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NCT Number: NCT06532019

Clinical Study of Active Intervention in High-risk HFpEF Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Our newly finished study developed and validated a risk prediction model for all-cause mortality in patients with HFpEF based on real-world data. The nomogram prediction model included factors such as NT-proBNP, albumin, age, NYHA class III-IV, CRP, RADs, hemoglobin, COPD, hyponatremia, and Percutaneous Coronary Intervention(PCI). Discharged HFpEF patients with scores ≥200.37 were found to be associated with increased risk of all-cause death up to 3 years. In this trial, we sought to evaluate the impact of targeted risk factors intervention post-discharge in patients with with scores ≥200.37 on all-cause death up to 3 years.

Based on inclusion and exclusion criteria,We will enroll 924 patients with HFpEF and scores ≥200.37. The enrolled patients will divided into a usual care group (n=462) and targeted intervention group (n=462) in a 1:1 ratio. The usual care group 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 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. The primary endpoint is the occurrence of all-cause mortality events during the 3 years follow-up period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. all-cause mortality

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jianping Zeng, PH.D

CONTACT

[email protected]

073158214998

Yunlong Zhu, PH.D

CONTACT

[email protected]

073158286303

Sponsors and collaborators

Lead sponsor

Xiangtan Central Hospital

Other

Collaborators

  • The First People's Hospital of Xiangtan City
  • The Xiangtan People's Hospital
  • The Xiangxiang People's Hospital

Registry information

Official study title

Randomized Multicenter Clinical Trial in Heart Failure Patients With Preserved Ejection Fraction (HFpEF) at Intermediate and High Risk of All-cause Death

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Aug 1, 2024
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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