Clinical trial NCT01065454: A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction
Official title: Randomized, Double Blind, Placebo Controlled, Parallel Group, Multi-center Study to Evaluate the Hemodynamic Effects of Riociguat (BAY 63-2521) as Well as Safety and Kinetics in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Hypertension, Pulmonary
Ventricular Dysfunction, Left
Keywords: Pulmonary Hypertension
Left ventricular dysfunction
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-02-09
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: Pharmacokinetics parameters were regarded as exploratory parameters. Adverse event data will be covered in Adverse events section.

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

Primary outcomes:
measure: Pulmonary Artery Mean Pressure (PAPmean) at Rest - Change From Baseline to Week 16
timeFrame: Baseline and visit 6 (16 weeks)
Secondary outcomes:
measure: Venous Oxygen Saturation (SvO2) - Change From Baseline to Week 16
timeFrame: Baseline and visit 6 (16 weeks)
measure: Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16
timeFrame: Baseline and visit 6 (16 weeks)
measure: Pulmonary Vascular Resistance Index (PVRi) - Change From Baseline to Week 16
timeFrame: Baseline and visit 6 (16 weeks)
measure: Systemic Vascular Resistance (SVR) - Change From Baseline to Week 16
timeFrame: Baseline and visit 6 (16 weeks)
measure: Systemic Vascular Resistance Index (SVRi) - Change From Baseline to Week 16
timeFrame: Baseline and visit 6 (16 weeks)
measure: Transpulmonary Pressure Gradient (TPG) - Change From Baseline to Week 16
timeFrame: Baseline and visit 6 (16 weeks)
measure: Pulmonary Capillary Wedge Pressure (PCWP) - Change From Baseline to Week 16
timeFrame: Baseline and visit 6 (16 weeks)
measure: Tricuspid Annular Plane Systolic Excursion (TAPSE) - Change From Baseline to Week 16
timeFrame: Baseline and visit 6 (16 weeks)
measure: Systolic Pulmonary Arterial Pressure (PAPsyst) - Change From Baseline to Week 16
timeFrame: Baseline and visit 6 (16 weeks)
measure: Left Ventricular Ejection Fraction (LVEF) - Change From Baseline to Week 16
timeFrame: Baseline and visit 6 (16 weeks)
measure: Left Ventricular End-systolic Volume (LVESV) - Change From Baseline to Week 16
timeFrame: Baseline and visit 6 (16 weeks)
measure: Left Ventricular End-diastolic Volume (LVEDV) - Change From Baseline to Week 16
timeFrame: Baseline and visit 6 (16 weeks)
measure: E-wave Deceleration Time - Change From Baseline to Week 16
timeFrame: Baseline and visit 6 (16 weeks)
measure: Ratio of Mitral Peak Velocity of Early Filling to Mitral Peak Velocity of Late Filling (E/A) - Change From Baseline to Week 16
timeFrame: Baseline and visit 6 (16 weeks)
measure: 6-minute Walking Distance (6MWD) - Change From Baseline to Week 16
timeFrame: Baseline and visit 6 (16 weeks)
measure: WHO (World Health Organization) Functional Class - Change From Baseline to Week 16
timeFrame: Baseline and visit 6 (16 weeks)
measure: Percentage of Participants With Clinical Worsening
timeFrame: At visit 6 (16 weeks)
measure: Borg CR 10 Scale - Change From Baseline to Week 16
timeFrame: Baseline and visit 6 (16 weeks)
measure: EQ-5D Utility Score - Change From Baseline to Week 16
timeFrame: Baseline and visit 6 (16 weeks)
measure: Minnesota Living With Heart Failure Questionnaire (MLHF) Score - Change From Baseline to Week 16
timeFrame: Baseline and visit 6 (16 weeks)
measure: Cystatin C - Change From Baseline to Week 16
timeFrame: Baseline and visit 6 (16 weeks)
measure: N-terminal Pro-brain Natriuretic Peptide (NT-pro BNP) - Change From Baseline to Week 16
timeFrame: Baseline and visit 6 (16 weeks)
measure: Troponin T - Change From Baseline to Week 16
timeFrame: Baseline and visit 6 (16 weeks)
measure: Asymmetric Dimethylarginine (ADMA) - Change From Baseline to Week 16
timeFrame: Baseline and visit 6 (16 weeks)
measure: Osteopontin - Change From Baseline to Week 16
