Clinical Study of Active Intervention in High-risk HFpEF Patients

NCT06532019 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 924

Last updated 2024-08-01

No results posted yet for this study

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

Interventions

OTHER

Targeted intervention based on risk factors

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.

Sponsors & Collaborators

  • The First People's Hospital of Xiangtan City

    collaborator UNKNOWN
  • The Xiangtan People's Hospital

    collaborator UNKNOWN
  • The Xiangxiang People's Hospital

    collaborator UNKNOWN
  • Xiangtan Central Hospital

    lead OTHER

Principal Investigators

  • Hong Xia, PH.D · Xiangtan Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2027-08-01
Completion
2028-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06532019 on ClinicalTrials.gov