NCT03362047CompletedPhase 2
(RIGHT HEART III Study - Right Ventricular Hemodynamic Evaluation and Response to Treatment)
Untersuchung Des Einflusses PAH-spezifischer Medikation Auf Die rechtsventrikuläre Funktion Bei Patienten Mit Pulmonaler Arterieller Hypertonie (PAH) Unter Basalen Bedingungen
Source: ClinicalTrials.gov · Last updated 30 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 7 (actual)
- First submitted
- 22 Nov 2017
- Start date
- 1 Mar 2018
- Primary completion date
- 3 Jul 2024
- Lead sponsor
- University of Giessen
- NCT number
- NCT03362047
- EudraCT number
- 2015-002835-17
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 7
- From 1 Mar 2018 to the primary completion date, 3 Jul 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Existing therapy with positive inotropic drugs such as Catecholamines (including norepinephrine, dobutamine, suprarenin)
- 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
- Concomitant medication with potential interaction to macitentan and/or riociguat according to the IB
Other illness
- Hypersensitivity to the active substances or to a constituent of the study medication (in particular lactose and soya)
- Heavy liver function disorders
- Pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP)
- History of bronchial artery embolization
Lab values
- Existing increase in liver aminotransferases (aspartate aminotransferase (AST) and / or alanine aminotransferase (ALT))\> 3 × ULN
Other
- Pregnancy or breastfeeding
- General contraindication for examinations to be performed during the study
- Systolic blood pressure \<95 mmHg
- anemia (Hb \<10 g / dl)
- Severe kidney dysfunction
- Severe hemoptysis
- smoker
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Klinik III für Innere Medizin Herzzentrum der Universität zu Köln Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| Abteilung Pneumologie und Intensivmedizin der Medizinischen Klinik II, Uniklinik Gießen und Marburg Standort Gießen Coordinator of this site? Confirm its status | Giessen | Germany | Unknown status |
| Krankenhaus Neuwittelsbach, Innere Medizin II Coordinator of this site? Confirm its status | München | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.