Left ventricular systolic dysfunction associated with pulmonary hypertension riociguat trial (LEPHT): Rationale and design

Stefano Ghio; Diana Bonderman; Stephan B. Felix; Hossein A. Ghofrani; Evangelos D. Michelakis; Veselin Mitrovic; Ronald J. Oudiz; Reiner Frey; Lothar Roessig; Marc J. Semigran

doi:10.1093/eurjhf/hfs071

Left ventricular systolic dysfunction associated with pulmonary hypertension riociguat trial (LEPHT): Rationale and design

Stefano Ghio, Diana Bonderman, Stephan B. Felix, Hossein A. Ghofrani, Evangelos D. Michelakis, Veselin Mitrovic, Ronald J. Oudiz, Reiner Frey, Lothar Roessig, Marc J. Semigran

IRCCS Fondazione Policlinico San Matteo

Research output: Contribution to journal › Article › peer-review

Abstract

Aims Pulmonary hypertension (PH) due to systolic left ventricular dysfunction (PH-sLVD) frequently complicates heart failure (HF), and greatly worsens the prognosis of patients with sLVD, but as yet has no approved treatment. The LEPHT study Aims to characterize the haemodynamic profile, safety, tolerability, and pharmacokinetic profile of riociguat (BAY 63-2521), an oral stimulator of soluble guanylate cyclase, in patients with PH-sLVD.Methods and resultsThis 16-week, phase IIb, randomized, placebo-controlled, double-blind study enrols patients with PH-sLVD, defined as left ventricular ejection fraction (LVEF) ≤40 and mean pulmonary arterial pressure (PAPmean)

Original language	English
Pages (from-to)	946-953
Number of pages	8
Journal	European Journal of Heart Failure
Volume	14
Issue number	8
DOIs	https://doi.org/10.1093/eurjhf/hfs071
Publication status	Published - Aug 2012

Keywords

Clinical trial
Pulmonary hypertension
Riociguat
Soluble guanylate cyclase stimulator
Systolic heart failure

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1093/eurjhf/hfs071

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title = "Left ventricular systolic dysfunction associated with pulmonary hypertension riociguat trial (LEPHT): Rationale and design",

abstract = "Aims Pulmonary hypertension (PH) due to systolic left ventricular dysfunction (PH-sLVD) frequently complicates heart failure (HF), and greatly worsens the prognosis of patients with sLVD, but as yet has no approved treatment. The LEPHT study Aims to characterize the haemodynamic profile, safety, tolerability, and pharmacokinetic profile of riociguat (BAY 63-2521), an oral stimulator of soluble guanylate cyclase, in patients with PH-sLVD.Methods and resultsThis 16-week, phase IIb, randomized, placebo-controlled, double-blind study enrols patients with PH-sLVD, defined as left ventricular ejection fraction (LVEF) ≤40 and mean pulmonary arterial pressure (PAPmean) ",

keywords = "Clinical trial, Pulmonary hypertension, Riociguat, Soluble guanylate cyclase stimulator, Systolic heart failure",

author = "Stefano Ghio and Diana Bonderman and Felix, {Stephan B.} and Ghofrani, {Hossein A.} and Michelakis, {Evangelos D.} and Veselin Mitrovic and Oudiz, {Ronald J.} and Reiner Frey and Lothar Roessig and Semigran, {Marc J.}",

year = "2012",

month = aug,

doi = "10.1093/eurjhf/hfs071",

language = "English",

volume = "14",

pages = "946--953",

journal = "European Journal of Heart Failure",

issn = "1388-9842",

publisher = "John Wiley & Sons, Ltd",

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TY - JOUR

T1 - Left ventricular systolic dysfunction associated with pulmonary hypertension riociguat trial (LEPHT)

T2 - Rationale and design

AU - Ghio, Stefano

AU - Bonderman, Diana

AU - Felix, Stephan B.

AU - Ghofrani, Hossein A.

AU - Michelakis, Evangelos D.

AU - Mitrovic, Veselin

AU - Oudiz, Ronald J.

AU - Frey, Reiner

AU - Roessig, Lothar

AU - Semigran, Marc J.

PY - 2012/8

Y1 - 2012/8

N2 - Aims Pulmonary hypertension (PH) due to systolic left ventricular dysfunction (PH-sLVD) frequently complicates heart failure (HF), and greatly worsens the prognosis of patients with sLVD, but as yet has no approved treatment. The LEPHT study Aims to characterize the haemodynamic profile, safety, tolerability, and pharmacokinetic profile of riociguat (BAY 63-2521), an oral stimulator of soluble guanylate cyclase, in patients with PH-sLVD.Methods and resultsThis 16-week, phase IIb, randomized, placebo-controlled, double-blind study enrols patients with PH-sLVD, defined as left ventricular ejection fraction (LVEF) ≤40 and mean pulmonary arterial pressure (PAPmean)

AB - Aims Pulmonary hypertension (PH) due to systolic left ventricular dysfunction (PH-sLVD) frequently complicates heart failure (HF), and greatly worsens the prognosis of patients with sLVD, but as yet has no approved treatment. The LEPHT study Aims to characterize the haemodynamic profile, safety, tolerability, and pharmacokinetic profile of riociguat (BAY 63-2521), an oral stimulator of soluble guanylate cyclase, in patients with PH-sLVD.Methods and resultsThis 16-week, phase IIb, randomized, placebo-controlled, double-blind study enrols patients with PH-sLVD, defined as left ventricular ejection fraction (LVEF) ≤40 and mean pulmonary arterial pressure (PAPmean)

KW - Clinical trial

KW - Pulmonary hypertension

KW - Riociguat

KW - Soluble guanylate cyclase stimulator

KW - Systolic heart failure

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JO - European Journal of Heart Failure

JF - European Journal of Heart Failure

SN - 1388-9842

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ER -

Left ventricular systolic dysfunction associated with pulmonary hypertension riociguat trial (LEPHT): Rationale and design

Abstract

Keywords

ASJC Scopus subject areas

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