripheral oxygen saturation (SpO2) ≤ 90% and > 70% (pulse oximetry, room air).

The lower limit is 65% if a subject is living at an altitude greater than 2500 m above sea level.

*Subjects with any of the following open defects are eligible for the study either as an isolated defect or in combination:

  • atrial septal defect (ASD)
  • ventricular septal defect (VSD)
  • partial or complete atrioventricular septal defect (AVSD)
  • patent ductus arteriosus (PDA)
  • aortopulmonary window (AP window)
  • total or partial anomalous pulmonary venous return (TAPVR, PAPVR) The defects may be either unoperated or previously palliated surgically (provided significant residual defect remains).

The Steering Committee will review the echocardiography data of all subjects (main study and sub study) to confirm eligibility prior to Randomization.

  • Subjects with the following findings at cardiac catheterization:

    • Mean resting pulmonary arterial pressure (mPAP) > 25 mmHg
    • Pulmonary capillary wedge pressure (PCWP) or mean left atrial pressure (LAP) or left ventricular end diastolic pressure (LVED) ≤ 15 mmHg
    • Pulmonary vascular resistance (PVR) ≥ 800 dyn∙s/cm5 or ≥ 10 Wood units
  • Subjects with WHO functional class ≥ II.
  • Subjects able to reliably perform the the 6-minute walk test (6MWT) with a minimum distance of 50 m and a maximum distance of 450 m.

Exclusion Criteria:

- Main study and hemodynamic sub-study: Any of the following conditions previously known or identified via cardiac catheterization or echocardiography:

  • Pulmonary arterial or venous stenosis > 25% size of native pulmonary artery (PA) or pulmonary vein
  • Severe tricuspid regurgitation in the setting of left to right shunt at the ventricular or atrial level
  • Greater than mild tricuspid stenosis
  • Intracavitary RV outflow obstruction
  • Greater than mild mitral stenosis
  • Intracavitary LV outflow obstruction
  • Subvalvular or supravalvular aortic stenosis
  • Aortic coarctation
  • Greater than moderate mitral regurgitation
  • Recognized extracardiac systemic venous collaterals to the pulmonary venous circulation
  • Recognized hepatic wedge pressure-inferior vena cava pressure gradient >12 mm Hg
  • PCWP "v" waves >20 mmHg
  • Tetralogy of Fallot
  • Truncus arteriosus
  • Interrupted aortic arch
  • Transposition of great arteries
  • Single ventricle defects: absent AV connection (mitral or tricuspid atresia), double inlet AV connections left or right ventricle, functional univentricular heart (unbalanced AVSD, hypoplastic RV, double outlet RV), hypoplastic left heart syndrome
  • Ebstein's anomaly
  • Severe aortic regurgitation
  • Pulmonary atresia
  • PAPVR or TAPVR, ONLY if there is lung hypoplasia or if documentation confirming the absence of lung hypoplasia does not exist.

For subjects participating in the hemodynamic sub-study the following will also be considered exclusion criteria:

  • SVC stenosis >25% size of native vessel
  • PDA, AP window, TAPVR, PAPVR, or ASD sinus venosus with anomalous pulmonary veins
  • Down Syndrome

    • Subjects with deterioration of their clinical status within 3 months prior to Screening or during the Screening period.
    • Known moderate-to-severe restrictive (i.e., total lung capacity [TLC] < 60% of predicted value) or obstructive lung disease (i.e., forced expiratory volume in one second [FEV1] < 80 % of predicted value, and with FEV1 / forced vital capacity [FVC] < 70%)
    • Treatment with prostanoids within 1 month prior to Randomization
    • Subjects who initiated a PDE-5 inhibitor within 1 month prior to Randomization or those on a PDE-5 inhibitor for whom the dose has not been stable within 1 month prior to Randomization
    • Treatment with endothelin receptor antagonists (ERAs) within 1 month prior to Randomization
    • Subjects who initiated diuretics within 1 week prior to Randomization or subjects whose diuretic treatment has not been stable for at least 1 week prior to Randomization
    • Subjects being considered for an organ transplant

