Back to results(RIGHT HEART III Study - Right Ventricular Hemodynamic Evaluation and Response to Treatment) (RightHeartIII)
Primary Purpose
Pulmonary Arterial Hypertension (PAH)
Status
Recruiting
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Riciguat Group
Macitentan Group
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension (PAH)
Eligibility Criteria
Inclusion Criteria:
- Female and male patients, 18 years ≤ age ≤ 85 years
- Diagnosis of Pulmonary Hypertension Group 1 according to Nizza Definition (PAH) confirmed by invasive methods, WHO functional class II and III
- Existing clinical need to repeat a right ventricular catheter examination (as recommended by the current "Kölner Konsensuskonferenz")
- Ability to understand study goals and agree to study participation
Hemodynamic criteria of ventricular catheter examination:
- Pulmonary vascular resistance (PVR)> 240 dyn x sec x cm-5
- Mean Pulmonary Arterial Pressure (mPAP) ≥ 25 mmHg
- Clinical need to receive treatment with a drug approved for the treatment of PAH for the first time
- Potentially fertile women must agree to use highly effective methods of contraception, either through abstinence or the use of at least two methods of contraception from the date of consent until one month after the end of the study. An effective pregnancy protection consists in the combination of a hormonal contraceptive (oral, injectable or implant) and a barrier method (condom or diaphragm with a vaginal spermicide)
- Written consent to the clinical trial
Exclusion Criteria:
Existing therapy with positive inotropic drugs such as Catecholamines (including norepinephrine, dobutamine, suprarenin)
- Pregnancy or breastfeeding
- General contraindication for examinations to be performed during the study
- Hypersensitivity to the active substances or to a constituent of the study medication (in particular lactose and soya)
- Simultaneous participation in another medical therapy study
- Simultaneous participation in another non-drug study that would preclude participation in this study
- Participation within one month after completing another therapy study
- Heavy liver function disorders
- Existing increase in liver aminotransferases (aspartate aminotransferase (AST) and / or alanine aminotransferase (ALT))> 3 × ULN
- Systolic blood pressure <95 mmHg
- Pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP)
- anemia (Hb <10 g / dl)
- Concomitant medication with potential interaction to macitentan and/or riociguat according to the IB
- Severe kidney dysfunction
- Severe hemoptysis
- History of bronchial artery embolization
- smoker
Sites / Locations
- Klinik III für Innere Medizin Herzzentrum der Universität zu Köln
- Abteilung Pneumologie und Intensivmedizin der Medizinischen Klinik II, Uniklinik Gießen und Marburg Standort GießenRecruiting
- Krankenhaus Neuwittelsbach, Innere Medizin II
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Riciguat Group
Macitentan Group
Arm Description
15 PAH patients will be administered Riciguat according to standard of care. RV function will be evaluated 90 mintutes after first medication intake and 12 weeks after first medication intake.
15 PAH patients will be administered Macitentan according to standard of care. RV function will be evaluated 90 mintutes after first medication intake and 12 weeks after first medication intake.
Outcomes
Primary Outcome Measures
RV function
Evaluation of the therapeutic effect of both treatment groups as measured by the change in systolic and diastolic RV function within 12 weeks after starting medication to plan a larger Phase II study. Methods: RV Catheterisation and Conductance Catherterisation.
Secondary Outcome Measures
recruitability
The feasible to include 30 patients within 12 months will be assessed by descripitve statistic
feasibility to set up a larger phase II study
The feasibility to set up a larger phase II study with this study setting and design will be assessed by descripitve statistic
RV contractility
Percent change in RV contractility (= end-systolic elastance, EES), RV, Methods: RV Catheterisation and Conductance Catherterisation.
Collection of Adverse Events
number of participants with adverse events (all) assessed by CTCAE v4.0
Full Information
NCT ID
NCT03362047
First Posted
November 22, 2017
Last Updated
May 9, 2023
Sponsor
University of Giessen
Collaborators
Philipps University Marburg Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03362047
Brief Title
(RIGHT HEART III Study - Right Ventricular Hemodynamic Evaluation and Response to Treatment)
Acronym
RightHeartIII
Official Title
Untersuchung Des Einflusses PAH-spezifischer Medikation Auf Die rechtsventrikuläre Funktion Bei Patienten Mit Pulmonaler Arterieller Hypertonie (PAH) Unter Basalen Bedingungen
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Giessen
Collaborators
Philipps University Marburg Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pilot study to determine the therapeutic effect of two prarallel groups treated with either Riciguat or Macitentan, evaluated by the change in systolic and diastolic RV function within 12 weeks after first drug intake in order to plan a larger Phase II study.
Detailed Description
In this multi-center, randomized, open pilot study the therapeutic effect of two prarallel groups treated with either Riciguat or Macitentan shall be determined by evaluating the change in systolic and diastolic RV function within 12 weeks after first drug intake in order to plan a larger Phase II study.The method used to determine the RV function will be the "Conductance Method".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension (PAH)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Multicentre, randomized, prospective, open pilot study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Riciguat Group
Arm Type
Experimental
Arm Description
15 PAH patients will be administered Riciguat according to standard of care. RV function will be evaluated 90 mintutes after first medication intake and 12 weeks after first medication intake.
