Status:
COMPLETED
(RIGHT HEART III Study - Right Ventricular Hemodynamic Evaluation and Response to Treatment)
Lead Sponsor:
University of Giessen
Collaborating Sponsors:
Philipps University Marburg
Conditions:
Pulmonary Arterial Hypertension (PAH)
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 ...
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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2024
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03362047
Start Date
March 1 2018
End Date
August 14 2024
Last Update
March 30 2025
Active Locations (3)
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1
Klinik III für Innere Medizin Herzzentrum der Universität zu Köln
Cologne, Germany, D-50973
2
Abteilung Pneumologie und Intensivmedizin der Medizinischen Klinik II, Uniklinik Gießen und Marburg Standort Gießen
Giessen, Germany, 35392
3
Krankenhaus Neuwittelsbach, Innere Medizin II
München, Germany, 80639