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

NCT00559650 | Terminated Phase 2 DMC

• 2 other identifiers: 124802007-003059-36
• Study Type: interventional
• Target: 150
• Locations: 15 countries
• Sites: 68

Brief 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.

Conditions

Congestive Heart Failure

Keywords

Acute decompensated heart failure; Double blind study,; BAY58-2667; Soluble guanylate cyclase activator

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Quality of Life

  Up to 30 days Follow-up

• Rehospitalization

  Up to 30 days Follow-up

• Other hemodynamic measurements

  Up to 48 hours

• Safety variables

  Up to 30 days follow up

• Plasma concentrations

  During both the titration and maintenance phases were evaluated.

Study Arms (2)

Arm 1

PLACEBO COMPARATOR

Drug: Placebo

Arm 2

EXPERIMENTAL

Drug: Cinaciguat (BAY58-2667)

Interventions

Placebo DRUG

Will be standard therapy and placebo versus, Uptitration from 100-600µg/g, intravenous, over maximum 48 hours

Arm 1

Cinaciguat (BAY58-2667) DRUG

Will be standard therapy and BAY 58-2667, Uptitration from 100-600µg/g, intravenous, over maximum 48 hours

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (72)

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San Diego, California, 92103-8765, United States

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Washington D.C., District of Columbia, 20010, United States

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Boston, Massachusetts, 02114, United States

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Cincinnati, Ohio, 45219-2316, United States

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Fairfield, Ohio, 45014, United States

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Dallas, Texas, 75216-7167, United States

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Halifax, Nova Scotia, B3H 3A7, Canada

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Toronto, Ontario, M5B 1W8, Canada

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Ste-Foy, Quebec, G1V 4G5, Canada

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Split, 21000, Croatia

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Zagreb, 10000, Croatia

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Brno, 625 00, Czechia

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Brno, 656 91, Czechia

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Hradec Králové, 500 05, Czechia

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Pilsen, 301 00, Czechia

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Prague, 128 08, Czechia

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Prague, 12808, Czechia

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Tallinn, 13419, Estonia

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Tartu, 51014, Estonia

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Heidelberg, Baden-Wurttemberg, 69120, Germany

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Würzburg, Bavaria, 97080, Germany

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Bad Nauheim, Hesse, 61231, Germany

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Greifswald, Mecklenburg-Vorpommern, 17475, Germany

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Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

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Bonn, North Rhine-Westphalia, 53105, Germany

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Cologne, North Rhine-Westphalia, 50924, Germany

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Homburg, Saarland, 66424, Germany

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Halle, Saxony-Anhalt, 06120, Germany

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Berlin, State of Berlin, 12200, Germany

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Erfurt, Thuringia, 99089, Germany

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Jena, Thuringia, 07740, Germany

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Budapest, H-1096, Hungary

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Debrecen, 4032, Hungary

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Vác, 2600, Hungary

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Zalaegerszeg, 8900, Hungary

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Haifa, Israel, 34362, Israel

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Jerusalem, 9112001, Israel

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Ramat Gan, 5262000, Israel

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Safed, 1311001, Israel

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Bologna, Emilia-Romagna, 40138, Italy

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Ferrara, Emilia-Romagna, 44100, Italy

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Milan, Lombardy, 20162, Italy

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Pavia, Lombardy, 27100, Italy

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Perugia, Umbria, 06156, Italy

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Bergamo, 24128, Italy

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Kaunas, 50009, Lithuania

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Vilnius, 08661, Lithuania

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Gdansk, 80-211, Poland

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Krakow, 31-202, Poland

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Szczecin, 70-111, Poland

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Wroclaw, 50-981, Poland

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Zabrze, 41-800, Poland

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Moscow, 109263, Russia

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Moscow, 115093, Russia

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Moscow, 119435, Russia

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Moscow, 129010, Russia

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Belgrade, 11000, Serbia

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Kamenitz, 21204, Serbia

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Celje, 3000, Slovenia

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Golnik, 4204, Slovenia

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Ljubljana, 1000, Slovenia

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Murska Sobota, 9000, Slovenia

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Santiago de Compostela, A Coruña, 15706, Spain

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Barcelona, Barcelona, 08036, Spain

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Sabadell, Barcelona, 08208, Spain

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Girona, Girona, 17007, Spain

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Majadahonda, Madrid, 28222, Spain

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Gothenburg, 413 45, Sweden

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Uppsala, 751 85, Sweden

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Chesterfield, Derbyshire, S44 5BL, United Kingdom

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Barnet, Hertfordshire, EN5 3DJ, United Kingdom

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Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

Related 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. doi: 10.1093/eurheartj/ehs196. Epub 2012 Jul 9.

  PMID: 22778174 RESULT

Related Links

• Click here and search for Bayer product information provided by EMA

MeSH Terms

Conditions

Heart Failure

Interventions

BAY 58-2667

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2007
• First Posted: November 16, 2007
• Study Start: December 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: March 1, 2009
• Last Updated: April 18, 2017

Record last verified: 2017-04

Locations

GB (3); CA (3); IT (6); SE (2); RU (4); IL (4); SL (4); LI (2); US (6); ES (5); DE (12); HU (4); CR (2); CZ (6); PL (5)