Placebo Controlled, Randomized, Double-blind, Multi-center Study to Investigate the Efficacy and Tolerability of BAY58-2667

Congestive Heart Failure Clinical Trial

Official title:

Placebo Controlled, Randomized, Double-blind, Multi-center, Multinational Phase IIb Study to Investigate the Efficacy and Tolerability of BAY58-2667 Given Intravenously in Patients With Decompensated Chronic Congestive Heart Failure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00559650
• Other study ID #: 12480
• Secondary ID: 2007-003059-36
• Status: Terminated
• Phase: Phase 2
• First received: November 15, 2007
• Last updated: April 14, 2017
• Start date: December 2007
• Est. completion date: March 2009

Study information

• Verified date: April 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess a dose titration scheme, of a new drug (BAY58-2667) given intravenously, to evaluate if this is safe and can help to improve the well-being, symptoms (e.g. breathing) and outcome of decompensated heart failure. Patients living with chronic heart failure have a risk of increased number of hospitalisations because of worsening of their condition (decompensated heart failure). The current treatment of acute heart failure consists of oxygen and medical treatment with vasodilators and positive inotropic agents (drugs, which should strengthen the pump function of the heart) which have their limitations. Therefore there is a need for new drugs in treatment of acute heat failure.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with decompensated chronic congestive heart failure, NYHA functional class III-IV, either ischemic or non-ischemic, requiring hospitalization, and with clinical indication for parenteral pharmacotherapy and invasive hemodynamic monitoring (i.e indwelling Swan-Ganz pulmonary artery catheter) and PCWP >/= 18 mmHg.

• Patients must have the clinical diagnosis of CHF made at least 3 month prior to enrollment.

• Male or female patients, age 18 years or more.

Exclusion Criteria:

• Females of child-bearing potential.

• Acute de-novo heart failure.

• Acute myocardial infarction and/or myocardial infarction within 30 days.

• Valvular heart disease requiring surgical intervention during the course of the study.

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Drug:
• Placebo
Will be standard therapy and placebo versus, Uptitration from 100-600µg/g, intravenous, over maximum 48 hours
• Cinaciguat (BAY58-2667)
Will be standard therapy and BAY 58-2667, Uptitration from 100-600µg/g, intravenous, over maximum 48 hours

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Canada,  Croatia,  Czech Republic,  Estonia,  Germany,  Hungary,  Israel,  Italy,  Lithuania,  Poland,  Russian Federation,  Serbia,  Slovenia,  Spain,  Sweden,  United Kingdom, 

References & Publications (1)

Erdmann E, Semigran MJ, Nieminen MS, Gheorghiade M, Agrawal R, Mitrovic V, Mebazaa A. Cinaciguat, a soluble guanylate cyclase activator, unloads the heart but also causes hypotension in acute decompensated heart failure. Eur Heart J. 2013 Jan;34(1):57-67. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy outcome measure will be the change of pulmonary capillary wedge pressure (PCWP) from baseline to 8 hours versus placebo.		8 hours
Secondary	Quality of Life		Up to 30 days Follow-up
Secondary	Rehospitalization		Up to 30 days Follow-up
Secondary	Other hemodynamic measurements	Right atrial pressure (RAP); mean pulmonary artery pressure (PAP mean); pulmonary artery systolic pressure (PASP); pulmonary artery diastolic pressure (PADP); cardiac output (CO); cardiac index (CI); mean arterial pressure (MAP); pulmonary vascular resistance (PVR); pulmonary vascular resistance index (PVRI); systemic vascular resistance (SVR); and systemic vascular resistance index (SVRI)	Up to 48 hours
Secondary	Safety variables	Treatment-emergent adverse events, laboratory parameters, renal function, in-hospital mortality, length of stay at intensive care unit, and 30-day mortality / morbidity.	Up to 30 days follow up
Secondary	Plasma concentrations		During both the titration and maintenance phases were evaluated.

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