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Original Article

Riociguat for Patients With Pulmonary Hypertension Caused by Systolic Left Ventricular DysfunctionClinical Perspective

A Phase IIb Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Hemodynamic Study

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
and on behalf of the Left Ventricular Systolic Dysfunction Associated With Pulmonary Hypertension Riociguat Trial (LEPHT) Study Group
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https://doi.org/10.1161/CIRCULATIONAHA.113.001458
Circulation. 2013;128:502-511
Originally published July 29, 2013
Diana Bonderman
From the Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria (D.B.); Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, University Hospital, Pavia, Italy (S.G.); Department of Cardiology and Internal Medicine B, University Medicine Greifswald, and DZHK (German Centre for Cardiovascular Research), Greifswald, Germany (S.B.F.); University of Giessen and Marburg Lung Center, and German Center of Lung Research, Giessen, Germany (H.-A.G.); Department of Medicine, University of Alberta, Edmonton, AB, Canada (E.M.); Kerckhoff-Klinik Forschungsgesellschaft GmbH, Bad Nauheim, Germany (V.M.); Los Angeles Biomedical Research Institute at Harbor–UCLA Medical Center, Torrance, CA (R.J.O.); Bayer HealthCare Pharmaceuticals, New York, NY (F.B.); Bayer Hispania, Barcelona, Spain (A.-V.S.); Bayer Pharma AG, Berlin, Germany (L.R.); and Cardiology Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA (M.J.S.).
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Stefano Ghio
From the Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria (D.B.); Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, University Hospital, Pavia, Italy (S.G.); Department of Cardiology and Internal Medicine B, University Medicine Greifswald, and DZHK (German Centre for Cardiovascular Research), Greifswald, Germany (S.B.F.); University of Giessen and Marburg Lung Center, and German Center of Lung Research, Giessen, Germany (H.-A.G.); Department of Medicine, University of Alberta, Edmonton, AB, Canada (E.M.); Kerckhoff-Klinik Forschungsgesellschaft GmbH, Bad Nauheim, Germany (V.M.); Los Angeles Biomedical Research Institute at Harbor–UCLA Medical Center, Torrance, CA (R.J.O.); Bayer HealthCare Pharmaceuticals, New York, NY (F.B.); Bayer Hispania, Barcelona, Spain (A.-V.S.); Bayer Pharma AG, Berlin, Germany (L.R.); and Cardiology Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA (M.J.S.).
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Stephan B. Felix
From the Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria (D.B.); Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, University Hospital, Pavia, Italy (S.G.); Department of Cardiology and Internal Medicine B, University Medicine Greifswald, and DZHK (German Centre for Cardiovascular Research), Greifswald, Germany (S.B.F.); University of Giessen and Marburg Lung Center, and German Center of Lung Research, Giessen, Germany (H.-A.G.); Department of Medicine, University of Alberta, Edmonton, AB, Canada (E.M.); Kerckhoff-Klinik Forschungsgesellschaft GmbH, Bad Nauheim, Germany (V.M.); Los Angeles Biomedical Research Institute at Harbor–UCLA Medical Center, Torrance, CA (R.J.O.); Bayer HealthCare Pharmaceuticals, New York, NY (F.B.); Bayer Hispania, Barcelona, Spain (A.-V.S.); Bayer Pharma AG, Berlin, Germany (L.R.); and Cardiology Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA (M.J.S.).
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Hossein-Ardeschir Ghofrani
From the Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria (D.B.); Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, University Hospital, Pavia, Italy (S.G.); Department of Cardiology and Internal Medicine B, University Medicine Greifswald, and DZHK (German Centre for Cardiovascular Research), Greifswald, Germany (S.B.F.); University of Giessen and Marburg Lung Center, and German Center of Lung Research, Giessen, Germany (H.-A.G.); Department of Medicine, University of Alberta, Edmonton, AB, Canada (E.M.); Kerckhoff-Klinik Forschungsgesellschaft GmbH, Bad Nauheim, Germany (V.M.); Los Angeles Biomedical Research Institute at Harbor–UCLA Medical Center, Torrance, CA (R.J.O.); Bayer HealthCare Pharmaceuticals, New York, NY (F.B.); Bayer Hispania, Barcelona, Spain (A.-V.S.); Bayer Pharma AG, Berlin, Germany (L.R.); and Cardiology Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA (M.J.S.).
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Evangelos Michelakis
From the Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria (D.B.); Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, University Hospital, Pavia, Italy (S.G.); Department of Cardiology and Internal Medicine B, University Medicine Greifswald, and DZHK (German Centre for Cardiovascular Research), Greifswald, Germany (S.B.F.); University of Giessen and Marburg Lung Center, and German Center of Lung Research, Giessen, Germany (H.-A.G.); Department of Medicine, University of Alberta, Edmonton, AB, Canada (E.M.); Kerckhoff-Klinik Forschungsgesellschaft GmbH, Bad Nauheim, Germany (V.M.); Los Angeles Biomedical Research Institute at Harbor–UCLA Medical Center, Torrance, CA (R.J.O.); Bayer HealthCare Pharmaceuticals, New York, NY (F.B.); Bayer Hispania, Barcelona, Spain (A.-V.S.); Bayer Pharma AG, Berlin, Germany (L.R.); and Cardiology Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA (M.J.S.).
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Veselin Mitrovic
