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Pharmacological Treatment Strategy for heart failure in patients with recovered dilated cardiomyopathy: a randomised control trial

Pharmacological Treatment Strategy for heart failure in patients with recovered dilated cardiomyopathy: a randomised control trial - SIMPLE-HF

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058166
Enrollment
Unknown
Registered
2022-03-31
Start date
2022-04-11
Completion date
Unknown
Last updated
2023-12-10

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

Conditions

Heart Failure Dilated Cardiomyopathy

Interventions

Simplified Treatment Group:Simplified Treatment

Sponsors

Fuwai Hospital, CAMS & PUMC
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age 50mm (female) or >55mm (male); NT-proBNP > 300 pg/ml; 4. Patients are taking three or more standard medications, which include: Angiotensin converting enzyme inhibitor (ACEI)/angiotensin receptor blocker (ARB)/ Angiotensin II Receptor Blocker Neprilysin Inhibitor (ARNI), beta-receptor blocker, mineralocorticoid receptor antagonist (MRA), diuretic, etc. Treatment is determined according to clinical conditions; 5. Heart failure recovery, with all the following conditions were met: (1) absence of signs and symptoms of heart failure; (2) LVEF>50%, and LVEDD=20 ml/kg/min; 6. Has provided informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients have the following cardiovascular diseases: familial dilated cardiomyopathy, valvular heart disease, coronary heart disease, other cardiomyopathies, pulmonary vascular disease, congenital heart disease, other heart diseases requiring surgical interventions, uncorrected arrhythmia, indicated for or has been treated with ICD/CRT/CRTD; 2. Patients with uncontrolled blood pressure >140/90mmHg; Diuretics and/or aldosterone receptor antagonists should be taken by the patients; 3. Uncontrolled rapid supraventricular/ventricular arrhythmias such as atrial flutter, atrial fibrillation, atrial tachycardia, ventricular tachycardia etc; 4. Patients are complicated by other diseases that need diuretics and aldosterone receptor antagonist treatment; 5. Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2; 6. Complicated with other systemic diseases that require repeated hospitalization and influence survival, such as malignancies with short life expectancy, autoimmune diseases, infectious diseases, hematological diseases, thrombotic diseases (DVT, pulmonary embolism), cerebrovascular diseases (stroke, hemorrhage, aneurysm), etc; 7. Patients refuse to have blood samples taken and could not comply with clinical follow-up; 8. Patients have poor compliance, such as being unable to adhere to medications or abstaining from susceptible factors, such as alcohol, or pregnancy; 9. Patients have other conditions that are not suitable for this study, judged by the clinicians.

Design outcomes

Primary

MeasureTime frame
The rate of maintaining cardiac recovery status within 1 year;

Secondary

MeasureTime frame
Heart failure rehospitalization within 1 year;Quality of life score;Cardiopulmonary exercise test peakVO2;Cardiovascular mortality within 1 year;All-cause mortality within 1 year;

Countries

China

Contacts

Public ContactYunhong Wang

Fuwai Hospital, CAMS & PUMC

wangstyle@126.com+86 13436862717

Outcome results

None listed

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