Sites / Locations

  • Ahmanson/UCLA Heart Disease Center
  • Stanford Hospital and Clinic
  • Emory University Hospital/the Emory Clinic
  • Barnes-Jewish Hosp/Wash Univ School of Med
  • Children'S Heart Center Nevada
  • Nationwide Children's Hospital
  • Texas Children'S Hosp - Dept of Cardiology
  • Gen Hosp Univ Vienna Dept Cardiology
  • Mhat Nat Card Hosp - Cardiology Clinic
  • Mhat Nat Card Hosp - Pediatric Clin / Ped Card Dept
  • Mhat Sveta Anna Clin Card
  • Inst Nat Torax, Unidad Cardiopatia Congenitas Del Adulto
  • Clinica Tabancura - Cardio Unit
  • Guangdong General Hospital, Cardiology Dpt
  • Wu Han Asia Heart Hosp
  • The General Hosp of Shenyang Military Region
  • Beijing Anzhen Hospital, Cardiology Dpt
  • Cardiovascular Institute&Fuwai Hospital
  • Shanghai Pulmonary Hospital, Dept of Pulmonary Circulation
  • Hosp La Timone - Dept Pediatric Cardiology
  • Hosp Laennec - Dept Cardiology
  • Hosp Pompidou - Dept Congenital Cardiac Diseases
  • Hosp Cardiology Haut Leveque - Dept Congenital Diseases
  • Herzzentrum Berlin, Ped Cardiology
  • Universitätsklinikum Giessen - Pediatric Heart Center
  • Uni Heidelberg - Kinderkardiologie
  • Ahepa University General Hospital
  • Rabin Medical Centre - Pulmonology
  • Institut Jantung Negara
  • Unidad de Investigacion Clin En Med, Sc (Udicem)
  • Instituto Nacional de Cardiologia (Inc) Ignacio Chavez
  • Instituto de Corazon de Querètaro
  • PHC, MAB
  • Cardiology Gdańsk Univ
  • Cardiology Kraków Univ
  • Cardiology Wrocław
  • Hosp Univ Coimbra - Dpt Cardiology
  • Hosp Sta Marta - Dept Cardiology
  • Er Inst For Cardvasc Dis "Prof Dr Cc Iliescu" - Card Ii
  • Cardio Med Srl
  • Clin Hosp For Inf and Pulm Dis Victor Babes - Ii Pulm
  • Sci Institute Systemic Problems Cardio Diseases Kemerovo
  • Russian Cardiology Scientific and Production Complex
  • V. A. Almazov Institute of Cardiology
  • Dedinje Cardiovasc Inst - Cardiovasc Research Ctr
  • Mother and Child Health Care Inst "Dr Vukan Cupic"
  • Clin Hosp Ctr Zemun - Cardiology Dept
  • Hosp Univ Vall D'Hebron - Dpt Congenital Heart Disease Adult
  • Hosp Univ Virgen Macarena - Dpt Cardiology
  • Hosp Universitario La Fe Dpt Cardiology
  • Omu Pediatry
  • Bristol Univ Hosp Congenital Heart Centre
  • Hanoi Medical University Hospital
  • Children's Hospital, Ho Chi Minh
  • Tam Duc Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Macitentan

Placebo

Arm Description

Subjects receive macitentan 10 mg oral tablet once daily

Subjects receive macitentan-matching placebo oral tablet once daily

Outcomes

Primary Outcome Measures

Change From Baseline to Week 16 in Exercise Capacity, as Measured by 6-minute Walk Distance (6MWD)
The purpose of the six minute walk is to test exercise tolerance and capacity. The test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.

Secondary Outcome Measures

Change From Baseline to Week 16 in WHO Functional Class
A shift in WHO functional classes is considered an 'improvement' when shifting to a lower class (e.g. from class III to class II) or a 'worsening' when shifting to a higher class (e.g. from class III to class IV). Definition of functional classes as follows - Class I: no symptoms with exercise or at rest. Class II: No symptoms at rest but uncomfortable and short of breath with normal activity such as climbing a flight of stairs, grocery shopping, or making the bed. Class III: May not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting (e.g. doing normal chores around the house, have to take breaks while doing activities of daily living). Class IV: Symptoms at rest and severe symptoms with any activity. Most patients also have edema in the feet and ankles as result of right heart failure.
Change From Baseline to Week 16 in Dyspnea, Assessed by the Borg Dyspnea Index
This outcome measures the difference in the Borg dyspnea index collected at the end of the 6-minute walk test (6MWT) at Week 16 compared to baseline. The Borg dyspnea index rates the severity of dyspnea (difficult or labored breathing) on a scale from 0 ('Nothing at all') to 10 ('Very, very severe - maximal'). A decrease in the Borg dyspnea index indicates an improvement.
Change From Baseline to Week 16 in Quality of Life (QoL), Assessed by the Short Form-36 (SF-36) Questionnaire
The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of the functional health and well-being scores (i.e., physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health), as well as psychometrically based physical and mental health summary measures and a preference-based health utility (health rated as much better now than one year ago to much worse now than one year ago). It is a generic measure, as opposed to one that targets a specific age, disease, or treatment group. For each of the domains and scores that the SF36 measures an aggregate percentage score is produced. The percentage scores range from 0% (lowest or worst possible level of functioning) to 100% (highest or best possible level of functioning). A higher score for the individual domains and summary component scores indicates a better condition of the subject.