From the Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria (D.B.); Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, University Hospital, Pavia, Italy (S.G.); Department of Cardiology and Internal Medicine B, University Medicine Greifswald, and DZHK (German Centre for Cardiovascular Research), Greifswald, Germany (S.B.F.); University of Giessen and Marburg Lung Center, and German Center of Lung Research, Giessen, Germany (H.-A.G.); Department of Medicine, University of Alberta, Edmonton, AB, Canada (E.M.); Kerckhoff-Klinik Forschungsgesellschaft GmbH, Bad Nauheim, Germany (V.M.); Los Angeles Biomedical Research Institute at Harbor–UCLA Medical Center, Torrance, CA (R.J.O.); Bayer HealthCare Pharmaceuticals, New York, NY (F.B.); Bayer Hispania, Barcelona, Spain (A.-V.S.); Bayer Pharma AG, Berlin, Germany (L.R.); and Cardiology Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA (M.J.S.).
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Ronald J. Oudiz
From the Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria (D.B.); Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, University Hospital, Pavia, Italy (S.G.); Department of Cardiology and Internal Medicine B, University Medicine Greifswald, and DZHK (German Centre for Cardiovascular Research), Greifswald, Germany (S.B.F.); University of Giessen and Marburg Lung Center, and German Center of Lung Research, Giessen, Germany (H.-A.G.); Department of Medicine, University of Alberta, Edmonton, AB, Canada (E.M.); Kerckhoff-Klinik Forschungsgesellschaft GmbH, Bad Nauheim, Germany (V.M.); Los Angeles Biomedical Research Institute at Harbor–UCLA Medical Center, Torrance, CA (R.J.O.); Bayer HealthCare Pharmaceuticals, New York, NY (F.B.); Bayer Hispania, Barcelona, Spain (A.-V.S.); Bayer Pharma AG, Berlin, Germany (L.R.); and Cardiology Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA (M.J.S.).
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Francis Boateng
From the Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria (D.B.); Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, University Hospital, Pavia, Italy (S.G.); Department of Cardiology and Internal Medicine B, University Medicine Greifswald, and DZHK (German Centre for Cardiovascular Research), Greifswald, Germany (S.B.F.); University of Giessen and Marburg Lung Center, and German Center of Lung Research, Giessen, Germany (H.-A.G.); Department of Medicine, University of Alberta, Edmonton, AB, Canada (E.M.); Kerckhoff-Klinik Forschungsgesellschaft GmbH, Bad Nauheim, Germany (V.M.); Los Angeles Biomedical Research Institute at Harbor–UCLA Medical Center, Torrance, CA (R.J.O.); Bayer HealthCare Pharmaceuticals, New York, NY (F.B.); Bayer Hispania, Barcelona, Spain (A.-V.S.); Bayer Pharma AG, Berlin, Germany (L.R.); and Cardiology Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA (M.J.S.).
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Andrea-Viviana Scalise
From the Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria (D.B.); Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, University Hospital, Pavia, Italy (S.G.); Department of Cardiology and Internal Medicine B, University Medicine Greifswald, and DZHK (German Centre for Cardiovascular Research), Greifswald, Germany (S.B.F.); University of Giessen and Marburg Lung Center, and German Center of Lung Research, Giessen, Germany (H.-A.G.); Department of Medicine, University of Alberta, Edmonton, AB, Canada (E.M.); Kerckhoff-Klinik Forschungsgesellschaft GmbH, Bad Nauheim, Germany (V.M.); Los Angeles Biomedical Research Institute at Harbor–UCLA Medical Center, Torrance, CA (R.J.O.); Bayer HealthCare Pharmaceuticals, New York, NY (F.B.); Bayer Hispania, Barcelona, Spain (A.-V.S.); Bayer Pharma AG, Berlin, Germany (L.R.); and Cardiology Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA (M.J.S.).
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Lothar Roessig
From the Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria (D.B.); Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, University Hospital, Pavia, Italy (S.G.); Department of Cardiology and Internal Medicine B, University Medicine Greifswald, and DZHK (German Centre for Cardiovascular Research), Greifswald, Germany (S.B.F.); University of Giessen and Marburg Lung Center, and German Center of Lung Research, Giessen, Germany (H.-A.G.); Department of Medicine, University of Alberta, Edmonton, AB, Canada (E.M.); Kerckhoff-Klinik Forschungsgesellschaft GmbH, Bad Nauheim, Germany (V.M.); Los Angeles Biomedical Research Institute at Harbor–UCLA Medical Center, Torrance, CA (R.J.O.); Bayer HealthCare Pharmaceuticals, New York, NY (F.B.); Bayer Hispania, Barcelona, Spain (A.-V.S.); Bayer Pharma AG, Berlin, Germany (L.R.); and Cardiology Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA (M.J.S.).
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Marc J. Semigran
From the Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria (D.B.); Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, University Hospital, Pavia, Italy (S.G.); Department of Cardiology and Internal Medicine B, University Medicine Greifswald, and DZHK (German Centre for Cardiovascular Research), Greifswald, Germany (S.B.F.); University of Giessen and Marburg Lung Center, and German Center of Lung Research, Giessen, Germany (H.-A.G.); Department of Medicine, University of Alberta, Edmonton, AB, Canada (E.M.); Kerckhoff-Klinik Forschungsgesellschaft GmbH, Bad Nauheim, Germany (V.M.); Los Angeles Biomedical Research Institute at Harbor–UCLA Medical Center, Torrance, CA (R.J.O.); Bayer HealthCare Pharmaceuticals, New York, NY (F.B.); Bayer Hispania, Barcelona, Spain (A.-V.S.); Bayer Pharma AG, Berlin, Germany (L.R.); and Cardiology Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA (M.J.S.).
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Abstract

