check_circleStudy Completed
Heart Failure
Bayer Identifier:
16782
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Multiple dose study in heart failure of BAY 1067197
Trial purpose
This is a study to investigate the safety, tolerability and early effects on cardiac function of the partial A1 agonist BAY1067197 in patients with chronic heart failure. BAY1067197 will be applied once daily over 7 days in addition to standard therapy including a beta-blocker. The aim of the study is to assess if a 7 day treatment with BAY1067197 is well tolerated when given on top of standard therapy for heart failure. Furthermore, the study aims to assess if cardiac function improves in the early course of therapy.
Key Participants Requirements
Sex
BothAge
18 - 75 YearsTrial summary
Enrollment Goal
31Trial Dates
January 2014 - April 2015Phase
Phase 2Could I Receive a placebo
YesProducts
Neladenoson Bialanate (BAY1067197)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Berlin, 13353, Germany | |
Completed | Wroclaw, 50-981, Poland | |
Completed | GRONINGEN, 9713 GZ, Netherlands | |
Completed | Bergamo, 24127, Italy | |
Withdrawn | Milano, 20162, Italy | |
Completed | Brescia, 25123, Italy | |
Completed | Milano, 20138, Italy |
Primary Outcome
- Number of Subjects With Relevant Changes in Heart RateHeart rate was measured by monitor measurements after 30 minutes resting in a supine position. The relevant changes in heart rate were recorded and analysed.date_rangeTime Frame:From the start of study treatment up to Day 29enhanced_encryptionYesSafety Issue:
- Number of Subjects With Relevant Changes in Blood PressureBlood pressure was measured by monitor measurements after 30 minutes resting in a supine position. The relevant changes in blood pressure were recorded and analysed.date_rangeTime Frame:From the start of study treatment up to Day 29enhanced_encryptionYesSafety Issue:
- Number of Subjects With More than First Degree Atrio-Ventricular (AV) BlockA complete standard 12-lead ECG was recorded and evaluated parameters such as heart rate, PR/PQinterval, QRSD interval, QT interval (uncorrected). Clinically relevant findings in ECG such as a second degree AV-block Mobitz type I (Wenkebach), Mobitz type II - or any third-degree AV block were recorded and reported. A 24-hour Holter ECG was recorded with a standard Holter ECG recorder for the purpose of detecting AV blocks, no higher degree AV blocks > 1 or clinically relevant effect on HR were observed during Holter monitoring periods.date_rangeTime Frame:After 7 day tratment and day 28enhanced_encryptionYesSafety Issue:
- Change From Baseline in Left Ventricular Ejection Fraction (LVEF)The change in LVEF between the post and the pre-treatment measurements were analyzed using Bayesian statistics to quantify the difference between BAY1067197 treatment and placebo measured by CMR. LVEF is the fraction of blood (in percent) pumped out of the heart’s left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart.date_rangeTime Frame:Baseline to day 7enhanced_encryptionNoSafety Issue:
- Maximum Observed Concentration of BAY84-3174 in Plasma (Cmax) After First Dose of BAY1067197Maximum observed BAY84-3174 concentration in plasma, directly taken from analytical data. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:Day 1: pre-dose and 0.5, 1, 2, 3, 4, 6, 12 and 24 hours post-doseenhanced_encryptionNoSafety Issue:
- Maximum Observed Concentration of BAY84-3174 in Plasma Divided by Dose (Cmax/D) After First Dose of BAY1067197Maximum observed drug concentration, directly taken from analytical data, divided by dose. Geometric mean and %CV were reported.date_rangeTime Frame:Day 1: pre-dose and 0.5, 1, 2, 3, 4, 6, 12 and 24 hours post-doseenhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve of BAY84-3174 for the Dosing Interval (AUCtau) After First Dose of BAY1067197AUCtau is defined as area under the plasma concentration time profile from time zero to the end of the dosing interval after the first dose and dosing interval was 24 h for both arms. Geometric mean and %CV were reported.date_rangeTime Frame:Day 1: pre-dose and 0.5, 1, 2, 3, 4, 6, 12 and 24 hours post-doseenhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve of BAY84-3174 for the Dosing Interval Divided by Dose (AUCtau/D) After First Dose of BAY1067197AUCtau/D is defined as area under the plasma concentration time profile from time zero to the end of the dosing interval divided by dose after the first dose and dosing interval was 24 h for both arms. Geometric mean and %CV were reported.date_rangeTime Frame:Day 1: pre-dose and 0.5, 1, 2, 3, 4, 6, 12 and 24 hours post-doseenhanced_encryptionNoSafety Issue:
- Maximum Observed Concentration of BAY84-3174 in Plasma (Cmax,md) After Multiple Dose Administration During a Dosing IntervalCmax,md is defined as maximum observed drug concentration in plasma after multiple-dose administrations during a dosing interval directly taken from analytical data.Geometric mean and %CV were reported.date_rangeTime Frame:Day 7: pre dose and 0.5, 1, 2, 3, 4, 6 and 12 hours post dose; Day 8, Day 14, Day 22 and Day 29enhanced_encryptionNoSafety Issue:
