Abstract | BACKGROUND: METHODS AND RESULTS: Overall, 201 patients with heart failure resulting from pulmonary hypertension caused by systolic left ventricular dysfunction were randomized to double-blind treatment with oral placebo or riociguat (0.5, 1, or 2 mg 3 times daily) for 16 weeks in 4 parallel arms. The primary outcome was the placebo-corrected change from baseline at week 16 in mean pulmonary artery pressure. Although the decrease in mean pulmonary artery pressure in the riociguat 2 mg group (-6.1±1.3 mm Hg; P<0.0001 versus baseline) was not significantly different from placebo (P=0.10), cardiac index (0.4 L·min(-1)·m(-2); 95% confidence interval, 0.2-0.5; P=0.0001) and stroke volume index (5.2 mL·m(-2); 95% confidence interval, 2.0-8.4; P=0.0018) were significantly increased without changes in heart rate or systemic blood pressure compared with placebo. Both pulmonary (-46.6 dynes·s(-1)·cm(-5); 95% confidence interval, -89.4 to -3.8; P=0.03) and systemic vascular resistance (-239.3 dynes·s(-1)·cm(-5); 95% confidence interval, -363.4 to -115.3; P=0.0002) were significantly reduced with riociguat 2 mg. Riociguat reduced the Minnesota Living With Heart Failure score (P=0.0002). Discontinuation of treatment was similar between treatment groups. CONCLUSIONS: CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01065454.
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Authors | Diana Bonderman, Stefano Ghio, Stephan B Felix, Hossein-Ardeschir Ghofrani, Evangelos Michelakis, Veselin Mitrovic, Ronald J Oudiz, Francis Boateng, Andrea-Viviana Scalise, Lothar Roessig, Marc J Semigran, Left Ventricular Systolic Dysfunction Associated With Pulmonary Hypertension Riociguat Trial (LEPHT) Study Group |
Journal | Circulation
(Circulation)
Vol. 128
Issue 5
Pg. 502-11
(Jul 30 2013)
ISSN: 1524-4539 [Electronic] United States |
PMID | 23775260
(Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Pyrazoles
- Pyrimidines
- riociguat
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Topics |
- Adult
- Aged
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Hemodynamics
(drug effects, physiology)
- Humans
- Hypertension, Pulmonary
(drug therapy, epidemiology)
- Male
- Middle Aged
- Pyrazoles
(therapeutic use)
- Pyrimidines
(therapeutic use)
- Ventricular Dysfunction, Left
(drug therapy, epidemiology)
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