Risk Factors In Heart Failure Patients With Preserved Ejection Fraction (RIPE-HF)

A Study on Risk Factors in Heart Failure Patients With Preserved Ejection Fraction After Hospital Discharge

This study aimed to identify the independent risk factors associated with heart failure readmission, cardiac mortality and all-cause death among patients discharged from Xiangtan Central Hospital with heart failure and preserved ejection fraction (HFpEF). Understanding related risk factors might add future clinical decision making for individualized post discharge management of HFpEF patients aiming to improve the outcome of discharged HFpEF patients.

Study Overview

• Status: Completed
• Conditions: Heart Failure With Preserved Ejection Fraction

Detailed Description

This study sought to determine the independent risk factors linked to endpoint events (which include all-cause mortality or readmission for heart failure, cardiovascular death) among hospitalized patients with heart failure and preserved ejection fraction (HFpEF) at Xiangtan Central Hospital during the period from May 1, 2014, to January 31, 2023. The clinical follow up ended on January 31, 2024. The study examined the risk factors associated with the endpoint outcome (cardiovascular death and death from any cause and readmission due to heart failure) to provide clinical evidence for intervening discharged HFpEF patients, with the objective of improving patient outcomes in future clinical practice.

The clinical features of hospitalized heart failure with preserved ejection fraction (HFpEF, EF≥50%) are analyzed retrospectively by reviewing the patient's demographic, clinical data, including patient medical history, initial clinical evaluations, and therapeutic interventions, as well as echocardiographic data in the hospital's electronic health records and relevant databases. The clinical outcome of enrolled patients are obtained through a team of three experienced cardiologists and twelve nursing professionals through outpatient consultations, telephone follow-ups, and community visit. The primary endpoint events are all-cause mortality, the second endpoints are the composite cardiovascular death and heart failure readmission.

• Study Type: Observational
• Enrollment (Actual): 9419

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients who hospitalized the Xiangtan Central Hospital between May 1, 2014, and January 31, 2023, with the diagnosis of heart failure and met HFpEF criteria at final analysis.

Description

Inclusion Criteria:

• Patients discharged with diagnosis of heart failure were screened and met definition of heart failure with preserved ejection fraction (HFpEF) according to the 2021 European Society of Cardiology (ESC) guidelines at final analysis.
• 1）Heart failure signs and symptoms; 2）LVEF>50%;

Exclusion Criteria:

• 1) age under 18 years; 2) life expectancy of less than one year due to non-cardiac conditions.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
HFpEF Group; HFpEF (Heart failure with preserved ejection fraction): LVEF≥50%. Non-endpoint events group versus Endpoint events (all-cause death,cardiovascular death or heart failure readmission) group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death（people）	Risk factors of all-cause death are analyzed（Increase the factors that contribute to the occurrence of endpoint events）	The patients are clinically followed up until January 31, 2024, per clinical visit or telephone call or community visit.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular death and Heart failure readmission（people）	The risk factors related to cardiovascular death and heart failure readmission post discharge are analyzed.（Increase the factors that contribute to the occurrence of endpoint events）	The patients are clinically followed up until January 31, 2024, per clinical visit or telephone call or community visit.

Collaborators and Investigators

• Sponsor: Xiangtan Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: HFpEF, Outcome
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2024/6

Drug and device information, study documents

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