(RIGHT HEART III Study - Right Ventricular Hemodynamic Evaluation and Response to Treatment)

  • End date
    Jun 30, 2022
  • participants needed
  • sponsor
    University of Giessen
Updated on 26 January 2021


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.


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".

Condition Pulmonary Arterial Hypertension
Treatment Riciguat Group, Macitentan Group
Clinical Study IdentifierNCT03362047
SponsorUniversity of Giessen
Last Modified on26 January 2021


Yes No Not Sure

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 "Klner 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
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