Full Information

First Posted
November 29, 2012
Last Updated
February 22, 2018
Sponsor
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT01743001
Brief Title
Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome
Acronym
MAESTRO
Official Title
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase 3 Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 21, 2013 (Actual)
Primary Completion Date
December 1, 2016 (Actual)
Study Completion Date
December 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Clinical study to assess the efficacy, safety, and tolerability of macitentan in subjects with Eisenmenger Syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
exercise capacity, Eisenmenger Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
226 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Macitentan
Arm Type
Experimental
Arm Description
Subjects receive macitentan 10 mg oral tablet once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects receive macitentan-matching placebo oral tablet once daily
Intervention Type
Drug
Intervention Name(s)
Macitentan 10 mg
Other Intervention Name(s)
ACT-064992
Intervention Description
Macitentan 10 mg oral tablet once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Macitentan-matching placebo oral tablet once daily
Primary Outcome Measure Information:
Title
Change From Baseline to Week 16 in Exercise Capacity, as Measured by 6-minute Walk Distance (6MWD)
Description
The purpose of the six minute walk is to test exercise tolerance and capacity. The test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
Time Frame
From baseline to Week 16
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 16 in WHO Functional Class
Description
A shift in WHO functional classes is considered an 'improvement' when shifting to a lower class (e.g. from class III to class II) or a 'worsening' when shifting to a higher class (e.g. from class III to class IV). Definition of functional classes as follows - Class I: no symptoms with exercise or at rest. Class II: No symptoms at rest but uncomfortable and short of breath with normal activity such as climbing a flight of stairs, grocery shopping, or making the bed. Class III: May not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting (e.g. doing normal chores around the house, have to take breaks while doing activities of daily living). Class IV: Symptoms at rest and severe symptoms with any activity. Most patients also have edema in the feet and ankles as result of right heart failure.
Time Frame
From baseline to Week 16
Title
Change From Baseline to Week 16 in Dyspnea, Assessed by the Borg Dyspnea Index
Description
This outcome measures the difference in the Borg dyspnea index collected at the end of the 6-minute walk test (6MWT) at Week 16 compared to baseline. The Borg dyspnea index rates the severity of dyspnea (difficult or labored breathing) on a scale from 0 ('Nothing at all') to 10 ('Very, very severe - maximal'). A decrease in the Borg dyspnea index indicates an improvement.
Time Frame
From baseline to Week 16
Title
Change From Baseline to Week 16 in Quality of Life (QoL), Assessed by the Short Form-36 (SF-36) Questionnaire
Description
The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of the functional health and well-being scores (i.e., physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health), as well as psychometrically based physical and mental health summary measures and a preference-based health utility (health rated as much better now than one year ago to much worse now than one year ago). It is a generic measure, as opposed to one that targets a specific age, disease, or treatment group. For each of the domains and scores that the SF36 measures an aggregate percentage score is produced. The percentage scores range from 0% (lowest or worst possible level of functioning) to 100% (highest or best possible level of functioning). A higher score for the individual domains and summary component scores indicates a better condition of the subject.
Time Frame
From baseline to Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects: not participating in the hemodynamic sub-study: males or females ≥ 12 years of age. participating in the hemodynamic sub-study: males or females ≥ 18 years of age. Subjects (including those with Down Syndrome [DS]) with confirmed Eisenmenger Syndrome [ES] (European Society of Cardiology [ESC] and the European Respiratory Society [ERS] guidelines): Established by echocardiography as: Large congenital shunting defect at atrial, ventricular or arterial level* and right to left shunt or bi-directional shunt with prevalent right to left direction. Resting peripheral oxygen saturation (SpO2) ≤ 90% and > 70% (pulse oximetry, room air). The lower