Heart FailurePhase 2CHIARA MIA 1NCT02452515
A Single-blind Pilot Study to Investigate Safety and Tolerability of the Chymase Inhibitor BAY1142524 in Clinically Stable Patients With Left-ventricular Dysfunction
A Phase 2 study testing BAY1142524 in people with Heart Failure, run by Bayer at 10 sites in 3 countries.
Trial summary
The purpose of the trial is the analysis of safety and tolerability of the chymase inhibitor BAY1142524 in comparison to placebo using a 2 weeks treatment period in clinically stable patients with left-ventricular dysfunction after myocardial infarction. Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- BAY1142524
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Jul 2015to Mar 2016
- 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 40 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically stable patients with left-ventricular dysfunction (LVEF ≤ 45%) after myocardial infarction, whereby the MI occurred 6 or more months before randomization.
- New York Heart Association (NYHA) class I-II.
- Left-ventricular ejection fraction ≤ 45%, confirmed by any imaging technique within the last 3 months prior to screening visit will be accepted for screening purposes. If no data are available, an echocardiography has to be performed at screening for inclusion.
- Treatment with evidence-based therapy for left-ventricular dysfunction post MI for at least 4 weeks prior to screening visit. This therapy has to include at least an Angiotensin-converting enzyme (ACE) inhibitor or an Angiotensin receptor blockers (ARB). Beta-blockers, diuretics, mineralocorticoid receptor antagonist (MRAs), antiplatelet therapy, statins, and aspirin are to be used if indicated. Treatment with stable doses of ACE inhibitors or ARBs using at least half of the recommended target dose (as defined in the European Society of Cardiology (ESC) guidelines, see appendix 16.4) ≥ 4 weeks prior to the screening visit is mandatory.
- No planned changes to post MI drug therapy during the active treatment phase of the study.
- Men or confirmed postmenopausal women (defined as being amenorrheic for longer than 2 years with an appropriate clinical profile, e.g. age appropriate and a history of vasomotor symptoms) or women without childbearing potential based on surgical treatment such as bilateral tubal ligation, bilateral oophorectomy or hysterectomy (documented by medical report verification).
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- Men of reproductive potential must agree to use 2 reliable and acceptable methods for contraception simultaneously when sexually active and not to act as sperm donor. This applies for the time period between signing of the informed consent form and 12 weeks after the last administration of study drug.
- Acceptable methods of contraception include, but are not limited to, (i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intra-uterine device; (iv) hormone-based contraception.
- Age: 40 to 79 years (inclusive) at the screening visit.
- Race: Caucasian
Who cannot join
- Non-ischemic causes for cardiomyopathy will be excluded (including, but not limited to: primary cardiomyopathy, constrictive, restrictive or hypertrophic cardiomyopathy, acute myocarditis, cardiomyopathy secondary to cardiotoxic chemotherapeutic agents).
- Hospitalization for decompensated heart failure within the last 3 months prior to randomization.
- Coronary revascularization within 6 weeks prior to randomization or if revascularization is anticipated or needed during the study duration.
- Clinically relevant, cardiac ischemia in a stress test within 3 months before screening.
- Patients carrying implantable cardioverter defibrillators, cardiac resynchronisation therapy devices or left ventricular assist devices that had any significant clinical events requiring treatment or changes to background medical therapy such as ventricular tachycardias, ventricular fibrillation in the last 6 months before randomization while carrying the devices
- Primary and uncorrected valvular disease with foreseen requirement of valve repair within the next 6 months.
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- Any stroke, TIA, any acute coronary syndrome within 6 months prior to randomization.
- Clinically relevant hepatic dysfunction at the screening visit indicated by at least one of the following:
- hepatic insufficiency (Child-Pugh B or C) as documented in medical history
- total bilirubin > 2 times the upper limit normal (ULN) and
- alanine amino transferase (ALT) > 3 times the ULN or
- glutamate dehydrogenase (GLDH) > 3 times the ULN or
- gamma glutamyl transpeptidase (GGT) > 5 times the ULN.