Arm Title
Macitentan Group
Arm Type
Experimental
Arm Description
15 PAH patients will be administered Macitentan according to standard of care. RV function will be evaluated 90 mintutes after first medication intake and 12 weeks after first medication intake.
Intervention Type
Drug
Intervention Name(s)
Riciguat Group
Intervention Description
Patients will be administered 12 weeks Riciguat
Intervention Type
Drug
Intervention Name(s)
Macitentan Group
Intervention Description
Patients will be administered 12 weeks Macitentan
Primary Outcome Measure Information:
Title
RV function
Description
Evaluation of the therapeutic effect of both treatment groups as measured by the change in systolic and diastolic RV function within 12 weeks after starting medication to plan a larger Phase II study. Methods: RV Catheterisation and Conductance Catherterisation.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
recruitability
Description
The feasible to include 30 patients within 12 months will be assessed by descripitve statistic
Time Frame
12 months
Title
feasibility to set up a larger phase II study
Description
The feasibility to set up a larger phase II study with this study setting and design will be assessed by descripitve statistic
Time Frame
24 months
Title
RV contractility
Description
Percent change in RV contractility (= end-systolic elastance, EES), RV, Methods: RV Catheterisation and Conductance Catherterisation.
Time Frame
12 weeks
Title
Collection of Adverse Events
Description
number of participants with adverse events (all) assessed by CTCAE v4.0
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female and male patients, 18 years ≤ age ≤ 85 years
Diagnosis of Pulmonary Hypertension Group 1 according to Nizza Definition (PAH) confirmed by invasive methods, WHO functional class II and III
Existing clinical need to repeat a right ventricular catheter examination (as recommended by the current "Kölner Konsensuskonferenz")
Ability to understand study goals and agree to study participation
Hemodynamic criteria of ventricular catheter examination:
Pulmonary vascular resistance (PVR)> 240 dyn x sec x cm-5
Mean Pulmonary Arterial Pressure (mPAP) ≥ 25 mmHg
Clinical need to receive treatment with a drug approved for the treatment of PAH for the first time
Potentially fertile women must agree to use highly effective methods of contraception, either through abstinence or the use of at least two methods of contraception from the date of consent until one month after the end of the study. An effective pregnancy protection consists in the combination of a hormonal contraceptive (oral, injectable or implant) and a barrier method (condom or diaphragm with a vaginal spermicide)
Written consent to the clinical trial
Exclusion Criteria:
Existing therapy with positive inotropic drugs such as Catecholamines (including norepinephrine, dobutamine, suprarenin)
Pregnancy or breastfeeding
General contraindication for examinations to be performed during the study
Hypersensitivity to the active substances or to a constituent of the study medication (in particular lactose and soya)
Simultaneous participation in another medical therapy study
Simultaneous participation in another non-drug study that would preclude participation in this study
Participation within one month after completing another therapy study
Heavy liver function disorders
Existing increase in liver aminotransferases (aspartate aminotransferase (AST) and / or alanine aminotransferase (ALT))> 3 × ULN
Systolic blood pressure <95 mmHg
Pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP)
anemia (Hb <10 g / dl)
Concomitant medication with potential interaction to macitentan and/or riociguat according to the IB
Severe kidney dysfunction
Severe hemoptysis
History of bronchial artery embolization
smoker
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tello Khodr, MD
Phone
+49-(0)641-985-56087
Email
Khodr.Tello@innere.med.uni-giessen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Werner Seeger, Prof
Phone
(06 41) 985-42354
Email
Werner.Seeger@innere.med.uni-giessen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Werner Seeger, Prof
Organizational Affiliation
University Gießen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik III für Innere Medizin Herzzentrum der Universität zu Köln
City
Cologne
ZIP/Postal Code
D-50973
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan Rosenkranz, Prof
Phone
+49 221 47832356
Email
stephan.rosenkranz@uk-koeln.de
First Name & Middle Initial & Last Name & Degree
Daniel Dumitrescu, MD
Phone
+49 221 47888377
Email
daniel.dumitrescu@uk-koeln.de
Facility Name
Abteilung Pneumologie und Intensivmedizin der Medizinischen Klinik II, Uniklinik Gießen und Marburg Standort Gießen
City
Gießen
ZIP/Postal Code
35392
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tello Khodr, Dr
Phone
+49-(0)641-985-56087
Email
khodr.tello@innere.med.uni-giessen.de
Facility Name
Krankenhaus Neuwittelsbach, Innere Medizin II
City
München
ZIP/Postal Code
80639
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanno Leuchte, Prof
Phone
+49 89/13 04-22 05
Email
prof.leuchte@krankenhaus-neuwittelsbach.de
First Name & Middle Initial & Last Name & Degree
Rainer Baumgartner, MD
Phone
+49 89/1304-2503,
Email
ph-ambulanz@krankenhaus-neuwittelsbach.de
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared on request
IPD Sharing Time Frame
Data will be shared after end of study without limitation
IPD Sharing Access Criteria
e-mail to: Khodr.Tello@innere.med.uni-giessen.de
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