limit is 65% if a subject is living at an altitude greater than 2500 m above sea level. *Subjects with any of the following open defects are eligible for the study either as an isolated defect or in combination: atrial septal defect (ASD) ventricular septal defect (VSD) partial or complete atrioventricular septal defect (AVSD) patent ductus arteriosus (PDA) aortopulmonary window (AP window) total or partial anomalous pulmonary venous return (TAPVR, PAPVR) The defects may be either unoperated or previously palliated surgically (provided significant residual defect remains). The Steering Committee will review the echocardiography data of all subjects (main study and sub study) to confirm eligibility prior to Randomization. Subjects with the following findings at cardiac catheterization: Mean resting pulmonary arterial pressure (mPAP) > 25 mmHg Pulmonary capillary wedge pressure (PCWP) or mean left atrial pressure (LAP) or left ventricular end diastolic pressure (LVED) ≤ 15 mmHg Pulmonary vascular resistance (PVR) ≥ 800 dyn∙s/cm5 or ≥ 10 Wood units Subjects with WHO functional class ≥ II. Subjects able to reliably perform the the 6-minute walk test (6MWT) with a minimum distance of 50 m and a maximum distance of 450 m. Exclusion Criteria: - Main study and hemodynamic sub-study: Any of the following conditions previously known or identified via cardiac catheterization or echocardiography: Pulmonary arterial or venous stenosis > 25% size of native pulmonary artery (PA) or pulmonary vein Severe tricuspid regurgitation in the setting of left to right shunt at the ventricular or atrial level Greater than mild tricuspid stenosis Intracavitary RV outflow obstruction Greater than mild mitral stenosis Intracavitary LV outflow obstruction Subvalvular or supravalvular aortic stenosis Aortic coarctation Greater than moderate mitral regurgitation Recognized extracardiac systemic venous collaterals to the pulmonary venous circulation Recognized hepatic wedge pressure-inferior vena cava pressure gradient >12 mm Hg PCWP "v" waves >20 mmHg Tetralogy of Fallot Truncus arteriosus Interrupted aortic arch Transposition of great arteries Single ventricle defects: absent AV connection (mitral or tricuspid atresia), double inlet AV connections left or right ventricle, functional univentricular heart (unbalanced AVSD, hypoplastic RV, double outlet RV), hypoplastic left heart syndrome Ebstein's anomaly Severe aortic regurgitation Pulmonary atresia PAPVR or TAPVR, ONLY if there is lung hypoplasia or if documentation confirming the absence of lung hypoplasia does not exist. For subjects participating in the hemodynamic sub-study the following will also be considered exclusion criteria: SVC stenosis >25% size of native vessel PDA, AP window, TAPVR, PAPVR, or ASD sinus venosus with anomalous pulmonary veins Down Syndrome Subjects with deterioration of their clinical status within 3 months prior to Screening or during the Screening period. Known moderate-to-severe restrictive (i.e., total lung capacity [TLC] < 60% of predicted value) or obstructive lung disease (i.e., forced expiratory volume in one second [FEV1] < 80 % of predicted value, and with FEV1 / forced vital capacity [FVC] < 70%) Treatment with prostanoids within 1 month prior to Randomization Subjects who initiated a PDE-5 inhibitor within 1 month prior to Randomization or those on a PDE-5 inhibitor for whom the dose has not been stable within 1 month prior to Randomization Treatment with endothelin receptor antagonists (ERAs) within 1 month prior to Randomization Subjects who initiated diuretics within 1 week prior to Randomization or subjects whose diuretic treatment has not been stable for at least 1 week prior to Randomization Subjects being considered for an organ transplant
Facility Information:
Facility Name
Ahmanson/UCLA Heart Disease Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford Hospital and Clinic
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Emory University Hospital/the Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Barnes-Jewish Hosp/Wash Univ School of Med
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Children'S Heart Center Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Texas Children'S Hosp - Dept of Cardiology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2303
Country
United States
Facility Name
Gen Hosp Univ Vienna Dept Cardiology
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Mhat Nat Card Hosp - Cardiology Clinic
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
Mhat Nat Card Hosp - Pediatric Clin / Ped Card Dept
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
Mhat Sveta Anna Clin Card
City
Sofia
ZIP/Postal Code
1750
Country
Bulgaria
Facility Name
Inst Nat Torax, Unidad Cardiopatia Congenitas Del Adulto
