Phase 2 N=201 Randomized Quadruple-blind Treatment

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

Hypertension, Pulmonary · Ventricular Dysfunction, Left

Bottom Line

View on ClinicalTrials.gov: NCT01065454 ↗

Enrolled (actual)

201

Serious AEs

27.4%

Results posted

Dec 2013

Primary outcome: Primary: Pulmonary Artery Mean Pressure (PAPmean) at Rest - Change From Baseline to Week 16 — -6.1; -0.8; -4.5; -4.0 mmHg — p=0.1044

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Riociguat (Adempas, BAY63-2521) (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bayer
Primary completion: Jun 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Pulmonary Artery Mean Pressure (PAPmean) at Rest - Change From Baseline to Week 16	-6.1; -0.8; -4.5; -4.0	0.1044
SECONDARY Venous Oxygen Saturation (SvO2) - Change From Baseline to Week 16	1.98; 0.46; -0.21; 1.28	—
SECONDARY Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16	-78.15; -33.05; -51.44; -36.97	—
SECONDARY Pulmonary Vascular Resistance Index (PVRi) - Change From Baseline to Week 16	-152.60; -61.763; -91.65; -76.47	—
SECONDARY Systemic Vascular Resistance (SVR) - Change From Baseline to Week 16	-340.44; -118.72; -67.46; -94.37	—
SECONDARY Systemic Vascular Resistance Index (SVRi) - Change From Baseline to Week 16	-651.98; -217.14; -100.31; -195.11	—
SECONDARY Transpulmonary Pressure Gradient (TPG) - Change From Baseline to Week 16	-2.16; -1.01; -1.65; -1.37	—
SECONDARY Pulmonary Capillary Wedge Pressure (PCWP) - Change From Baseline to Week 16	-3.93; 0.25; -2.818; -2.68	—
SECONDARY Tricuspid Annular Plane Systolic Excursion (TAPSE) - Change From Baseline to Week 16	0.584; 1.140; 0.304; 0.393	—
SECONDARY Systolic Pulmonary Arterial Pressure (PAPsyst) - Change From Baseline to Week 16	-7.69; -2.89; -5.86; -4.49	—
SECONDARY Left Ventricular Ejection Fraction (LVEF) - Change From Baseline to Week 16	6.599; 12.659; 5.529; 11.121	—
SECONDARY Left Ventricular End-systolic Volume (LVESV) - Change From Baseline to Week 16	1.805; 6.415; 1.507; 7.295	—
SECONDARY Left Ventricular End-diastolic Volume (LVEDV) - Change From Baseline to Week 16	6.599; 12.659; 5.529; 11.121	—
SECONDARY E-wave Deceleration Time - Change From Baseline to Week 16	2.857; -0.636; 8.000; -1.208	—
SECONDARY Ratio of Mitral Peak Velocity of Early Filling to Mitral Peak Velocity of Late Filling (E/A) - Change From Baseline to Week 16	-0.247; 0.141; -0.063; -0.175	—
SECONDARY 6-minute Walking Distance (6MWD) - Change From Baseline to Week 16	31.425; 25.379; -2.784; 17.857	—
SECONDARY WHO (World Health Organization) Functional Class - Change From Baseline to Week 16	20.4; 21.4; 22.7; 19.6; 74.1; 75	—
SECONDARY Percentage of Participants With Clinical Worsening	23.9; 15.1; 15.6; 21.7	—
SECONDARY Borg CR 10 Scale - Change From Baseline to Week 16	0.269; -0.804; -0.682; 0.187	—
SECONDARY EQ-5D Utility Score - Change From Baseline to Week 16	0.073; 0.016; 0.004; 0.018	—
SECONDARY Minnesota Living With Heart Failure Questionnaire (MLHF) Score - Change From Baseline to Week 16	-10.789; -5.132; -7.595; 0.211	—
SECONDARY Cystatin C - Change From Baseline to Week 16	39.3; 11.2; 71.2; 58.6	—
SECONDARY N-terminal Pro-brain Natriuretic Peptide (NT-pro BNP) - Change From Baseline to Week 16	-168.42; -213.48; -215.71; 171.51	—
SECONDARY Troponin T - Change From Baseline to Week 16	0.005; -0.008; -0.001; 0.003	—
SECONDARY Asymmetric Dimethylarginine (ADMA) - Change From Baseline to Week 16	0.020; 0.026; 0.006; 0.020	—
SECONDARY Osteopontin - Change From Baseline to Week 16	-13.400; -0.852; -2.722; -4.588	—

Summary

The aim of this study is to assess whether increasing oral doses of Riociguat are safe and improve the well-being, symptoms and outcome in patients with pulmonary hypertension associated with left ventricular systolic dysfunction

Eligibility Criteria

Inclusion Criteria

Male and female patients with symptomatic pulmonary hypertension due to left ventricular systolic dysfunction despite optimized heart failure therapy

Exclusion Criteria

Types of pulmonary hypertension other than group 2.1 of Dana Point Classification

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01065454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.