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Congestive Heart FailurePhase 2NCT00559650

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

A Phase 2 study testing Cinaciguat (BAY58-2667) in people with Congestive Heart Failure, run by Bayer at 72 sites in 17 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Congestive Heart Failure
What is being tested?
Cinaciguat (BAY58-2667)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
72 sitesin 17 countries
Study dates
Dec 2007to Mar 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

72 sites in 17 countries.

72 sites in 17 countries

Germany12 sites

  • Study site

    Bad Nauheim, Hesse, 61231

  • Study site

    Bad Oeynhausen, North Rhine-Westphalia, 32545

  • Study site

    Berlin, State of Berlin, 12200

  • Study site

    Bonn, North Rhine-Westphalia, 53105

  • Study site

    Cologne, North Rhine-Westphalia, 50924

  • Study site

    Erfurt, Thuringia, 99089

  • Study site

    Greifswald, Mecklenburg-Vorpommern, 17475

  • Study site

    Halle, Saxony-Anhalt, 06120

  • Study site

    Heidelberg, Baden-Wurttemberg, 69120

  • Study site

    Homburg, Saarland, 66424

  • Study site

    Jena, Thuringia, 07740

  • Study site

    Würzburg, Bavaria, 97080

Other trials in Germany

United States6 sites

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Cincinnati, Ohio, 45219-2316

  • Study site

    Dallas, Texas, 75216-7167

  • Study site

    Fairfield, Ohio, 45014

  • Study site

    San Diego, California, 92103-8765

  • Study site

    Washington D.C., District of Columbia, 20010

Other trials in United States

Czechia6 sites

  • Study site

    Brno, 625 00

  • Study site

    Brno, 656 91

  • Study site

    Hradec Králové, 500 05

  • Study site

    Pilsen, 301 00

  • Study site

    Prague, 128 08

  • Study site

    Prague, 12808

Other trials in Czechia

Italy6 sites

  • Study site

    Bergamo, 24128

  • Study site

    Bologna, Emilia-Romagna, 40138

  • Study site

    Ferrara, Emilia-Romagna, 44100

  • Study site

    Milan, Lombardy, 20162

  • Study site

    Pavia, Lombardy, 27100

  • Study site

    Perugia, Umbria, 06156

Other trials in Italy

Poland5 sites

  • Study site

    Gdansk, 80-211

  • Study site

    Krakow, 31-202

  • Study site

    Szczecin, 70-111

  • Study site

    Wroclaw, 50-981

  • Study site

    Zabrze, 41-800

Other trials in Poland

Spain5 sites

  • Study site

    Barcelona, Barcelona, 08036

  • Study site

    Girona, Girona, 17007

  • Study site

    Majadahonda, Madrid, 28222

  • Study site

    Sabadell, Barcelona, 08208

  • Study site

    Santiago de Compostela, A Coruña, 15706

Other trials in Spain

Hungary4 sites

  • Study site

    Budapest, H-1096

  • Study site

    Debrecen, 4032

  • Study site

    Vác, 2600

  • Study site

    Zalaegerszeg, 8900

Other trials in Hungary

Israel4 sites

  • Study site

    Haifa, Israel, 34362

  • Study site

    Jerusalem, 9112001

  • Study site

    Ramat Gan, 5262000

  • Study site

    Safed, 1311001

Other trials in Israel

Russia4 sites

  • Study site

    Moscow, 109263

  • Study site

    Moscow, 115093

  • Study site

    Moscow, 119435

  • Study site

    Moscow, 129010

Other trials in Russia

Slovenia4 sites

  • Study site

    Celje, 3000

  • Study site

    Golnik, 4204

  • Study site

    Ljubljana, 1000

  • Study site

    Murska Sobota, 9000

Other trials in Slovenia

Canada3 sites

  • Study site

    Halifax, Nova Scotia, B3H 3A7

  • Study site

    Ste-Foy, Quebec, G1V 4G5

  • Study site

    Toronto, Ontario, M5B 1W8

Other trials in Canada

United Kingdom3 sites

  • Study site

    Barnet, Hertfordshire, EN5 3DJ

  • Study site

    Chesterfield, Derbyshire, S44 5BL

  • Study site

    Harrow, Middlesex, HA1 3UJ

Other trials in United Kingdom

Croatia2 sites

  • Study site

    Split, 21000

  • Study site

    Zagreb, 10000

Other trials in Croatia

Estonia2 sites

  • Study site

    Tallinn, 13419

  • Study site

    Tartu, 51014

Other trials in Estonia

Lithuania2 sites

  • Study site

    Kaunas, 50009

  • Study site

    Vilnius, 08661

Other trials in Lithuania

Serbia2 sites

  • Study site

    Belgrade, 11000

  • Study site

    Kamenitz, 21204

Other trials in Serbia

Sweden2 sites

  • Study site

    Gothenburg, 413 45

  • Study site

    Uppsala, 751 85

Other trials in Sweden

About this study

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

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.

Being tested
Placebo, Cinaciguat (BAY58-2667)
Keywords
Acute decompensated heart failure, Double blind study,, BAY58-2667, Soluble guanylate cyclase activator
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

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

  • Cinaciguat (BAY58-2667)Drug

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

Study groups in NCT00559650
Study groupRoleWhat they receive
Arm 1Placebo comparatorNot described
Receives: Drug: Placebo
Arm 2ExperimentalNot described
Receives: Drug: Cinaciguat (BAY58-2667)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary efficacy outcome measure will be the change of pulmonary capillary wedge pressure (PCWP) from baseline to 8 hours versus placebo.

    Measured: 8 hours

Secondary outcomes (5)

  1. Quality of Life

    Measured: Up to 30 days Follow-up

  2. Rehospitalization

    Measured: Up to 30 days Follow-up

  3. 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）

    Measured: Up to 48 hours

  4. 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.

    Measured: Up to 30 days follow up

  5. Plasma concentrations

    Measured: During both the titration and maintenance phases were evaluated.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionFeb 2009
  4. Study completionMar 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00559650
Sponsor's protocol ID
12480
Other IDs
2007-003059-36
Status last verified
Apr 2017
First submitted
15 Nov 2007
Last updated
18 Apr 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22778174

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cinaciguat (BAY58-2667) in people with Congestive Heart Failure, run by Bayer at 72 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in Germany, United States, Czechia, Italy, Poland and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary efficacy outcome measure will be the change of pulmonary capillary wedge pressure (PCWP) from baseline to 8 hours versus placebo. (time frame: 8 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00559650, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017.

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