NCT07371780

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6,240 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2026-01-28
• Last updated: 2026-01-28