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

Acute Hemodynamic Effects of Riociguat (BAY63-2521) in Patients With Pulmonary Hypertension Associated With Diastolic Heart Failure: A Randomized, Double-blind, Placebo-controlled, Single-dose Study in Three Ascending Dose Cohorts

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01172756

Acronym

DILATE

Enrollment

Registered

2010-07-30

Start date

2010-07-31

Completion date

2012-10-31

Last updated

2014-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Pulmonary, Ventricular Dysfunction, Left

Keywords

Pulmonary Hypertension, Left ventricular dysfunction

Brief summary

The aim of this study is to assess whether single oral doses of Riociguat safely improve the cardiovascular function in patients with pulmonary hypertension associated with left ventricular diastolic dysfunction

Interventions

DRUGPlacebo

single oral dose

DRUGRiociguat (BAY63-2521)

0.5 mg single oral dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Male and female patients with symptomatic pulmonary hypertension due to left ventricular diastolic dysfunction

Exclusion criteria

* Types of pulmonary hypertension other than group 2.2 of Dana Point Classification

Design outcomes

Primary

Measure	Time frame
Pulmonary artery mean pressure at rest	Peak change from baseline within 6 hours after a single dose of study drug

Secondary

Measure	Time frame
Adverse event collection	until 30 days after study drug treatment
Plasma concentrations to obtain pharmacokinetic profile of Riociguat	Within 24 hours after study drug treatment

Countries

Austria, Czechia, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026