Trial Condition(s):
Hypertension, Pulmonary, Ventricular Dysfunction, Left
A study to test the effects of Riociguat in patients with pulmonary hypertension associated with left ventricular systolic dysfunction (LEPHT)
Bayer Identifier:
14308
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
2023-507001-34-00
Trial Purpose
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
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Heidelberg, Germany, 69115 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Augsburg, Germany, 86156 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Cambridge, United Kingdom, CB23 3RE | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Rochester, United States, 55905 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Torrance, United States, 90502 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Greifswald, Germany, 17475 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Köln, Germany, 50937 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Erfurt, Germany, 99089 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Saint Louis, United States, 63110 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site San Diego, United States, 92103-8466 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Falls Church, United States, 22042 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Boston, United States, 02114-2696 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Fairfield, United States, 45014 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Miami, United States, 33136 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Nantes, France, 44035 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site TOULOUSE cedex, France, 31059 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Rouen, France, 76031 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Sendai, Japan, 980-8574 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Tsu, Japan, 514-1101 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Osaka-shi, Japan, 541-8567 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Kita-ku, Osaka, Japan, 530-8480 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Naples, Italy, 80131 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Barcelona, Spain, 08003 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Valencia, Spain, 46026 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Palma, Spain, 7198 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Quebec, Canada, G1V 4G5 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Lille Cedex, France, 59037 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Bydgoszcz, Poland, 85-168 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Sunto, Japan, 411-8611 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Nagoya, Japan, 466-8560 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Kusatsu, Japan, 525-8585 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Suita, Japan, 565-0871 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Madrid, Spain, 28041 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Majadahonda, Spain, 28222 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Edmonton, Canada, T6G 2B7 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Vancouver, Canada, V5Z 1M9 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Brussels, Belgium, 1070 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Montreal, Canada, H3T 1E2 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site AMSTERDAM, Netherlands, 1081 HV | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Aarhus N, Denmark, 8200 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Sydney, Australia, 2010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Melbourne, Australia, 3004 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Herston, Australia, 4029 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Innsbruck, Austria, 6020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Zürich, Switzerland, 8091 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Lugano, Switzerland, 6900 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Singapore, Singapore, 308433 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Singapore, Singapore, 119074 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Singapore, Singapore, 169609 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Murcia, Spain, 30120 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site A Coruna, Spain, 15006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Geneva, Switzerland, 1205 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Cincinnati, United States, 45219 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site BRON CEDEX, France, 69677 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site PESSAC, France, 33604 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Beijing, China, 100020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Shanghai, China, 200032 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site shanghai, China, 200433 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Westminster, United States, 92683 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site NIJMEGEN, Netherlands, 6525 GA | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Baltimore, United States, 21201 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Los Angeles, United States, 90073-1003 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Iowa City, United States, 52242 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Seto, Japan, 489-8642 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site GENT, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Shinjuku-ku, Japan, 162-8666 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Arakawa-ku, Japan, 116-8567 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Higashiibaraki, Japan, 311-3193 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Milwaukee, United States, 53215 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Aalst, Belgium, 9300 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site London, United Kingdom, SW3 6NP | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Praha 4, Czech Republic, 140 21 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Praha 2, Czech Republic, 12808 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Brno, Czech Republic, 656 91 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Olomouc, Czech Republic, 77900 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Warszawa, Poland, 04-628 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Ogaki, Japan, 503-8502 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Tanabe, Japan, 646-8558 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Gdansk, Poland, 80-214 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site AMSTERDAM, Netherlands, 1091 AC | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
4
Primary Outcome
- Pulmonary artery mean pressure (PAPmean) at rest - Change from baseline to week 16Timeframe: Baseline and visit 6 (16 weeks)
Secondary Outcome
- Venous oxygen saturation (SvO2) - Change from baseline to week 16Timeframe: Baseline and visit 6 (16 weeks)
- Pulmonary vascular resistance (PVR) - Change from baseline to week 16Timeframe: Baseline and visit 6 (16 weeks)
- Pulmonary vascular resistance index (PVRi) - Change from baseline to week 16Timeframe: Baseline and visit 6 (16 weeks)
- Systemic vascular resistance (SVR) - Change from baseline to week 16Timeframe: Baseline and visit 6 (16 weeks)
- Systemic vascular resistance index (SVRi) - Change from baseline to week 16Timeframe: Baseline and visit 6 (16 weeks)
- Transpulmonary pressure gradient (TPG) - Change from baseline to week 16Timeframe: Baseline and visit 6 (16 weeks)
- Pulmonary capillary wedge pressure (PCWP) - Change from baseline to week 16Timeframe: Baseline and visit 6 (16 weeks)
- Tricuspid annular plane systolic excursion (TAPSE) - Change from baseline to week 16Timeframe: Baseline and visit 6 (16 weeks)
- Systolic pulmonary arterial pressure (PAPsyst) - Change from baseline to week 16Timeframe: Baseline and visit 6 (16 weeks)
- Left ventricular ejection fraction (LVEF) - Change from baseline to week 16Timeframe: Baseline and visit 6 (16 weeks)
- Left ventricular end-systolic volume (LVESV) - Change from baseline to week 16Timeframe: Baseline and visit 6 (16 weeks)
- Left ventricular end-diastolic volume (LVEDV) - Change from baseline to week 16Timeframe: Baseline and visit 6 (16 weeks)
- E-wave deceleration time - Change from baseline to week 16Timeframe: Baseline and visit 6 (16 weeks)
- Ratio of mitral peak velocity of early filling to mitral peak velocity of late filling (E/A) - Change from baseline to week 16Timeframe: Baseline and visit 6 (16 weeks)
- 6-minute walking distance (6MWD) - Change from baseline to week 16Timeframe: Baseline and visit 6 (16 weeks)
- WHO (World Health Organization) functional class - Change from baseline to week 16Timeframe: Baseline and visit 6 (16 weeks)
- Percentage of particpants with clinical worseningTimeframe: At visit 6 (16 weeks)
- Borg CR 10 Scale - Change from baseline to week 16Timeframe: Baseline and visit 6 (16 weeks)
- EQ-5D utility score - Change from baseline to week 16Timeframe: Baseline and visit 6 (16 weeks)
- Minnesota Living with Heart Failure Questionnaire (MLHF) score - Change from baseline to week 16Timeframe: Baseline and visit 6 (16 weeks)
- Cystatin C - Change from baseline to week 16Timeframe: Baseline and visit 6 (16 weeks)
- N-terminal pro-brain natriuretic peptide (NT-pro BNP) - Change from baseline to week 16Timeframe: Baseline and visit 6 (16 weeks)
- Troponin T - Change from baseline to week 16Timeframe: Baseline and visit 6 (16 weeks)
- Asymmetric dimethylarinine (ADMA) - Change from baseline to week 16Timeframe: Baseline and visit 6 (16 weeks)
- Osteopontin - Change from baseline to week 16Timeframe: Baseline and visit 6 (16 weeks)
Additional Information
Not Available
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