timeFrame: Baseline and visit 6 (16 weeks)
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Torrance
country: United States
state: California
city: Westminster
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Iowa City
country: United States
state: Iowa
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Rochester
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Cincinnati
country: United States
state: Ohio
city: Fairfield
country: United States
state: Ohio
city: Falls Church
country: United States
state: Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: Sydney
country: Australia
state: New South Wales
city: Herston
country: Australia
state: Queensland
city: Melbourne
country: Australia
state: Victoria
city: Innsbruck
country: Austria
state: Tirol
city: Wien
country: Austria
city: Aalst
country: Belgium
city: Brussels
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Montreal
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Beijing
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Brno
country: Czechia
city: Olomouc
country: Czechia
city: Praha 2
country: Czechia
city: Praha 4
country: Czechia
city: Aarhus N
country: Denmark
city: Bron Cedex
country: France
city: Lille Cedex
country: France
city: Nantes
country: France
city: Pessac
country: France
city: Rouen
country: France
city: TOULOUSE cedex
country: France
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Augsburg
country: Germany
state: Bayern
city: Greifswald
country: Germany
state: Mecklenburg-Vorpommern
city: Köln
country: Germany
state: Nordrhein-Westfalen
city: Erfurt
country: Germany
state: Thüringen
city: Naples
country: Italy
state: Campania
city: Pavia
country: Italy
state: Lombardia
city: Nagoya
country: Japan
state: Aichi
city: Seto
country: Japan
state: Aichi
city: Ogaki
country: Japan
state: Gifu
city: Higashiibaraki
country: Japan
state: Ibaraki
city: Tsu
country: Japan
state: Mie
city: Sendai
country: Japan
state: Miyagi
city: Kita-ku, Osaka
country: Japan
state: Osaka
city: Osaka-shi
country: Japan
state: Osaka
city: Suita
country: Japan
state: Osaka
city: Kusatsu
country: Japan
state: Shiga
city: Sunto
country: Japan
state: Shizuoka
city: Arakawa-ku
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Tanabe
country: Japan
state: Wakayama
city: Amsterdam
country: Netherlands
city: Amsterdam
country: Netherlands
city: Nijmegen
country: Netherlands
city: Bydgoszcz
country: Poland
city: Gdansk
country: Poland
city: Warszawa
country: Poland
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: A Coruna
country: Spain
state: A Coruña
city: Majadahonda
country: Spain
state: Madrid
city: Palma
country: Spain
state: Palma De Mallorca
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Murcia
country: Spain
city: Valencia
country: Spain
city: Geneva
country: Switzerland
state: Genève
city: Lugano
country: Switzerland
state: Ticino
city: Zürich
country: Switzerland
city: Cambridge
country: United Kingdom
state: Cambridgeshire
city: London
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Ghio S, Bonderman D, Felix SB, Ghofrani HA, Michelakis ED, Mitrovic V, Oudiz RJ, Frey R, Roessig L, Semigran MJ. Left ventricular systolic dysfunction associated with pulmonary hypertension riociguat trial (LEPHT): rationale and design. Eur J Heart Fail. 2012 Aug;14(8):946-53. doi: 10.1093/eurjhf/hfs071. Epub 2012 Jun 20.
citation: Bonderman D, Ghio S, Felix SB, Ghofrani HA, Michelakis E, Mitrovic V, Oudiz RJ, Boateng F, Scalise AV, Roessig L, Semigran MJ; Left Ventricular Systolic Dysfunction Associated With Pulmonary Hypertension Riociguat Trial (LEPHT) Study Group. Riociguat for patients with pulmonary hypertension caused by systolic left ventricular dysfunction: a phase IIb double-blind, randomized, placebo-controlled, dose-ranging hemodynamic study. Circulation. 2013 Jul 30;128(5):502-11. doi: 10.1161/CIRCULATIONAHA.113.001458. Epub 2013 Jun 17.