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Study to Assess the Safety of BAY1067197 in Stable Heart Failure Patients on Standard Therapy Including ß-blocker

Primary Purpose

Heart Failure

Status

Completed

Phase

Phase 2

Locations

Netherlands

Study Type

Interventional

Intervention

Placebo (treatment 1)

BAY1067197 (treatment 2)

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Placebo and BAY1067197

Arm Description

Patients will get both treatment 1 and 2

Outcomes

Primary Outcome Measures

Number of patients with occurrence of AV-Block > I°

Secondary Outcome Measures

Pharmacokinetic profile determined by tmax

Pharmacokinetic profile determined by t1/2

Heart rate

Blood pressure

Number of participants with adverse events as a measure of safety and tolerability

Full Information

NCT ID

NCT01945606

First Posted

September 16, 2013

Last Updated

September 17, 2019

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01945606

Brief Title

Study to Assess the Safety of BAY1067197 in Stable Heart Failure Patients on Standard Therapy Including ß-blocker

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

November 29, 2013 (Actual)

Primary Completion Date

September 9, 2014 (Actual)

Study Completion Date

March 17, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo and BAY1067197

Arm Type

Experimental

Arm Description

Patients will get both treatment 1 and 2

Intervention Type

Drug

Intervention Name(s)

Placebo (treatment 1)

Intervention Description

Oral administration of placebo tablets

Intervention Type

Drug

Intervention Name(s)

BAY1067197 (treatment 2)

Intervention Description

Oral administration of a single dose of 30 mg (3×10 mg Tablet) BAY1067197

Primary Outcome Measure Information:

Title

Number of patients with occurrence of AV-Block > I°

Time Frame

up to 48 hours

Secondary Outcome Measure Information:

Title

Pharmacokinetic profile determined by tmax

Time Frame

up to 24 hours

Title

Pharmacokinetic profile determined by t1/2

Time Frame

up to 22 days

Title

Heart rate

Time Frame

multiple time points up to 24 hours

Title

Blood pressure

Time Frame

multiple time points up to 24 hours

Title

Number of participants with adverse events as a measure of safety and tolerability

Time Frame

up to 48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Groningen

ZIP/Postal Code

9700 RB

Country

Netherlands

12. IPD Sharing Statement

Links:

URL

http://clinicaltrials.bayer.com/

Description

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Study to Assess the Safety of BAY1067197 in Stable Heart Failure Patients on Standard Therapy Including ß-blocker

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