Pulmonary arterial Hypertension (PAH) MedDRA version: 21.1 Level: LLT Classification code 10037403 Term: Pulmonary hypertension NOS System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0 Level: LLT Classification code 10077729 Term: Pulmonary arterial hypertension WHO functi
Conditions
Interventions
Trade Name: Adempas®
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RIOCIGUAT
CAS Number: 625115-55-1
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number:
Sponsors
Justus Liebig Universität Gießen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Man or woman 18 to 85 years of age - Invasive confirmed diagnosis of pulmonary hypertension, group 1 according to the Nice Classificationto (PAH), WHO Functional Classes II and III - Clinical need to perform onece more the right heart catheterization, (according to the recommendation of the current Cologne Consensus Conference) - Ability to understand the study information and study objectives - Hemodynamic criteria: will be measured during right heart catheter examination: pulmonary vascular resistance (PVR) > 240dyn x sec x cm-5, mean pulmonary arterial pressure (mPAP) = 25mmHg - For clinical reasons, need to receive an approved drug for the treatment of PAH - Potentially child-bearing women must be able to practice highly effective methods of contraception, either by abstinence or by using at least two methods of gestational contraception from the date of consent to one month after the end of the study. Effective pregnancy protection consists of the combination of a hormonal contraceptive (oral, injectable or implant) and a barrier method (condom or diaphragm with a vaginal spermicide) - Signed informed consent form by the patient according to local regulations Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: - Treatment with positive inotropic drugs e.g. Catecholamine (incl. Noradrenaline, Dobutamin, Suprarenin) - Pregnancy or breastfeeding - General contraindications to perform scheduled examinations during the study - Hypersensitivity to the active substances or to a component of the study drugs (in particular lactose and soya) - Simultaneous participation in another drug therapy study, - Simultaneous participation in another non-drug study, which would oppose participation in this study - Participation within one month after completion of another therapy study - Severe hepatic impairment - Existing increase in liver aminotransferase values (aspartate aminotransferase (AST) and / or alanine aminotransferase (ALT))> 3 × ULN - Systolic blood pressure <95 mmHg at the beginning of treatment - Pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP) - anemia (Hb <10 g / dl) - Accompanying medication with potential interaction with macitentan and riociguat in accordance with the relevant information of the specialist information - Severe renal impairment - Severe hemoptysis - Bronchial artery embolisation in prehistory - Smokers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigation of the therapeutic effect of both 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.;Secondary Objective: Recruiting feasibility procentual Right ventricular contractility (end-systolic elastance = Ees) from baseline to 12 weeks Arterial elastance (Ee) Ratio Ees/Ea Maximum and minimum increase in right ventricular pressure curve Diastolic right ventricular function (Tau, EDPVR) Diastolic RV function via the fibrosis degree in MRT using late enhancement, T1 mapping preload recruitable stroke work, (PRSW) Swan-Ganz measurement: Heart-time volume, venous oxygen saturation, pulmonary arterial pressure, pulmonary capillary wedge pressure. EDV, ESV, SV, EF, strain Analysis of RV (not obligatory), RV and LV mass, RV EDV / LV EDV, Late enhancement Stiffness of the pulmonary artery, capacity of the pulmonary artery, elastance of the pulmonary artery, total power, oscillatory power, mean power EDP (end-diastolic pressure), ESP (endsystolic pressure) Heart rate Starling contractility-index 6-Minute Walk Test lung function Acquisition of Adverse Events ;Primary end point(s): please see E.2 Objectives of the Trial;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): please see E.2 Objectives of the Trial;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
Germany
Contacts
Public ContactMedizinische Klinik II
Uniklinik Gießen und Marburg Standort Gießen
Outcome results
None listed