Clinical Study of Active Intervention in High-risk HFpEF Patients

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure With Preserved Ejection Fraction
• Intervention / Treatment: Other: Targeted intervention based on risk factors

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 924
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianping Zeng, PH.D; Phone Number: 073158214998; Email: xhjiang2@hnust.edu.cn
• Study Contact Backup: Name: Yunlong Zhu, PH.D; Phone Number: 073158286303; Email: zhuyunlong@hnu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: usual care group; Patients in this group will receive usual medical care for heart failure.
Experimental: targeted intervention group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Xiangtan Central Hospital
• Collaborators: The First People's Hospital of Xiangtan City; The Xiangtan People's Hospital; The Xiangxiang People's Hospital
• Investigators: Study Chair: Hong Xia, PH.D, Xiangtan Central Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: July 27, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: all-cause mortality
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: HFpEF intervention trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No