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OpenTrials
Completed

NCT Number: NCT06487468

Risk Factors In Heart Failure Patients With Preserved Ejection Fraction

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. All-cause death(people)

    Time frame: The patients are clinically followed up until January 31, 2024, per clinical visit or telephone call or community visit.

    Risk factors of all-cause death are analyzed(Increase the factors that contribute to the occurrence of endpoint events)

Secondary outcomes

  1. Cardiovascular death and Heart failure readmission(people)

    Time frame: The patients are clinically followed up until January 31, 2024, per clinical visit or telephone call or community visit.

    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)

Sponsors and collaborators

Lead sponsor

Xiangtan Central Hospital

Other

Registry information

Official study title

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

Acronym: RIPE-HF

Important dates

Study start
2014
Primary completion
2023
Study completion
2024
First posted
Jul 5, 2024
Registry last updated
Jul 8, 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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