Efficacy of Oral Bisoprolol on Heart Rate Reduction in Chinese Chronic Heart Failure Participants

Phase 4TerminatedNCT03026088

Merck KGaA, Darmstadt, Germany20 enrolled

Overview

This is a single-arm, open label, interventional, multi-center, phase 4 pilot study.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure

Interventions

BisoprololDRUG

Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18-80 year, male or female. * Chronic Heart failure subjects with medical history of cardiac disease or other related cardiovascular disease. * Left ventricular ejection fraction (LVEF) less than or equal to (=\<) 40 percent (%). * New York Heart Association (NYHA) class of II - IV * NYHA II ： Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in undue breathlessness, fatigue or palpitation. * NYHA III：Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes undue breathlessness, fatigue or palpitation. * NYHA IV：Unable to carry on any physical activity without discomfort. Symptoms at rest can be present. If any physical activity is undertaken, discomfort increased. * Signed Informed Consent Form (ICF). Exclusion Criteria: * Acute coronary syndrome (ACS) within 3 months. * Under beta-blocker treatment for the last 2 weeks. * Under other medicine treatment which may affect heart rate, like Non-dihydropyridine calcium channel blockers (NDHP-CCBs) or ivabradine for the last 2 weeks; Under Digoxin treatment \[more than (\>) 0.125 milligram (mg)\]. * Uncontrolled Diabetes \[hemoglobin A1c, (HbA1c) \>7.5%\]. * Severe or uncontrolled hypertension \[resting Systolic Blood Pressure (SBP) \>180 millimeters of mercury (mmHg), or resting Diastolic Blood Pressure (DBP) \>110mmHg at screening period\]. * Severe hypotension \[resting SBP less than (\<) 90mmHg, or resting DBP\<50mmHg\]. * Resting heart rate \<60 beat per minute (bpm). * Any contradiction to Bisoprolol according to label, including: * Acute heart failure or during episodes of heart failure decompensation requiring intravenous inotropic therapy. * Cardiogenic shock. * Atrioventricular block of second or third degree (without a pacemaker). * Sick sinus syndrome. * Sinoatrial block. * Slowed heart rate, causing symptoms (symptomatic bradycardia), * Decreased blood pressure, causing symptoms (symptomatic hypotension), * Severe bronchial asthma or severe chronic obstructive pulmonary disease. * Sever forms of peripheral arterial occlusive disease and Raynaud's syndrome. * Untreated phaeochromocytoma. * Metabolic acidosis. * Hypersensitivity to bisoprolol or to any of the excipients. * Severe Arrhythmia including atrial fibrillation, atrial flutter, ventricular fibrillation, ventricular flutter or ventricular tachycardia. * Significant valvular heart disease, congenital heart disease, pulmonary heart disease or perinatal heart disease. * Acute pulmonary edema. * Severe hepatic dysfunction, defined as: * Serum Alanine Aminotransferase (ALT) \> triple the upper limit of the normal range; and/or * Serum Aspartate Aminotransferase (AST) \> triple the upper limit of the normal value range and/or * Severe renal dysfunction, defined as: * Serum creatinine \> twice the upper limit of the normal range * Chronic Kidney Disease (glomerular filtration rate \<45 Milliliter per minute). * Hyperthyroidism or hypothyroidism. * Severe infectious disease, example (eg) Human Immunodeficiency Virus positive or active tuberculosis. * Severe autoimmune disease, e.g. lupus erythematosus, multiple sclerosis. * Severe respiratory, digestive, hematological disease (including Anemia of Hb \< 100 gram per litre) or tumor. * Known to be hypersensitivity to Bisoprolol, or any of the excipient. * Substance or alcohol abuse. * Received heart transplantation or pacemaker implantation; revascularization treatment within 3 months; or plan to receive above treatment in 6 months. * Currently undertaking other treatment that may affect the safety and/or efficacy evaluation, e.g. beta receptors agonists, et cetera. * No legal ability or legal ability is limited. * Subjects unlikely to cooperate in the study or with inability or unwillingness to give informed consent. * Child-bearing period women without effective contraceptive measures, pregnancy and lactation. * Participation in another clinical trial within the past 90 days. * Other significant condition that in the Investigator's opinion would exclude the subject from the trial.

Locations (1)

Fuwai Hospital Chinese Academy of Medical Sciences

Beijing, China

Outcomes

Primary Outcomes

Change From Baseline in Resting Heart Rate at Week 6

Heartbeats in each minute were calculated and averaged to obtain the resting heart rate.

Time frame: Baseline, Week 6

Change From Baseline in Resting Heart Rate at Week 14

Heartbeats in each minute were calculated and averaged to obtain the resting heart rate.

Time frame: Baseline, Week 14

Change From Baseline in Resting Heart Rate at Week 26

Heartbeats in each minute were calculated and averaged to obtain the resting heart rate.

Time frame: Baseline, Week 26

Secondary Outcomes

Change From Baseline in Resting Heart Rate at Week 3, 10 and 18

Heartbeats in each minute were calculated and averaged to obtain the resting heart rate.

Time frame: Baseline, Week 3, 10 and 18

Left Ventricular Ejection Fraction (LVEF) at Baseline, Week 14 and 26

LVEF was defined as the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat and it is used to measure the cardiac output for the heart. Ultrasound cardiogram performed to measure LVEF.

Time frame: Baseline, Week 14 and 26

Left Ventricular End-Systolic Dimension (LVESD) at Baseline, Week 14 and 26

Left Ventricular End-Systolic Dimension was measured by Ultrasound cardiogram.

Time frame: Baseline, Week 14 and 26

Left Ventricular End-diastolic Dimension (LVEDD) at Baseline, Week 14 and 26

Left Ventricular End-diastolic Dimension was measured by Ultrasound cardiogram.

Data from ClinicalTrials.gov

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