Heart FailurePhase 2NCT01945606
Study to Assess the Safety of BAY1067197 in Stable Heart Failure Patients on Standard Therapy Including ß-blocker
A Phase 2 study testing BAY1067197 (treatment 2) in people with Heart Failure, run by Bayer at 1 site in Netherlands.
Trial summary
This is a study to investigate the safety and tolerability of the partial A1 agonist BAY1067197 in patients with chronic heart failure. BAY1067197 will be applied as a single dose of 30 mg in addition to standard therapy including a beta-blocker. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- BAY1067197 (treatment 2)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 Nov 2013to 17 Mar 2015
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable systolic heart failure (heart failure with reduced ejection fraction, heart failure with reduced ejection fraction [HFrEF]; New York Heart Association [NYHA] I-III) in sinus rhythm with a documented ejection fraction (EF) ≤45% within the last 3 months
- Stable standard heart failure (HF) therapy including intermediate to high dose β-blocker with either ≥ 95 mg metoprolol succinate (controlled release tablet), ≥ 5mg Bisoprolol (immediate release [IR] -tablet) or ≥5mg Nebivolol (IR tablet) for at least 4 weeks. Additional intake of angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers and optional aldosterone-receptor antagonists, diuretics or digitalis is allowed
- 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 ovarectomy, or hysterectomy (documented by medical report verification). Men enrolled in this study must agree to use adequate barrier birth control measures during the treatment period of the study and for 12 weeks after receiving the investigational medicinal product (IMP)
- Male patients must agree not to act as sperm donor for 12 weeks after dosing
- Ethnicity: White
- Body mass index (BMI): above/equal 18.0 and below/equal 29.9 kg/m²
- Age: 18 to 75 years (inclusive) at the first screening visit
Who cannot join
- Biventricular pacing/active cardiac resynchronization therapy (CRT) device
- Dependency on pacemaker or implantable cardioverter-defibrillator (ICD) device with pacemaker dependency (a paced ventricular rhythm > 5% of heart activity)
- A history of relevant diseases of vital organs other than the heart, of the central nervous system or other organs
- Known hypersensitivity to the study preparations (active substances or excipients of the preparations) or to any other β-blocker
- Current or history of AV-Block > I°
- Unstable condition, indicated by requirement of IV drug (diuretic, inotrope, etc.) or NYHA IV
Show all 9Show fewer
- Acute Coronary Syndrome (defined as unstable angina [UA], non-ST elevation myocardial infarction [NSTEMI], ST elevation myocardial infarction [STEMI]) within 3 months prior to first study drug administration
- History of asthma or chronic obstructive pulmonary disease (COPD) ≥ global initiative for chronic obstructive lung disease (GOLD) II and/or allergic asthma
- Women of childbearing potential, pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Blind, Placebo Controlled Pilot Study to Explore the Safety and Tolerability of a Single Oral Dose of 30 mg BAY1067197 in Patients With Chronic Heart Failure on the Background of Preexisting Beta-blocker Therapy
This is a study to investigate the safety and tolerability of the partial A1 agonist BAY1067197 in patients with chronic heart failure. BAY1067197 will be applied as a single dose of 30 mg in addition to standard therapy including a beta-blocker. The aim of the study is to assess if a single oral dose of 30 mg BAY1067197 is well tolerated when given on top of standard therapy for heart failure, particularly ß-blocker treatment.