City
Providencia
Country
Chile
Facility Name
Clinica Tabancura - Cardio Unit
City
Santiago
ZIP/Postal Code
7650018
Country
Chile
Facility Name
Guangdong General Hospital, Cardiology Dpt
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Wu Han Asia Heart Hosp
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
The General Hosp of Shenyang Military Region
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
Facility Name
Beijing Anzhen Hospital, Cardiology Dpt
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Cardiovascular Institute&Fuwai Hospital
City
Beijing
ZIP/Postal Code
100037
Country
China
Facility Name
Shanghai Pulmonary Hospital, Dept of Pulmonary Circulation
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Hosp La Timone - Dept Pediatric Cardiology
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Hosp Laennec - Dept Cardiology
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Hosp Pompidou - Dept Congenital Cardiac Diseases
City
Paris Cedex 15
ZIP/Postal Code
75908
Country
France
Facility Name
Hosp Cardiology Haut Leveque - Dept Congenital Diseases
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Herzzentrum Berlin, Ped Cardiology
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitätsklinikum Giessen - Pediatric Heart Center
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Uni Heidelberg - Kinderkardiologie
City
Heidelberg
ZIP/Postal Code
D-69120
Country
Germany
Facility Name
Ahepa University General Hospital
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Facility Name
Rabin Medical Centre - Pulmonology
City
Petach Tikvah
ZIP/Postal Code
49100
Country
Israel
Facility Name
Institut Jantung Negara
City
Kuala Lumpur
ZIP/Postal Code
50400
Country
Malaysia
Facility Name
Unidad de Investigacion Clin En Med, Sc (Udicem)
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64718
Country
Mexico
Facility Name
Instituto Nacional de Cardiologia (Inc) Ignacio Chavez
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Instituto de Corazon de Querètaro
City
Querétaro
Country
Mexico
Facility Name
PHC, MAB
City
Manila
Country
Philippines
Facility Name
Cardiology Gdańsk Univ
City
Gdańsk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Cardiology Kraków Univ
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Cardiology Wrocław
City
Wrocław
ZIP/Postal Code
51-124
Country
Poland
Facility Name
Hosp Univ Coimbra - Dpt Cardiology
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Hosp Sta Marta - Dept Cardiology
City
Lisboa
ZIP/Postal Code
1169-024
Country
Portugal
Facility Name
Er Inst For Cardvasc Dis "Prof Dr Cc Iliescu" - Card Ii
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
Cardio Med Srl
City
Targu-Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Clin Hosp For Inf and Pulm Dis Victor Babes - Ii Pulm
City
Timisoara
ZIP/Postal Code
300312
Country
Romania
Facility Name
Sci Institute Systemic Problems Cardio Diseases Kemerovo
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Russian Cardiology Scientific and Production Complex
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
V. A. Almazov Institute of Cardiology
City
St Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Dedinje Cardiovasc Inst - Cardiovasc Research Ctr
City
Belgrade
ZIP/Postal Code
11040
Country
Serbia
Facility Name
Mother and Child Health Care Inst "Dr Vukan Cupic"
City
Belgrade
ZIP/Postal Code
11070
Country
Serbia
Facility Name
Clin Hosp Ctr Zemun - Cardiology Dept
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Hosp Univ Vall D'Hebron - Dpt Congenital Heart Disease Adult
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hosp Univ Virgen Macarena - Dpt Cardiology
City
Sevilla
ZIP/Postal Code
41007
Country
Spain
Facility Name
Hosp Universitario La Fe Dpt Cardiology
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Omu Pediatry
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Facility Name
Bristol Univ Hosp Congenital Heart Centre
City
Bristol
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom
Facility Name
Hanoi Medical University Hospital
City
Hanoi
Country
Vietnam
Facility Name
Children's Hospital, Ho Chi Minh
City
Ho Chi Minh
Country
Vietnam
Facility Name
Tam Duc Hospital
City
Ho Chi Minh
Country
Vietnam

12. IPD Sharing Statement

Citations:
PubMed Identifier
30586694
Citation
Gatzoulis MA, Landzberg M, Beghetti M, Berger RM, Efficace M, Gesang S, He J, Papadakis K, Pulido T, Galie N; MAESTRO Study Investigators. Evaluation of Macitentan in Patients With Eisenmenger Syndrome. Circulation. 2019 Jan 2;139(1):51-63. doi: 10.1161/CIRCULATIONAHA.118.033575.
Results Reference
derived

Learn more about this trial

Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome

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