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

Official title

Heart Failure Center Accreditation Program (HF-CAP) in China: A Prospective Multicenter Cluster Randomized Controlled Trial

Overview

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.

Interventions

• Other Heart Failure Center Accreditation Program (HF-CAP)
  The Heart Failure Center Accreditation Program (HF-CAP) is a hospital-level quality improvement intervention that includes standardized heart failure care processes, multidisciplinary team-based management, professional training, patient and caregiver education, structured discharge planning, post-discharge follow-up, and continuous performance monitoring and feedback.
• Other Usual Care
  Usual care refers to the routine clinical management of patients hospitalized with heart failure according to local clinical practice and existing guidelines at each participating hospital. Hospitals assigned to this group do not implement the Heart Failure Center Accreditation Program (HF-CAP) or any additional structured quality improvement interventions beyond usual practice.

Primary outcome measures

• Composite of Heart Failure Rehospitalization or All-Cause Mortality [Time frame: Within 12 months after hospital discharge]
• Heart Failure Management Quality Score [Time frame: From baseline hospitalization to 12 months after discharge]

Secondary outcome measures (4)

• Time to First Heart Failure Rehospitalization [Time frame: Within 12 months after hospital discharge]
• Number of Heart Failure Rehospitalizations [Time frame: Within 12 months after hospital discharge]
• All-Cause Rehospitalization [Time frame: Within 12 months after hospital discharge]
• All-Cause Mortality [Time frame: Within 12 months after hospital discharge]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07371780 · B2025 -675

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