Heart Failure Center Accreditation in China (HF-CAP Trial)

Fudan University

Status: Not yet enrolling

Conditions: Heart Failure

Treatments: Other: Usual Care; Other: Heart Failure Center Accreditation Program (HF-CAP)

Study type: Interventional

Funder types: Other

Identifiers

NCT07371780

B2025 -675

Details and patient eligibility

About

Heart failure is a common and serious condition that affects millions of people in China and worldwide. Although effective treatments and clinical guidelines are available, the quality of heart failure care varies across hospitals, and many patients do not receive optimal management in real-world practice.

The Heart Failure Center Accreditation Program (HF-CAP) is a national quality improvement initiative in China designed to standardize and improve the diagnosis, treatment, and follow-up care of patients hospitalized with heart failure. This study aims to evaluate whether implementation of the HF-CAP program improves the quality of heart failure management and clinical outcomes compared with usual care.

This is a prospective, multicenter, cluster randomized controlled trial conducted in hospitals across China. Hospitals will be randomly assigned to either the HF-CAP intervention group or the usual care group. Adult patients hospitalized primarily for heart failure will be enrolled and followed for 12 months after discharge.

The main outcomes of this study are (1) a composite of heart failure rehospitalization or all-cause mortality within 12 months after discharge, and (2) a heart failure management quality score. Secondary outcomes include heart failure rehospitalization, all-cause rehospitalization, and all-cause mortality.

The results of this study are expected to provide high-quality evidence on whether hospital-based accreditation and quality improvement programs can improve the care and outcomes of patients with heart failure in real-world clinical practice in China.

Enrollment: 6,240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Eligibility Criteria for Participating Centers

• The participating center must be registered on the China Heart Failure Center website.Institutions applying for standard-level or primary-level heart failure center accreditation are required to have reported at least 300 or 100 heart failure cases, respectively, and must continuously report at least 10 or 8 heart failure cases per month, respectively.
• The participating center must have the capability to implement quality improvement measures.

Eligibility Criteria for Participants

• Age 18 years or older.
• Heart failure is the primary reason for hospitalization.

Whether hospitalization is due to heart failure will be determined by local investigators, but must meet the following criteria:

i. Presence of symptoms of heart failure (such as dyspnea or fatigue), signs of heart failure (such as elevated jugular venous pressure or peripheral edema), or laboratory or imaging evidence, including but not limited to: Pulmonary congestion on chest X-ray, Elevated natriuretic peptide levels, Echocardiographic evidence of structural or functional cardiac abnormalities. ii. Receipt of treatment targeting acute or chronic heart failure etiology, such as intravenous diuretics, vasodilators, positive inotropic agents, or coronary revascularization.

Exclusion criteria

• Presence of a life-threatening condition unrelated to heart failure with an expected life expectancy of less than 1 year (for example, advanced malignancy).
• Inability to complete the planned follow-up assessments.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6,240 participants in 2 patient groups

HF-CAP Intervention

Experimental group

Description:

Hospitals assigned to this arm will implement the Heart Failure Center Accreditation Program (HF-CAP). The intervention includes standardized heart failure care processes, multidisciplinary team-based management, regular training of healthcare professionals, patient and caregiver education, structured discharge planning, and post-discharge follow-up, as well as continuous quality monitoring and feedback. Patients hospitalized for heart failure in these hospitals will receive care under the HF-CAP framework.

Treatment:

Other: Heart Failure Center Accreditation Program (HF-CAP)

Usual Care

Active Comparator group

Description:

Hospitals assigned to this arm will provide usual care for patients hospitalized with heart failure. Usual care is delivered according to local clinical practice and existing guidelines, without implementation of the Heart Failure Center Accreditation Program (HF-CAP) or additional quality improvement interventions.

Treatment:

Other: Usual Care