A Phase IIb Study to Investigate the Efficacy and Tolerability of Cinaciguat (150 µg/h, 100 µg/h, 50 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF)

NCT01064037 | Terminated Phase 2 DMC

• 2 other identifiers: 148362009-017082-39
• Study Type: interventional
• Target: 62
• Locations: 16 countries
• Sites: 70

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

Heart Failure; Heart Decompensation

Keywords

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Dyspnea VAS (using a visual analogue scale)

  8 hours

Secondary Outcomes (8)

• Dyspnea assessment (Likert Scale)

  up to follow-up (30 - 35 days)

• Overall health status assessment (EQ-5D)

  up to follow-up (30 - 35 days)

• Changes in the dyspnea VAS at other time points

  Up to follow up visit

• Dyspnea assessment through Likert scale

  Up to follow up visit

• Overall health status assessment through EQ-5D Health Questionnaire

  Up to the follow-up visit

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 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 ovarectomy, and women with a hysterectomy
• Subjects must have the clinical diagnosis of congestive heart failure (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 (70)

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Chicago, Illinois, 60610, United States

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Detroit, Michigan, 48201, United States

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Cincinnati, Ohio, 45267, United States

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Cleveland, Ohio, 44195, United States

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Nashville, Tennessee, 37232-7240, United States

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Houston, Texas, 77030, United States

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Calgary, Alberta, T2N 4Z6, Canada

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Vancouver, British Columbia, V5Z 1M9, Canada

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Québec, Quebec, G1V 4G5, Canada

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Brno, 625 00, Czechia

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Pardubice, 532 03, Czechia

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Prague, 10034, Czechia

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Prague, 15006, Czechia

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Prague, 15030, Czechia

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Jyväskylä, Jyväskylä, Finland

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Turku, Turku, Finland

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Dommartin-lès-Toul, 54201, France

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Paris, 75013, France

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Paris, 75181, France

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Paris, 75475, France

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Poitiers, 86021, France

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Nuremberg, Bavaria, 90471, Germany

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Melsungen, Hesse, 34212, Germany

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Mönchengladbach, North Rhine-Westphalia, 41063, Germany

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Kiel, Schleswig-Holstein, 24105, Germany

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Berlin, State of Berlin, 12200, Germany

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Erfurt, Thuringia, 99089, Germany

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Budapest, 1027, Hungary

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Budapest, 1096, Hungary

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Budapest, H-1096, Hungary

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Kecskemét, 6000, Hungary

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Székesfehérvár, 8000, Hungary

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Ballinasloe, Co. Galway, Ireland

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Dublin, Dublin, 8, Ireland

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Dublin, DUBLIN 4, Ireland

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Haifa, Israel, 31096, Israel

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Rehovot, Israel, 76100, Israel

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Safed, Israel, 13100, Israel

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Nahariya, Israel

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Pontedecimo, Genova, 16164, Italy

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Casarano, Lecce, 73042, Italy

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Cotignola, Ravenna, 48010, Italy

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Bari, 70124, Italy

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Ferrara, 44100, Italy

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Padua, 35128, Italy

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Roma, 00161, Italy

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Roma, 00192, Italy

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Kanazawa, Ishikawa-ken, 920-8650, Japan

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Kagoshima, Kagoshima-ken, 892-0853, Japan

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Chigasaki, Kanagawa, 253-8558, Japan

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Matsumoto, Nagano, 399-8701, Japan

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Shizuoka, Shizuoka, 421-0193, Japan

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Sunto, Shizuoka, 411-8611, Japan

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Tanabe, Wakayama, 646-8558, Japan

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Bydgoszcz, 85-681, Poland

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Krakow, 31-121, Poland

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Olsztyn, 10-228, Poland

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Szczecin, 70-965, Poland

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Johannesburg, Gauteng, 1449, South Africa

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Johannesburg, Gauteng, 2194, South Africa

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Kuils River, Western Cape, 7580, South Africa

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Worcester, Western Cape, 6850, South Africa

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Seoul, Jongno-gu,, 110-744, South Korea

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Seoul, Songpa-gu, 138-736, South Korea

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Torrevieja, Alicante, 03186, Spain

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Barcelona, Barcelona, 08035, Spain

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Majadahonda, Madrid, 28222, Spain

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El Palmar, Murcia, 30120, Spain

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Harrow, London, HA1 3UJ, United Kingdom

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Northampton, Northamptonshire, NN1 5BD, United Kingdom

Location

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 4, 2010
• First Posted: February 8, 2010
• Study Start: April 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: October 8, 2015

Record last verified: 2014-10

Locations

CA (3); CZ (5); FI (2); ES (4); JP (7); ZA (4); KR (2); IL (4); IE (3); HU (5); FR (5); DE (6); US (6); IT (8); PL (4); GB (2)