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An open, prospective,multicenter,parallel arm,randomized controlled trial to assess the efficacy of beta-block agent for heart failure patients of left ventricle ejection fraction>40%

An open, prospective,multicenter,parallel arm,randomized controlled trial to assess the efficacy of beta-block agent for heart failure patients of left ventricle ejection fraction>40%

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-08000144
Enrollment
Unknown
Registered
2008-08-22
Start date
2008-01-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure of left ventricle ejection fraction>40%

Interventions

control group:orthodox drug treatment for heart failure, in cluding single or alliance therapy by diuretic agent, ACEI, apresoline, prolonged action nitrate, ARB and cardiotonic glycoside
research group:amber acid metoprolol + orthodox drug treatment for heart failure, in cluding single or alliance therapy by diuretic agent, ACEI, apresoline, prolonged action nitrate, ARB and cardioton

Sponsors

Zhongshan Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 40-80 years; 2. Patients with hart failure of NYHA II-IV for more than 3 months; 3. Patients' left ventricle ejection fraction>40%; 4. Patients' NTproBNP>1500pg/ml5.Patients are receiving orthodox drug treatment for heart failure, in cluding single or alliance therapy by diuretic agent, ACEI, apresoline, prolonged action nitrate, ARB and cardiotonic glycoside, for more than 2 weeks when randomization; 6. Patients could be followed up in out-patient clinic; 7. Signed informed consent for the study.

Exclusion criteria

Exclusion criteria: 1. Women of childbearing potrntial without adequate birthcontrol; 2. Unstable angina pectoris or myocardial infarction during the last 28 days; 3. History of sinus bradycardia, heart rate<55 beats per minute; 4. Must be treated by beta-block agent or have the counterindication of beta-block agent 5. Heart failure caused by (1) obstructive hypertrophic cardiomyopathy (cardiomyopathy nonobstructive, include apical hypertrophic cardiomyopathy could be involved); (2) restrictive cardiomyopathy; (3) congenital cardiopathy; (4) Clinically overt primary valvular heart disease can not be retrieved; (5) heart valve prosthesis functional defect; (6) pericardial disease; (7) systemic disease (for example: systemic disease or amyloid degeneration); 6. Traumatic treatment as (1) accepted CABG or PCI during the last 3 months or will accept CABG or PCI in 3 months; (2) implanted ICD or will Implant ICD; (3) accepted heart transplant or will accept heart transplant; 7. History of high degree atrio-ventricular block(second degree A-V block, third A-V block or sick sinus syndrome), unless the patient has been implanted pacemaker; 8. Unstable decompensation heart failure by adequate treatment,or occured hypotension (Bp<90/60mmHg, concomitant the symptom of dizziness, cold clammy limbs, diaphoresis and so on) at the time of randomization; 9. Any other serious diseases such as: (1) HIV infection; (2) malignant tumor; (3) overt primary Liver disease or Kidney disease; (4) alcohol or drug abuse; (5) bad compliance; 10. Previous (30 preceding days) or current participation another clinical trial.

Design outcomes

Primary

MeasureTime frame
deaths total rate;associate rate of hospitalization and death;

Secondary

MeasureTime frame
ejection fraction and heart function(classed by NY;

Countries

China

Contacts

Public ContactJunbo Ge
ge.junbo@zs-hospital.sh.cn+86 64041990-2745

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026