Clinical trial NCT03362047: (RIGHT HEART III Study - Right Ventricular Hemodynamic Evaluation and Response to Treatment)
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Arterial Hypertension (PAH)
Lead sponsor: University of Giessen
Sponsor class: OTHER
Collaborators: name: Philipps University Marburg
First posted: 2017-12-05
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentre, randomized, prospective, open pilot study
Primary purpose: TREATMENT

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".

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

Primary outcomes:
measure: RV function
timeFrame: 12 weeks
Secondary outcomes:
measure: recruitability
timeFrame: 12 months
measure: feasibility to set up a larger phase II study
timeFrame: 24 months
measure: RV contractility
timeFrame: 12 weeks
measure: Collection of Adverse Events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Klinik III für Innere Medizin Herzzentrum der Universität zu Köln
city: Gießen
country: Germany
facility: Abteilung Pneumologie und Intensivmedizin der Medizinischen Klinik II, Uniklinik Gießen und Marburg Standort Gießen
city: München
country: Germany
facility: Krankenhaus Neuwittelsbach, Innere Medizin II
Study officials:
affiliation: University Gießen
name: Werner Seeger, Prof
role: PRINCIPAL_INVESTIGATOR
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