- Systolic blood pressure below 100 or above 160 mm Hg at the screening visit based on the average of 3 readings taken from the arm with the highest recordings.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Denmark4 sites
Study site
Copenhagen, DK-2400
Study site
Copenhagen Ø, 2100
Study site
Hellerup, 2900
Study site
Herlev, 2730
Germany4 sites
Study site
Berlin, 13353
Study site
Düsseldorf, North Rhine-Westphalia, 40225
Study site
Erfurt, Thuringia, 99084
Study site
Frankfurt am Main, Hesse, 60594
Italy2 sites
Study site
Bergamo, Lombardy, 24127
Study site
Brescia, Lombardy, 25123
About this study
Official title: A Single-blind, Multicenter Pilot Study to Investigate the Safety and Tolerability of a 14 Day Oral Treatment With Different Doses of the Chymase Inhibitor BAY1142524 in Comparison to Placebo in Clinically Stable Patients With Left-ventricular Dysfunction After Myocardial Infarction
The purpose of the trial is the analysis of safety and tolerability of the chymase inhibitor BAY1142524 in comparison to placebo using a 2 weeks treatment period in clinically stable patients with left-ventricular dysfunction after myocardial infarction. BAY1142524 or placebo will be given on top of evidence-based standard of care for left-ventricular dysfunction after myocardial infarction. Primary objectives are the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. BAY1142524 will be administered in a parallel group design using four doses (5, 10, 25 mg twice daily, and 50 mg once daily). Each dose group consists of 9 patients treated with verum and 3 patients treated with placebo.
- Conditions
- Heart Failure
- Being tested
- BAY1142524, Placebo
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1142524Drug
5 mg BAY1142524 or placebo given as 5 mg IR tablet twice daily for 2 weeks
BAY1142524Drug
10 mg BAY1142524 or placebo given as 2 x 5 mg IR tablets twice daily as for 2 weeks
BAY1142524Drug
25 mg BAY1142524 or placebo given as 5 x 5 mg IR tablets twice daily for 2 weeks
BAY1142524Drug
50 mg BAY1142524 or placebo given 1 x 50 mg IR tablet once daily for 2 weeks
PlaceboDrug
The patients will be treated orally with combinations of IR tablets containing placebo to achieve the indicated dosages.
| Study group | Role | What they receive |
|---|---|---|
| BAY1142524 (5 mg) | Experimental | 12 patients with left-ventricular dysfunction after myocardial infarction, 9 patients allocated to verum treatment, 3 patients allocated to placebo treatment Receives: Drug: BAY1142524; Drug: Placebo |
| BAY1142524 (10 mg) | Experimental | 12 patients with left-ventricular dysfunction after myocardial infarction, 9 patients allocated to verum treatment, 3 patients allocated to placebo treatment Receives: Drug: BAY1142524; Drug: Placebo |
| BAY1142524 (25 mg) | Experimental | 12 patients with left-ventricular dysfunction after myocardial infarction, 9 patients allocated to verum treatment, 3 patients allocated to placebo treatment Receives: Drug: BAY1142524; Drug: Placebo |
| BAY1142524 (50 mg) | Experimental | 12 patients with left-ventricular dysfunction after myocardial infarction, 9 patients allocated to verum treatment, 3 patients allocated to placebo treatment Receives: Drug: BAY1142524; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: Up to 20 days
Number of participants with serious adverse events
Measured: Up to 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2016
- Study completionMar 2016
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 49 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
- NCT02452515
- Sponsor's protocol ID
- 17055
- Other IDs
- 2014-005297-12, 2014
- Acronym
- CHIARA MIA 1
- Status last verified
- Mar 2017
- First submitted
- 20 May 2015
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind, Multicenter Pilot Study to Investigate the Safety and Tolerability of a 14 Day Oral Treatment With Different Doses of the Chymase Inhibitor BAY1142524 in Comparison to Placebo in Clinically Stable Patients With Left-ventricular Dysfunction After Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02452515
- Acronym / sponsor ID
- CHIARA MIA 1 / 17055
- Conditions
- Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 22 May 2015 (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.
