Clinical Study of Active Intervention in High-risk HFpEF Patients

NCT06532019 | Not Yet Recruiting

• 1 other identifier: HFpEF intervention trial
• Study Type: interventional
• Target: 924
• Locations: 0 countries
• Sites: N/A

Brief Summary

Based on inclusion and exclusion criteria, this experiment plans to include 924 Heart Failure with Preserved Ejection Fraction(HFpEF) patients with increased risk of all-cause death. The enrolled patients will divided into usual care group (n=462) and targeted intervention group (n=462) in a 1:1 ratio. The usual care patients will receive routine heart failure treatment. Patients in targeted intervention group, on top of routine therapy for heart failure, will receive further therapy targeting therapy to correct hypoalbuminemia, anemia or hyponatremia, and try to enhance medication to lower N-terminal pro brain natriuretic peptide (NT-proBNP), C-reactive protein(CRP), New York Heart Association(NYHA )Classification, to add diuretics for patients with higher right ventricular diameters(RADs),multidiscipline intervention for patients complicating chronic obstructive pulmonary disease(COPD), and actively reperfusion for ischemic HFpEF patients. The incidence of all-cause death will be compared after 3 years follow-up.The primary endpoint is the occurrence of all-cause mortality events during the follow-up period.

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

all-cause mortality

Outcome Measures

Primary Outcomes (1)

• all-cause mortality

  follow-up by clinical visit, telephone call or community visit

  The patients will be followed up for 3 years after they were enrolled.

Study Arms (2)

usual care group

NO INTERVENTION

Patients in this group will receive usual medical care for heart failure.

targeted intervention group

EXPERIMENTAL

Patients in this group, besides usal medical care for heart failure, will receive targeted therapy: correct hypoalbuminemia, anemia or hyponatremia, and try to enhance medication to lower NT-proBNP, CRP, NYHA Classification, to add diuretics for patients with higher RADs, multidiscipline intervention for patients complicating COPD, and actively reperfusion for ischemic HFpEF patients.

Other: Targeted intervention based on risk factors

Interventions

Targeted intervention based on risk factors OTHER

Correct hypoalbuminemia, anemia or hyponatremia, and try to enhance medication to lower NT-proBNP, CRP, NYHA Classification, to add diuretics for patients with higher RADs, multidiscipline intervention for patients complicating COPD, and actively reperfusion for ischemic HFpEF patients.

targeted intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Discharged HFpEF patients with risk score \> or equal 200.37.

You may not qualify if:

• Patients with a life expectancy of less than 1-year due to malignancy.

Sponsors & Collaborators

• Xiangtan Central Hospital: lead
• The First People's Hospital of Xiangtan City: collaborator
• The Xiangtan People's Hospital: collaborator
• The Xiangxiang People's Hospital: collaborator

Study Officials

• Hong Xia, PH.D

  Xiangtan Central Hospital

  STUDY CHAIR

Central Study Contacts

Jianping Zeng, PH.D

CONTACT

073158214998; xhjiang2@hnust.edu.cn

Yunlong Zhu, PH.D

CONTACT

073158286303; zhuyunlong@hnu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean, Xiangtan Central Hospital ,Director of cardiovascular clinic, Clinical Professor

Study Record Dates

• First Submitted: July 27, 2024
• First Posted: August 1, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share