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Research on the Simplified Treatment Protocol for Recovery DCM

Research on the Simplified Treatment Protocol for Recovery DCM

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099416
Enrollment
Unknown
Registered
2025-03-24
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-31

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

Conditions

Dilated cardiomyopathy

Interventions

Intervention group:Streamline regimens
Control group:Four pillar therapy for heart failure

Sponsors

Chinese Academy of Medical Sciences Fuwai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. Patients with dilated cardiomyopathy (DCM) aged =18 years, of either sex; 2. Patients who have achieved the standard of heart failure recovery with the new four-drug GDMT (or a three-drug regimen excluding MRA) for at least 6 months, and were evaluated at the time of enrollment to meet the standard of heart failure recovery, i.e., satisfying all of the following conditions: a. No typical symptoms and signs of heart failure in the past 6 months; b. An increase in LVEF of more than 10% and =50% within the past 6 months, and LVEDD<55mm; c. NT-proBNP<300pg/ml (for patients with eGFR<60ml/min/1.73m², NT-proBNP<450pg/ml); 3. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Poorly controlled hypertension, defined as resting systolic blood pressure >=160mmHg and/or diastolic blood pressure >=100mmHg at two independent examinations prior to randomization; 2. Hepatic transaminases (ALT or AST) not caused by heart failure, bilirubin exceeding 3 times the upper limit of normal, estimated glomerular filtration rate (GFR) less than 15ml/min/1.73m^2; 3. Patients with hemoglobin concentration = 2 times the upper limit of normal or aspartate aminotransferase (AST> = 2 times the upper limit of normal), active hepatitis B hepatic insufficiency (ALT> = 2 times the upper limit of normal or aspartate aminotransferase (AST>=2 times the upper limit of normal), patients with active tuberculosis, etc.; 23. Patients with clearly diagnosed systemic diseases and autoimmune diseases, such as systemic lupus erythematosus and severe asthma; 24. Those who have participated in other drug clinical studies within 2 months; 25. Pregnancy (positive pregnancy test) or lactation; Childbearing age who a

Design outcomes

Primary

MeasureTime frame
Composite endpoint of heart failure recurrence or heart failure events (hospitalization for heart failure, cardiovascular death);

Secondary

MeasureTime frame
Total number of hospitalizations for heart failure;Number of emergency or hospital admissions due to worsening heart failure;Cardiovascular death;All-cause mortality;

Countries

China

Contacts

Public ContactYuhui Zhang

Chinese Academy of Medical Sciences Fuwai Hospital

yuhuizhangjoy@163.com+86 10 6833 1877

Outcome results

None listed

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