- Maximum Observed Concentration of BAY84-3174 in Plasma Divided by Dose (Cmax,md/D) After Multiple Dose Administration During a Dosing IntervalMaximum observed drug concentration, directly taken from analytical data divided by dose after multiple doses. Geometric mean and %CV were reported.date_rangeTime Frame:Day 7: pre dose and 0.5, 1, 2, 3, 4, 6 and 12 hours post dose; Day 8, Day 14, Day 22 and Day 29enhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve of BAY84-3174 During any Dosing Interval (AUCtau,md) After Multiple Dose AdministrationAUCtau,md is defined as area under the plasma concentration time profile from time zero during the dosing interval after multiple-dose administrations and dosing interval was 24 h for both arms. Geometric mean and %CV were reported.date_rangeTime Frame:Day 7: pre-dose and 0.5, 1, 2, 3, 4, 6, 12 and 24 hours post-doseenhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve of BAY84-3174 During any Dosing Interval Divided by Dose (AUCtau,md/D) After Multiple Dose AdministrationAUCtau,md/D is defined as area under the plasma concentration time profile from time zero to the end of the dosing interval after multiple dose of administrations divided by dose and dosing interval was 24 h for both arms. Geometric mean and %CV were reported.date_rangeTime Frame:Day 7: pre-dose and 0.5, 1, 2, 3, 4, 6, 12 and 24 hours post-doseenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Changes From Baseline for Wall Motion Score Index at Day (WMSI) as Measured by Cardiac Magnetic Resonance at Day 7Wall motion score index will cover the changes in wall motion score from baseline also.date_rangeTime Frame:Baseline to day 7enhanced_encryptionNoSafety Issue:
- Number of Subjects With Clinically Relevant Changes Observed in Echocardiography ParametersSeptal mitral annulus (e’ septal), Lateral mitral annulus (e’ lateral), E/e’ average (average of e’ lateral and e’ septal), E/e’ Lateral ratio, E/e’ Septal ratio, Peak early doppler transmitral flow velocity (E), Peak atrial doppler transmitral flow velocity (A), E/A Ratio, Deceleration time (DT), Global longitudinal strain, Cardiac output, Stroke volume, Stroke volume index, Peak systolic tissue Doppler Velocity (Smax), Left ventricular end-systolic volume (LVESV), Left ventricular enddiastolic volume (LVEDV), Left atrial volume index (LAVI), Peak pulmonary systolic pressure (PAPsys).date_rangeTime Frame:Baseline, Day 6 and 15enhanced_encryptionYesSafety Issue:
- Number of Subjects With Clinically Relevant Changes Observed in BiomarkersN-terminal prohormone of brain natriuretic peptide (NT-proBNP), renin, mid-region pro-atrial natriuretic peptide (MR-proANP) are biomarkers which show effect on neurohormones.date_rangeTime Frame:Baseline up to Day 15enhanced_encryptionYesSafety Issue:
- Time to Reach Maximum Observed Concentration of BAY84-3174 in Plasma (tmax) After First Dose of BAY1067197Time to reach maximum drug concentration in the measured matrix, directly taken from analytical datadate_rangeTime Frame:Day 1: pre-dose and 0.5, 1, 2, 3, 4, 6, 12 and 24 hours post-doseenhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve of BAY84-3174 for the Dosing Interval Divided by Dose per Body Weight (AUCtau,md,norm) After Multiple Dose AdministrationAUCtau,md,norm is defined as area under the plasma concentration time profile from time zero to the end of the dosing interval after multiple dosing divided by dose per body weight. The dosing interval was 24 h for both arms. Geometric mean and %CV were reported.date_rangeTime Frame:Day 7: pre-dose and 0.5, 1, 2, 3, 4, 6, 12 and 24 hours post-doseenhanced_encryptionNoSafety Issue:
- Maximum Observed Concentration of BAY84-3174 in Plasma Divided by Dose per Body Weight (Cmax,md,norm) After Multiple Dose AdministrationCmax,md,norm defined as maximum observed drug concentration in plasma after the first dose followed by multiple-dose administrations during a dosing interval divided by dose per body weight. Geometric mean and %CV were reported.date_rangeTime Frame:Day 7: pre dose and 0.5, 1, 2, 3, 4, 6 and 12 hours post dose; Day 8, Day 14, Day 22 and Day 29enhanced_encryptionNoSafety Issue:
- Time to Reach Maximum Observed Concentration of BAY84-3174 in Plasma (tmax,md) After Multiple Dose Administrationtmax,md defines as time to reach maximum drug concentration in the measured matrix after multiple dose administrations directly taken from analytical data.date_rangeTime Frame:Day 7: pre dose and 0.5, 1, 2, 3, 4, 6 and 12 hours post dose; Day 8, Day 14, Day 22 and Day 29enhanced_encryptionNoSafety Issue:
- Half-Life Associated With the Terminal Slope (t1/2,md) After Multiple-Dose Administrationt1/2,md is defiend as time to reach maximum observed drug concentration in plasma after the first dose followed by multiple-dose administrations. Geometric mean and %CV were reported.date_rangeTime Frame:Day 7: pre dose and 0.5, 1, 2, 3, 4, 6 and 12 hours post dose; Day 8, Day 14, Day 22 and Day 29enhanced_encryptionNoSafety Issue:
- Maximum Observed Concentration of BAY84-3174 in Plasma After First Dose Divided by Dose per Body Weight (Cmax,norm)Cmax,norm is defined as maximum observed drug concentration in plasma after the first dose divided by dose per body weight. Geometric mean and %CV were reported.date_rangeTime Frame:Day 1: pre-dose and 0.5, 1, 2, 3, 4, 6, 12 and 24 hours post-doseenhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve of BAY84-3174 for the Dosing Interval Divided by Dose per Body Weight (AUCtau,norm) After First Dose of BAY1067197AUCtau,norm is defined as area under the plasma concentration time profile from time zero to the end of the dosing interval divided by dose per body weight after the first dose. Dosing interval was 24 h for both arms. Geometric mean and %CV were reported.date_rangeTime Frame:Day 1: pre-dose and 0.5, 1, 2, 3, 4, 6, 12 and 24 hours post-doseenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
4Additional Information
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