BAY58-2667 Dose Finding Trial Investigating Fixed Doses in Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF)

NCT01065077 | Terminated Phase 2 DMC

• 2 other identifiers: 145602009-014377-40
• Study Type: interventional
• Target: 12
• Locations: 15 countries
• Sites: 54

Brief Summary

A placebo controlled, double-blind and randomized study to assess different doses of a new drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of patients with acute decompensated heart failure.

Conditions

Acute Heart Failure

Keywords

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Pulmonary Capillary Wedge Pressure

  8 hours

Secondary Outcomes (3)

• Cardiac index (CI)

  8 hours and 48 hours

• Kansas City Cardiomyopathy Questionnaire (KCCQ)

  Follow up (30 + 5 days)

• Right atrial pressure (RAP)

  8 hours and 48 hours

Study Arms (4)

Arm 1

EXPERIMENTAL

Drug: Cinaciguat (BAY58-2667)

Arm 2

EXPERIMENTAL

Drug: Cinaciguat (BAY58-2667)

Arm 3

EXPERIMENTAL

Drug: Cinaciguat (BAY58-2667)

Arm 4

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Cinaciguat (BAY58-2667) DRUG

Infusion of 150 µg/h during 48h

Arm 1

Placebo DRUG

Infusion of placebo during 48h

Arm 4

Eligibility Criteria

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

You may qualify if:

• Male and non-pregnant, non-lactating female subjects, age \>/= 18 years of age; or women without childbearing potential defined as postmenopausal women aged 55 years or older, women with bilateral tubal ligation, women with bilateral ovariectomy, and women with a hysterectomy
• Subjects must have the clinical diagnosis of CHF made at least three months prior to enrollment
• Subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study:
• dyspnea and
• clinical evidence of volume overload

You may not qualify if:

• 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
• Heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease
• Primary hypertrophic cardiomyopathy
• Acute inflammatory heart disease, eg, acute myocarditis
• Unstable angina requiring angiography

Sponsors & Collaborators

• Bayer: lead

Study Sites (59)

Unknown Facility

Ridgewood, New Jersey, 07450, United States

Location

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Winston-Salem, North Carolina, 27157, United States

Location

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Cleveland, Ohio, 44106, United States

Location

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Fairfield, Ohio, 45014, United States

Location

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Philadelphia, Pennsylvania, 19102, United States

Location

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Philadelphia, Pennsylvania, 19107, United States

Location

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Linz, Upper Austria, 4010, Austria

Location

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Vienna, Vienna, 1090, Austria

Location

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Zagreb, 10000, Croatia

Location

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Helsinki, 00029, Finland

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Oulu, 90220, Finland

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Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

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Cologne, North Rhine-Westphalia, 50924, Germany

Location

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Homburg, Saarland, 66424, Germany

Location

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Erfurt, Thuringia, 99089, Germany

Location

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Jena, Thuringia, 07740, Germany

Location

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Haifa, Israel, 34362, Israel

Location

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Jerusalem, Israel, 91120, Israel

Location

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Tiberias, Israel, 31905, Israel

Location

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San Fermo della Battaglia, Como, 22020, Italy

Location

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Brescia, 25100, Italy

Location

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Ferrara, 44100, Italy

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Mantova, 46100, Italy

Location

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Torino, 10126, Italy

Location

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Nagoya, Aichi-ken, 460-0001, Japan

Location

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Kure, Hiroshima, 737-0023, Japan

Location

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Higashiibaraki, Ibaraki, 311-3193, Japan

Location

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Kawasaki, Kanagawa, 216-8511, Japan

Location

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Ōmura, Nagasaki, 856-8562, Japan

Location

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Osaka, Osaka, 543-0035, Japan

Location

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Bunkyo-ku, Tokyo, 113-8603, Japan

Location

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Shinagawa, Tokyo, 142-8666, Japan

Location

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Gdansk, 80-211, Poland

Location

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Lodz, 91-347, Poland

Location

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Warsaw, 02-507, Poland

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Warsaw, 04-628, Poland

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Wroclaw, 50-981, Poland

Location

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Zabrze, 41-800, Poland

Location

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Zgorzelec, 59-900, Poland

Location

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Bucharest, 022328, Romania

Location

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Cluj-Napoca, 400001, Romania

Location

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Krasnoyarsk, 660022, Russia

Location

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Moscow, 109263, Russia

Location

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Moscow, 115093, Russia

Location

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Moscow, 119881, Russia

Location

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Belgrade, 11000, Serbia

Location

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Kamenitz, 21204, Serbia

Location

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Niš, 18000, Serbia

Location

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Lučenec, 984 39, Slovakia

Location

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Martin, 036 59, Slovakia

Location

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Celje, 3000, Slovenia

Location

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Golnik, 4204, Slovenia

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Ljubljana, 1000, Slovenia

Location

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Gothenburg, 413 45, Sweden

Location

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Uppsala, 751 85, Sweden

Location

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Zurich, Canton of Zurich, 8091, Switzerland

Location

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Lugano, Canton Ticino, 6900, Switzerland

Location

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Bangkok, Thailand, 10400, Thailand

Location

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Bangkok, 10400, Thailand

Location

Related Publications (1)

• Gheorghiade M, Greene SJ, Filippatos G, Erdmann E, Ferrari R, Levy PD, Maggioni A, Nowack C, Mebazaa A; COMPOSE Investigators and Coordinators. Cinaciguat, a soluble guanylate cyclase activator: results from the randomized, controlled, phase IIb COMPOSE programme in acute heart failure syndromes. Eur J Heart Fail. 2012 Sep;14(9):1056-66. doi: 10.1093/eurjhf/hfs093. Epub 2012 Jun 19.

  PMID: 22713287 RESULT

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

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: February 8, 2010
• First Posted: February 9, 2010
• Study Start: March 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2011
• Last Updated: October 8, 2015

Record last verified: 2014-11

Locations

US (6); SL (3); SE (2); DE (5); CH (2); IT (5); PL (7); AU (2); IL (3); FI (2); TH (2); CR (1); RO (2); RU (4); JP (8)