An interventional study of Heart Failure Center Accreditation Program (HF-CAP) and Usual Care in Heart Failure, sponsored by Shanghai Zhongshan Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Health services research
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 6,240 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.
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Eligibility Criteria for Participating Centers
Eligibility Criteria for Participants
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:
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.
Other: Heart Failure Center Accreditation Program (HF-CAP)
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.
Other: Usual Care
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.
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.
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
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
No study locations are listed for this record.
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This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Shanghai Zhongshan Hospital