- Conditions
- Heart Failure
- Being tested
- Placebo (treatment 1), BAY1067197 (treatment 2)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (treatment 1)Drug
Oral administration of placebo tablets
BAY1067197 (treatment 2)Drug
Oral administration of a single dose of 30 mg (3×10 mg Tablet) BAY1067197
| Study group | Role | What they receive |
|---|---|---|
| Placebo and BAY1067197 | Experimental | Patients will get both treatment 1 and 2 Receives: Drug: Placebo (treatment 1); Drug: BAY1067197 (treatment 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with occurrence of AV-Block > I°
Measured: up to 48 hours
Secondary outcomes (5)
Pharmacokinetic profile determined by tmax
Measured: up to 24 hours
Pharmacokinetic profile determined by t1/2
Measured: up to 22 days
Heart rate
Measured: multiple time points up to 24 hours
Blood pressure
Measured: multiple time points up to 24 hours
Number of participants with adverse events as a measure of safety and tolerability
Measured: up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study start29 Nov 2013
- Primary completion9 Sep 2014
- Study completion17 Mar 2015
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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 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
- NCT01945606
- Sponsor's protocol ID
- 16718
- Other IDs
- 2013-001287-34
- Status last verified
- Sep 2019
- First submitted
- 16 Sep 2013
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blind, Placebo Controlled Pilot Study to Explore the Safety and Tolerability of a Single Oral Dose of 30 mg BAY1067197 in Patients With Chronic Heart Failure on the Background of Preexisting Beta-blocker Therapy
- ClinicalTrials.gov ID
- NCT01945606
- Acronym / sponsor ID
- 16718
- Conditions
- Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2013 (actual)
- Primary completion
- 9 Sep 2014 (actual)
- Study completion
- 17 Mar 2015 (actual)
- First posted
- 18 Sep 2013 (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.
This is a study to investigate the safety and tolerability of the partial A1 agonist BAY1067197 in patients with chronic heart failure. BAY1067197 will be applied as a single dose of 30 mg in addition to standard therapy including a beta-blocker. The aim of the study is to assess if a single oral dose of 30 mg BAY1067197 is well tolerated when given on top of standard therapy for heart failure, particularly ß-blocker treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Placebo and BAY1067197 | Experimental | Drug: Placebo (treatment 1), Drug: BAY1067197 (treatment 2)Patients will get both treatment 1 and 2 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Stable systolic heart failure (heart failure with reduced ejection fraction, heart failure with reduced ejection fraction [HFrEF]; New York Heart Association [NYHA] I-III) in sinus rhythm with a documented ejection fraction (EF) ≤45% within the last 3 months
- Stable standard heart failure (HF) therapy including intermediate to high dose β-blocker with either ≥ 95 mg metoprolol succinate (controlled release tablet), ≥ 5mg Bisoprolol (immediate release [IR] -tablet) or ≥5mg Nebivolol (IR tablet) for at least 4 weeks. Additional intake of angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers and optional aldosterone-receptor antagonists, diuretics or digitalis is allowed
- 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 ovarectomy, or hysterectomy (documented by medical report verification). Men enrolled in this study must agree to use adequate barrier birth control measures during the treatment period of the study and for 12 weeks after receiving the investigational medicinal product (IMP)
- Male patients must agree not to act as sperm donor for 12 weeks after dosing
- Ethnicity: White
Key exclusion criteria (9 listed)
- Biventricular pacing/active cardiac resynchronization therapy (CRT) device
- Dependency on pacemaker or implantable cardioverter-defibrillator (ICD) device with pacemaker dependency (a paced ventricular rhythm > 5% of heart activity)
- A history of relevant diseases of vital organs other than the heart, of the central nervous system or other organs
- Known hypersensitivity to the study preparations (active substances or excipients of the preparations) or to any other β-blocker
- Current or history of AV-Block > I°
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 |
|---|---|---|
| Placebo (treatment 1)Oral administration of placebo tablets | Drug | Placebo and BAY1067197 |
| BAY1067197 (treatment 2)Oral administration of a single dose of 30 mg (3×10 mg Tablet) BAY1067197 | Drug | Placebo and BAY1067197 |
Primary outcome
Number of patients with occurrence of AV-Block > I°
Time frame: up to 48 hours
5 secondary outcomes
Pharmacokinetic profile determined by tmax
Time frame: up to 24 hours
Pharmacokinetic profile determined by t1/2
Time frame: up to 22 days
Heart rate
Time frame: multiple time points up to 24 hours
Blood pressure
Time frame: multiple time points up to 24 hours
Number of participants with adverse events as a measure of safety and tolerability
Time frame: up to 48 hours
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 19 Sep 2019.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BAY1067197 (treatment 2) in people with Heart Failure, run by Bayer at 1 site in Netherlands.
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 7 inclusion and 9 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 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 patients with occurrence of AV-Block > I° (time frame: up to 48 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 19 Sep 2019.