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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 May 2023
• Main ID: NCT03362047
• Date of registration: 22/11/2017
• Prospective Registration: Yes
• Primary sponsor: University of Giessen
• Public title: (RIGHT HEART III Study - Right Ventricular Hemodynamic Evaluation and Response to Treatment) RightHeartIII
• Scientific title: Untersuchung Des Einflusses PAH-spezifischer Medikation Auf Die rechtsventrikuläre Funktion Bei Patienten Mit Pulmonaler Arterieller Hypertonie (PAH) Unter Basalen Bedingungen
• Date of first enrolment: March 1, 2018
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03362047
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Germany

Contacts

• Name: Werner Seeger, Prof
• Affiliation: University Gießen

• Name: Tello Khodr, MD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension (PAH)

Intervention(s)

Drug: Macitentan Group

Drug: Riciguat Group

Primary Outcome(s)

RV function [Time Frame: 12 weeks]

Secondary Outcome(s)

recruitability [Time Frame: 12 months]

RV contractility [Time Frame: 12 weeks]

feasibility to set up a larger phase II study [Time Frame: 24 months]

Collection of Adverse Events [Time Frame: 12 weeks]

Secondary ID(s)

2015-002835-17

250774

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Philipps University Marburg Medical Center