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

• Register: EUCTR
• Last refreshed on: 17 January 2022
• Main ID: EUCTR2015-002835-17-DE
• Date of registration: 26/11/2015
• Prospective Registration: Yes
• Primary sponsor: Justus Liebig Universität Gießen
• Public title: RIGHT HEART III Study – Right ventricular hemodynamic evaluation and response to treatment
• Scientific title: Investigation of the influence of PAH-specific medication on right ventricular function in patients with pulmonary arterial hypertension (PAH) under basal conditions - RIGHT HEART III
• Date of first enrolment: 18/01/2016
• Target sample size: 30
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002835-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Germany

Contacts

• Name: Medizinische Klinik II
• Affiliation: Uniklinik Gießen und Marburg Standort Gießen

• Name: Medizinische Klinik II
• Affiliation: Uniklinik Gießen und Marburg Standort Gießen

Key inclusion & exclusion 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:
- 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





Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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 functional class III System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0 Level: LLT Classification code 10077740 Term: Pulmonary arterial hypertension WHO functional class II System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

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: 7,5-

Trade Name: Opsumit®
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: MACITENTAN
CAS Number: 441798-33-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 12 weeks

Primary end point(s): please see E.2 Objectives of the Trial

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

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 Outcome(s)

Secondary end point(s): please see E.2 Objectives of the Trial

Timepoint(s) of evaluation of this end point: 12 weeks

Secondary ID(s)

250774

Source(s) of Monetary Support

Justus Liebig Universität Gießen

Ethics review

Status: Approved
Approval date: 22/12/2015
Contact: