Heart FailurePhase 2COMPOSE EARLYNCT01064037
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)
A Phase 2 study testing Cinaciguat (BAY58-2667) in people with Heart Failure and Heart Decompensation, run by Bayer at 70 sites in 16 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Decompensation
- 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
- 62 participants
- Where
- 70 sitesin 16 countries
- Study dates
- Apr 2010to Mar 2011
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
70 sites in 16 countries.
70 sites in 16 countries
Italy8 sites
Study site
Bari, 70124
Study site
Casarano, Lecce, 73042
Study site
Cotignola, Ravenna, 48010
Study site
Ferrara, 44100
Study site
Padova, 35128
Study site
Pontedecimo, Genova, 16164
Study site
Roma, 00161
Study site
Roma, 00192
Japan7 sites
Study site
Chigasaki, Kanagawa, 253-8558
Study site
Kagoshima, Kagoshima-ken, 892-0853
Study site
Kanazawa, Ishikawa-ken, 920-8650
Study site
Matsumoto, Nagano, 399-8701
Study site
Shizuoka, Shizuoka, 421-0193
Study site
Sunto, Shizuoka, 411-8611
Study site
Tanabe, Wakayama, 646-8558
United States6 sites
Study site
Chicago, Illinois, 60610
Study site
Cincinnati, Ohio, 45267
Study site
Cleveland, Ohio, 44195
Study site
Detroit, Michigan, 48201
Study site
Houston, Texas, 77030
Study site
Nashville, Tennessee, 37232-7240
Germany6 sites
Study site
Berlin, State of Berlin, 12200
Study site
Erfurt, Thuringia, 99089
Study site
Kiel, Schleswig-Holstein, 24105
Study site
Melsungen, Hesse, 34212
Study site
Mönchengladbach, North Rhine-Westphalia, 41063
Study site
Nuremberg, Bavaria, 90471
Czechia5 sites
Study site
Brno, 625 00
Study site
Pardubice, 532 03
Study site
Prague, 10034
Study site
Prague, 15006
Study site
Prague, 15030
France5 sites
Study site
Dommartin-lès-Toul, 54201
Study site
Paris, 75013
Study site
Paris, 75181
Study site
Paris, 75475
Study site
Poitiers, 86021
Hungary5 sites
Study site
Budapest, 1027
Study site
Budapest, 1096
Study site
Budapest, H-1096
Study site
Kecskemét, 6000
Study site
Székesfehérvár, 8000
Israel4 sites
Study site
Haifa, Israel, 31096
Study site
Nahariya
Study site
Rehovot, Israel, 76100
Study site
Safed, Israel, 13100
Poland4 sites
Study site
Bydgoszcz, 85-681
Study site
Krakow, 31-121
Study site
Olsztyn, 10-228
Study site
Szczecin, 70-965
South Africa4 sites
Study site
Johannesburg, Gauteng, 1449
Study site
Johannesburg, Gauteng, 2194
Study site
Kuils River, Western Cape, 7580
Study site
Worcester, Western Cape, 6850
Spain4 sites
Study site
Barcelona, Barcelona, 08035
Study site
El Palmar, Murcia, 30120
Study site
Majadahonda, Madrid, 28222
Study site
Torrevieja, Alicante, 03186
Canada3 sites
Study site
Calgary, Alberta, T2N 4Z6
Study site
Québec, Quebec, G1V 4G5
Study site
Vancouver, British Columbia, V5Z 1M9
Ireland3 sites
Study site
Ballinasloe, Co. Galway
Study site
Dublin, Dublin, 8
Study site
Dublin, DUBLIN 4
South Korea2 sites
Study site
Seoul, Jongno-gu,, 110-744
Study site
Seoul, Songpa-gu, 138-736
United Kingdom2 sites
Study site
Harrow, London, HA1 3UJ
Study site
Northampton, Northamptonshire, NN1 5BD
About this study
Official title: A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of BAY 58-2667 (50 µg/h, 100 µg/h, 150 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF) Within 12 Hours After Hospital Admission (Pulmonary Artery Catheter eg, Swan-Ganz Not Required)
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
- Being tested
- Cinaciguat (BAY58-2667), Placebo
- Keywords
- Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cinaciguat (BAY58-2667)Drug
Infusion of 150 µg/h during 48h.
