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COMPLETEDPHASE2

Pharmacodynamic Effects of Riociguat in Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction

Evaluation of the Pharmacodynamic Effects of Riociguat in Subjects With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction in a Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Study

NCT02744339•Medical University of Vienna

View on ClinicalTrials.gov

Summary

The primary objective of this study is to • Assess the pharmacodynamic profile of riociguat in subjects with symptomatic pulmonary hypertension and heart failure with preserved ejection fraction The secondary objectives of this study are to * Assess safety and tolerability of riociguat in this study population * Assess changes in dimensions of left and right ventricles and cardiac function parameters using cardiac magnetic resonance imaging

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•18 to \<80 years of age at the time of informed consent (The lower age limit may be higher if legally required in participating countries.)
•Postmenopausal women (i.e. last menstrual bleeding at least 2 years before randomization)
•Women with bilateral tubal ligation
•Women with bilateral ovariectomy
•A serum pregnancy test is negative at the pre-study visit, and The woman uses a combination of condoms and a safe and highly effective contraception method (hormonal contraception with implants or combined oral contraceptives, certain intrauterine devices) for the entire duration of the study.
•Able to understand and follow instructions and to participate in the study for its entire duration
•Written informed consent

Exclusion Criteria

•PH-HF-PEF defined as:
•* LVEF ≥50%, diagnosed by echocardiography or left heart catheterization (LHC) within 30 days before randomization
•* PAPmean ≥25 mmHg at rest, measured by RHC
•* PAWP \>15 mmHg at rest, measured by RHC
•Optimized therapy for hypertension
•The dose regimen of the background treatment must have been stable for \>30 days before randomization. Diuretic therapy must have been stable for ≥1 week.
•RHC results for the definite diagnosis of PH not older than 12 weeks at Visit 1. RHC must have been performed in the participating center under standardized conditions
•CMRI must be performed at Visit 1 (baseline) or must not be older than 12 weeks with all parameters measured as listed in Section 7.3.3
•PH in groups other than group 2.2 according to Dana Point classification.(4) In particular, PAH, CTEPH, and HF-REF must have been ruled out according to accepted diagnostic procedures and guidelines.
•Cardiac decompensation, with hospitalization or visit to the emergency department,
+29 more criteria

Locations (1)

Medical University of Vienna

Vienna, Austria

Key Dates

Start Date

March 1, 2016

Primary Completion Date

August 1, 2020

Completion Date

September 1, 2020

Last Updated

November 4, 2020

Enrollment

118

ACTUAL participants

Conditions

Hypertension, PulmonaryHeart Failure With Normal Ejection Fraction

Interventions

Riociguat

DRUG

Placebo

DRUG

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RECRUITINGNA

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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: November 4, 2020Data 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.

View ClinicalTrials.gov Terms and Conditions

Pharmacodynamic Effects of Riociguat in Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction

Inclusion Criteria

Exclusion Criteria

A Deep-Learning-Enabled Electrocardiogram for Detecting Pulmonary Hypertension

Functional Pulmonary Capillary Surface Area in BPA for CTEPH

Real-World Study of PADN for the Treatment of PAH

New Orleans Pulmonary Hypertension Biobank

Endtidal Carbon Dioxide for Earlier Detection of Pulmonary Hypertension

A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction