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

NCT03026088 | Terminated Phase 4 Results

• 1 other identifier: MS200006-0039
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure

Keywords

Chronic Heart Failure; Bisoprolol; Heart rate control

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Resting Heart Rate at Week 6

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

  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.

  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.

  Baseline, Week 26

Secondary Outcomes (18)

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

  Baseline, Week 3, 10 and 18

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

  Baseline, Week 14 and 26

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

  Baseline, Week 14 and 26

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

  Baseline, Week 14 and 26

• Interventricular Septal Thickness (IVST) at Baseline, Week 14 and 26

  Baseline, Week 14 and 26

Study Arms (1)

Bisoprolol

EXPERIMENTAL

Drug: Bisoprolol

Interventions

Bisoprolol DRUG

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.

Also known as: Brand name: Concor

Bisoprolol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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),

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Serono Co., Ltd., China: collaborator

Study Sites (1)

Fuwai Hospital Chinese Academy of Medical Sciences

Beijing, 100037, China

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Bisoprolol

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Limitations and Caveats

The study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants.

Results Point of Contact

• Title: Communication Center
• Organization: Merck KGaA, Darmstadt, Germany

service@emdgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck Serono Co., Ltd., China

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 20, 2017
• Study Start: March 21, 2017
• Primary Completion: December 26, 2018
• Study Completion: December 26, 2018
• Last Updated: January 29, 2020
• Results First Posted: January 29, 2020

Record last verified: 2020-01

Locations

CN (1)