Background—Pulmonary hypertension caused by systolic left ventricular dysfunction is associated with significant morbidity and mortality; however, no treatment is approved for this indication. We hypothesized that riociguat, a novel soluble guanylate cyclase stimulator, would have beneficial hemodynamic effects in patients with pulmonary hypertension caused by systolic left ventricular dysfunction.

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—Although the primary end point of the study was not met, riociguat was well tolerated in patients with pulmonary hypertension caused by systolic left ventricular dysfunction and improved cardiac index and pulmonary and systemic vascular resistance.

Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT01065454.

  • clinical trial
  • heart failure, systolic
  • hypertension, pulmonary
  • riociguat
  • soluble guanylate cyclase
  • Received September 20, 2012.
  • Accepted May 31, 2013.
  • © 2013 American Heart Association, Inc.

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July 30, 2013, Volume 128, Issue 5
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    Riociguat for Patients With Pulmonary Hypertension Caused by Systolic Left Ventricular DysfunctionClinical Perspective
    Diana Bonderman, Stefano Ghio, Stephan B. Felix, Hossein-Ardeschir Ghofrani, Evangelos Michelakis, Veselin Mitrovic, Ronald J. Oudiz, Francis Boateng, Andrea-Viviana Scalise, Lothar Roessig and Marc J. Semigran on behalf of the Left Ventricular Systolic Dysfunction Associated With Pulmonary Hypertension Riociguat Trial (LEPHT) Study Group
    Circulation. 2013;128:502-511, originally published July 29, 2013
    https://doi.org/10.1161/CIRCULATIONAHA.113.001458

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    Riociguat for Patients With Pulmonary Hypertension Caused by Systolic Left Ventricular DysfunctionClinical Perspective
    Diana Bonderman, Stefano Ghio, Stephan B. Felix, Hossein-Ardeschir Ghofrani, Evangelos Michelakis, Veselin Mitrovic, Ronald J. Oudiz, Francis Boateng, Andrea-Viviana Scalise, Lothar Roessig and Marc J. Semigran on behalf of the Left Ventricular Systolic Dysfunction Associated With Pulmonary Hypertension Riociguat Trial (LEPHT) Study Group
    Circulation. 2013;128:502-511, originally published July 29, 2013
    https://doi.org/10.1161/CIRCULATIONAHA.113.001458
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