Study of the Prognosis of Patients With Heart Failure With Preserved Ejection Fraction

Heart Failure With Preserved Ejection Fraction Clinical Trial

Official title:

Study of the Prognosis of Patients With Heart Failure With Preserved Ejection Fraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05496439
• Other study ID #: 2022-08
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: July 6, 2022

Study information

• Verified date: August 2022
• Source: Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Study of the prognosis of patients with heart failure with preserved ejection fraction

Description:

Obesity is an independent risk factor for heart failure with preserved ejection fraction (HFpEF), however, the impact of visceral fat area (VFA) in patients with HFpEF is unclear. According to established process of patients' selection, a total of 172 patients whose mean age was 72 years were included in this study, and the median follow-up duration was 395.5 days(interquartile range: 207.5 to 535.5 days). All patients were divided into two groups based on the best cut-off value of VFA, and the primary outcome of this study was all-cause death in patients with HFpEF. The aim of this study was to clarify whether VFA has prognostic value in patients with HFpEF by Kaplan-Meier analysis and cox analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: July 6, 2022
• Est. primary completion date: May 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult aged >=18years old;

2. Diagnosed with HFpEF.Diagnostic criteria including:

1)left ventricular ejection fraction =50%; 2)with the symptoms and/or signs of heart failure; 3)BNP=35 pg/mL and/or NTproBNP=125 pg/mL; 4)at least one additional criterion: relevant structural heart disease(LVH and/or LAE) or diastolic dysfunction

Exclusion Criteria:

1. Age <18 years old;

2. LVEF less than 45% at any time;

3. cancer diagnosis.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death	all-cause death	The median follow-up time of 395.5 days(interquartile range: 207.5 to 535.5 days)