Clinical Trials

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 85 Years
Gender	All

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03362047
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Giessen
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Werner Seeger, Prof
Principal Investigator Affiliation	University Gießen
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Germany
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Arterial Hypertension (PAH)

Additional Details

In this multi-center, randomized, open pilot study the therapeutic effect of two prarallel groups treated with either Riciguat or Macitentan shall be determined by evaluating the change in systolic and diastolic RV function within 12 weeks after first drug intake in order to plan a larger Phase II study.The method used to determine the RV function will be the "Conductance Method".

Arms & Interventions

Arms

Experimental: Riciguat Group

15 PAH patients will be administered Riciguat according to standard of care. RV function will be evaluated 90 mintutes after first medication intake and 12 weeks after first medication intake.

Experimental: Macitentan Group

15 PAH patients will be administered Macitentan according to standard of care. RV function will be evaluated 90 mintutes after first medication intake and 12 weeks after first medication intake.

Interventions

Drug: - Riciguat Group

Patients will be administered 12 weeks Riciguat

Drug: - Macitentan Group

Patients will be administered 12 weeks Macitentan

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.