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(RIGHT HEART III Study - Right Ventricular Hemodynamic Evaluation and Response to Treatment) | Clinical Trials | Clareo Health

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(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

NCT03362047•University of Giessen

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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".

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

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
+7 more criteria

Locations (3)

Klinik III für Innere Medizin Herzzentrum der Universität zu Köln

Cologne, Germany

Abteilung Pneumologie und Intensivmedizin der Medizinischen Klinik II, Uniklinik Gießen und Marburg Standort Gießen

Giessen, Germany

Krankenhaus Neuwittelsbach, Innere Medizin II

München, Germany

Key Dates

Start Date

March 1, 2018

Primary Completion Date

July 3, 2024

Completion Date

August 14, 2024

Last Updated

March 30, 2025

Enrollment

ACTUAL participants

Conditions

Pulmonary Arterial Hypertension (PAH)

Interventions

Riciguat Group

DRUG

Macitentan Group

DRUG

COMPERA / COMPERA-KIDS

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

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