The purpose of the trial is the analysis of safety and tolerability of the chymase inhibitor BAY1142524 in comparison to placebo using a 2 weeks treatment period in clinically stable patients with left-ventricular dysfunction after myocardial infarction. BAY1142524 or placebo will be given on top of evidence-based standard of care for left-ventricular dysfunction after myocardial infarction. Primary objectives are the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. BAY1142524 will be administered in a parallel group design using four doses (5, 10, 25 mg twice daily, and 50 mg once daily). Each dose group consists of 9 patients treated with verum and 3 patients treated with placebo.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BAY1142524 (5 mg) | Experimental | Drug: BAY1142524, Drug: Placebo12 patients with left-ventricular dysfunction after myocardial infarction, 9 patients allocated to verum treatment, 3 patients allocated to placebo treatment |
| BAY1142524 (10 mg) | Experimental | Drug: BAY1142524, Drug: Placebo12 patients with left-ventricular dysfunction after myocardial infarction, 9 patients allocated to verum treatment, 3 patients allocated to placebo treatment |
| BAY1142524 (25 mg) | Experimental | Drug: BAY1142524, Drug: Placebo12 patients with left-ventricular dysfunction after myocardial infarction, 9 patients allocated to verum treatment, 3 patients allocated to placebo treatment |
| BAY1142524 (50 mg) | Experimental | Drug: BAY1142524, Drug: Placebo12 patients with left-ventricular dysfunction after myocardial infarction, 9 patients allocated to verum treatment, 3 patients allocated to placebo treatment |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Clinically stable patients with left-ventricular dysfunction (LVEF ≤ 45%) after myocardial infarction, whereby the MI occurred 6 or more months before randomization.
- Men of reproductive potential must agree to use 2 reliable and acceptable methods for contraception simultaneously when sexually active and not to act as sperm donor. This applies for the time period between signing of the informed consent form and 12 weeks after the last administration of study drug.
- Acceptable methods of contraception include, but are not limited to, (i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intra-uterine device; (iv) hormone-based contraception.
- Age: 40 to 79 years (inclusive) at the screening visit.
- Race: Caucasian
Key exclusion criteria (14 listed)
- Non-ischemic causes for cardiomyopathy will be excluded (including, but not limited to: primary cardiomyopathy, constrictive, restrictive or hypertrophic cardiomyopathy, acute myocarditis, cardiomyopathy secondary to cardiotoxic chemotherapeutic agents).
- Hospitalization for decompensated heart failure within the last 3 months prior to randomization.
- Coronary revascularization within 6 weeks prior to randomization or if revascularization is anticipated or needed during the study duration.
- Clinically relevant, cardiac ischemia in a stress test within 3 months before screening.
- Patients carrying implantable cardioverter defibrillators, cardiac resynchronisation therapy devices or left ventricular assist devices that had any significant clinical events requiring treatment or changes to background medical therapy such as ventricular tachycardias, ventricular fibrillation in the last 6 months before randomization while carrying the devices
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 |
|---|---|---|
| BAY11425245 mg BAY1142524 or placebo given as 5 mg IR tablet twice daily for 2 weeks | Drug | BAY1142524 (5 mg) |
| BAY114252410 mg BAY1142524 or placebo given as 2 x 5 mg IR tablets twice daily as for 2 weeks | Drug | BAY1142524 (10 mg) |
| BAY114252425 mg BAY1142524 or placebo given as 5 x 5 mg IR tablets twice daily for 2 weeks | Drug | BAY1142524 (25 mg) |
| BAY114252450 mg BAY1142524 or placebo given 1 x 50 mg IR tablet once daily for 2 weeks | Drug | BAY1142524 (50 mg) |
| PlaceboThe patients will be treated orally with combinations of IR tablets containing placebo to achieve the indicated dosages. | Drug | BAY1142524 (10 mg), BAY1142524 (25 mg), BAY1142524 (5 mg), BAY1142524 (50 mg) |
Primary outcome
Number of participants with adverse events
Time frame: Up to 20 days
Number of participants with serious adverse events
Time frame: Up to 20 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
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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
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BAY1142524 in people with Heart Failure, run by Bayer at 10 sites in 3 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 10 inclusion and 14 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: finished, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Denmark, Germany, Italy. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with adverse events (time frame: Up to 20 days). The study lists 2 primary outcomes in all. 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 7 Nov 2017.