RIGHT HEART III Study – Right ventricular hemodynamic evaluation and response to treatment

Phase 1

• Conditions: Pulmonary arterial Hypertension (PAH); MedDRA version: 21.1Level: LLTClassification code 10037403Term: Pulmonary hypertension NOSSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 20.0Level: LLTClassification code 10077729Term: Pulmonary arterial hypertension WHO functional class IIISystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 20.0Level: LLTClassification code 10077740Term: Pulmonary arterial hypertension WHO functional class IISystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-002835-17-DE
• Lead Sponsor: Justus Liebig Universität Gießen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified