A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction
LEPHT
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
3 other identifiers
interventional
202
17 countries
80
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2010
Longer than P75 for phase_2
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2010
CompletedFirst Posted
Study publicly available on registry
February 9, 2010
CompletedStudy Start
First participant enrolled
April 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2012
CompletedResults Posted
Study results publicly available
December 25, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 23, 2025
CompletedAugust 28, 2025
August 1, 2025
2.1 years
February 8, 2010
November 6, 2013
August 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pulmonary Artery Mean Pressure (PAPmean) at Rest - Change From Baseline to Week 16
Mean pulmonary arterial pressure (PAPmean) is a directly measured hemodynamic parameter. PAPmean is recorded during a right heart catheterization.
Baseline and visit 6 (16 weeks)
Secondary Outcomes (25)
Venous Oxygen Saturation (SvO2) - Change From Baseline to Week 16
Baseline and visit 6 (16 weeks)
Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16
Baseline and visit 6 (16 weeks)
Pulmonary Vascular Resistance Index (PVRi) - Change From Baseline to Week 16
Baseline and visit 6 (16 weeks)
Systemic Vascular Resistance (SVR) - Change From Baseline to Week 16
Baseline and visit 6 (16 weeks)
Systemic Vascular Resistance Index (SVRi) - Change From Baseline to Week 16
Baseline and visit 6 (16 weeks)
- +20 more secondary outcomes
Study Arms (4)
Riociguat (Adempas, BAY63-2521) up to 2 mg
EXPERIMENTALParticipants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
Riociguat (Adempas, BAY63-2521) up to 1 mg
EXPERIMENTALParticipants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
Riociguat (Adempas, BAY63-2521) fixed 0.5 mg
EXPERIMENTALParticipants received riociguat 0.5 mg tid (fixed dose).
Placebo
PLACEBO COMPARATORParticipants received placebo tid.
Interventions
up to 2 mg three times a day (increasing from 0.5 to 1 to 2 mg)
Eligibility Criteria
You may qualify if:
- Male and female patients with symptomatic pulmonary hypertension due to left ventricular systolic dysfunction despite optimized heart failure therapy
You may not qualify if:
- Types of pulmonary hypertension other than group 2.1 of Dana Point Classification
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (83)
Unknown Facility
Los Angeles, California, 90073-1003, United States
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San Diego, California, 92103, United States
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Torrance, California, 90502, United States
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Westminster, California, 92683, United States
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Miami, Florida, 33136, United States
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Iowa City, Iowa, 52242, United States
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Baltimore, Maryland, 21201, United States
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Boston, Massachusetts, 02114-2696, United States
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Rochester, Minnesota, 55905, United States
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St Louis, Missouri, 63110, United States
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Cincinnati, Ohio, 45219, United States
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Fairfield, Ohio, 45014, United States
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Falls Church, Virginia, 22042, United States
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Milwaukee, Wisconsin, 53215, United States
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Sydney, New South Wales, 2010, Australia
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Herston, Queensland, 4029, Australia
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Melbourne, Victoria, 3004, Australia
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Innsbruck, Tyrol, 6020, Austria
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Vienna, 1090, Austria
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Aalst, 9300, Belgium
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Brussels, 1070, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Edmonton, Alberta, T6G 2B7, Canada
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Vancouver, British Columbia, V5Z 1M9, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Québec, G1V 4G5, Canada
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Beijing, 100020, China
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Shanghai, 200032, China
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Shanghai, 200433, China
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Brno, 656 91, Czechia
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Olomouc, 77900, Czechia
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Prague, 12808, Czechia
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Prague, 140 21, Czechia
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Aarhus N, 8200, Denmark
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Bron, 69677, France
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Lille, 59037, France
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Nantes, 44035, France
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Pessac, 33604, France
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Rouen, 76031, France
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Toulouse, 31059, France
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Heidelberg, Baden-Wurttemberg, 69115, Germany
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Augsburg, Bavaria, 86156, Germany
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Greifswald, Mecklenburg-Vorpommern, 17475, Germany
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Cologne, North Rhine-Westphalia, 50937, Germany
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Erfurt, Thuringia, 99089, Germany
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Naples, Campania, 80131, Italy
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Pavia, Lombardy, 27100, Italy
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Nagoya, Aichi-ken, 466-8560, Japan
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Seto, Aichi-ken, 489-8642, Japan
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Ōgaki, Gifu, 503-8502, Japan
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Higashiibaraki, Ibaraki, 311-3193, Japan
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Tsu, Mie-ken, 514-1101, Japan
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Sendai, Miyagi, 980-8574, Japan
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Kita-ku, Osaka, Osaka, 530-8480, Japan
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Osaka, Osaka, 541-8567, Japan
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Suita, Osaka, 565-0871, Japan
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Kusatsu, Shiga, 525-8585, Japan
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Sunto, Shizuoka, 411-8611, Japan
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Arakawa-ku, Tokyo, 116-8567, Japan
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Shinjuku-ku, Tokyo, 162-8666, Japan
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Tanabe, Wakayama, 646-8558, Japan
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Amsterdam, 1081 HV, Netherlands
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Amsterdam, 1091 AC, Netherlands
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Nijmegen, 6525 GA, Netherlands
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Bydgoszcz, 85-168, Poland
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Gdansk, 80-214, Poland
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Warsaw, 04-628, Poland
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Singapore, 119074, Singapore
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Singapore, 169609, Singapore
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Singapore, 308433, Singapore
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A Coruña, A Coruña, 15006, Spain
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Majadahonda, Madrid, 28222, Spain
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Palma, Palma de Mallorca, 7198, Spain
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Barcelona, 08003, Spain
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Madrid, 28041, Spain
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Murcia, 30120, Spain
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Valencia, 46026, Spain
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Geneva, Canton of Geneva, 1205, Switzerland
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Lugano, Canton Ticino, 6900, Switzerland
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Zurich, 8091, Switzerland
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Cambridge, Cambridgeshire, CB2 0AY, United Kingdom
Unknown Facility
London, SW3 6NP, United Kingdom
Related Publications (2)
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.
PMID: 22719060RESULTBonderman 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.
PMID: 23775260RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Subjects had advanced disease and were heavily pretreated. Baseline values were not comparable between treatment groups.
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2010
First Posted
February 9, 2010
Study Start
April 14, 2010
Primary Completion
June 6, 2012
Study Completion
July 23, 2025
Last Updated
August 28, 2025
Results First Posted
December 25, 2013
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.