Heart FailureNCT07371780
Heart Failure Center Accreditation in China (HF-CAP Trial)
A study testing Heart Failure Center Accreditation Program (HF-CAP) in people with Heart Failure, run by Shanghai Zhongshan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Heart Failure Center Accreditation Program (HF-CAP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,240 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
Who cannot join
- 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.
About this study
Official title: Heart Failure Center Accreditation Program (HF-CAP) in China: A Prospective Multicenter Cluster Randomized Controlled Trial
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.
Read more
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
- Being tested
- Heart Failure Center Accreditation Program (HF-CAP), Usual Care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Failure Center Accreditation Program (HF-CAP)Other
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| HF-CAP Intervention | Experimental | 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. Receives: Other: Heart Failure Center Accreditation Program (HF-CAP) |
| Usual Care | Active comparator | 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Heart Failure Rehospitalization or All-Cause Mortality
Measured: Within 12 months after hospital discharge
Heart Failure Management Quality Score
Measured: From baseline hospitalization to 12 months after discharge
Secondary outcomes (4)
Time to First Heart Failure Rehospitalization
Measured: Within 12 months after hospital discharge
Number of Heart Failure Rehospitalizations
Measured: Within 12 months after hospital discharge
All-Cause Rehospitalization
Measured: Within 12 months after hospital discharge
All-Cause Mortality
Measured: Within 12 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371780
- Sponsor's protocol ID
- B2025 -675
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure Center Accreditation Program (HF-CAP) in China: A Prospective Multicenter Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07371780
- Acronym / sponsor ID
- B2025 -675
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6,240 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HF-CAP Intervention | Experimental | Other: Heart Failure Center Accreditation Program (HF-CAP)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. |
| Usual Care | Active comparator | Other: Usual CareHospitals 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | HF-CAP Intervention |
| Usual CareUsual 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. | Other | Usual Care |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Heart Failure Center Accreditation Program (HF-CAP) in people with Heart Failure, run by Shanghai Zhongshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of Heart Failure Rehospitalization or All-Cause Mortality (time frame: Within 12 months after hospital discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.