Cinaciguat (BAY58-2667)Drug
Infusion of 100 µg/h during 48h
Cinaciguat (BAY58-2667)Drug
Infusion of 50 µg/h during 48h
PlaceboDrug
Infusion during 48h
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Cinaciguat (BAY58-2667) |
| Arm 2 | Experimental | Not described Receives: Drug: Cinaciguat (BAY58-2667) |
| Arm 3 | Experimental | Not described Receives: Drug: Cinaciguat (BAY58-2667) |
| Arm 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea VAS (using a visual analogue scale)
Measured: 8 hours
Secondary outcomes (8)
Dyspnea assessment (Likert Scale)
Measured: up to follow-up (30 - 35 days)
Overall health status assessment (EQ-5D)
Measured: up to follow-up (30 - 35 days)
Changes in the dyspnea VAS at other time points
Measured: Up to follow up visit
Dyspnea assessment through Likert scale
Measured: Up to follow up visit
Overall health status assessment through EQ-5D Health Questionnaire
Measured: Up to the follow-up visit
Global clinical assessment by the physician
Measured: At 8, 24, and 48 hours
Change in concomitant medications
Measured: During the treatment
Safety variables
Frequency of TEAEs (AEs were considered to be treatment emergent if they started after the start of sthe study drug infusion to up to 2 calendar days after the end of the study drug infusion); treatment-emergent serious adverse events (SAEs); deaths; evaluation of renal and cardiac function; Change in heart rate; Change in systolic and diastolic blood pressure; Laboratory parameters (including parameters related to hematology, clinical chemistry, urinalysis, and biomarkers); ECG assessment
Measured: Up to end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study startApr 2010
- Primary completionFeb 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064037
- Sponsor's protocol ID
- 14836
- Other IDs
- 2009-017082-39, 2009
- Acronym
- COMPOSE EARLY
- Status last verified
- Oct 2014
- First submitted
- 4 Feb 2010
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of BAY 58-2667 (50 µg/h, 100 µg/h, 150 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF) Within 12 Hours After Hospital Admission (Pulmonary Artery Catheter eg, Swan-Ganz Not Required)
- ClinicalTrials.gov ID
- NCT01064037
- Acronym / sponsor ID
- COMPOSE EARLY / 14836
- Conditions
- Heart Failure, Heart Decompensation
- Keywords
- Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 62 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 8 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cinaciguat (BAY58-2667)Infusion of 150 µg/h during 48h. | Drug | Arm 1 |
| Cinaciguat (BAY58-2667)Infusion of 100 µg/h during 48h | Drug | Arm 2 |
| Cinaciguat (BAY58-2667)Infusion of 50 µg/h during 48h | Drug | Arm 3 |
| PlaceboInfusion during 48h | Drug | Arm 4 |
Primary outcome
Dyspnea VAS (using a visual analogue scale)
Time frame: 8 hours
8 secondary outcomes
Dyspnea assessment (Likert Scale)
Time frame: up to follow-up (30 - 35 days)
Overall health status assessment (EQ-5D)
Time frame: up to follow-up (30 - 35 days)
Changes in the dyspnea VAS at other time points
Time frame: Up to follow up visit
Dyspnea assessment through Likert scale
Time frame: Up to follow up visit
Overall health status assessment through EQ-5D Health Questionnaire
Time frame: Up to the follow-up visit
Global clinical assessment by the physician
Time frame: At 8, 24, and 48 hours
Change in concomitant medications
Time frame: During the treatment
Safety variables
Time frame: Up to end of study
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
70 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cinaciguat (BAY58-2667) in people with Heart Failure and Heart Decompensation, run by Bayer at 70 sites in 16 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 7 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 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in Italy, Japan, United States, Germany, Czechia and 11 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?
Dyspnea VAS (using a visual analogue scale) (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2015.