Classification of Heart Failure With Preserved Ejection Fraction

Completed

• Conditions: Diastolic Heart Failure; Heart Failure With Preserved Ejection Fraction

• Registration Number: NCT01030991
• Lead Sponsor: Northwestern University

Brief Summary

The purpose of this study is to create a classification system for the heterogenous disorder of heart failure with preserved ejection fraction (HFpEF).

Detailed Description

Patients with HFpEF are a heterogeneous group with varying etiology and pathophysiology, which may play a large role in the difficulty in managing these patients and enrolling them in clinical trials. A major advance in the care of patients with HFpEF would be a classification system based on etiology, pathophysiology, and/or genetic factors as well as machine learning analyses. The ultimate goal of this study is to demonstrate that it is possible to better classify patients with HFpEF based on etiologic, pathophysiologic, and genetic differences between patients. If successful, this study could lead to: (1) novel risk estimation in patients with HFpEF and (2) more fruitful clinical trials based on targeting specific subsets of HFpEF.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-07-01
• Study First Submitted: 2009-12-10
• Study First Submitted QC: 2009-12-10
• Study First Posted: 2009-12-14
• Status Verified: 2019-05
• Primary Completion: 2019-05-21
• Study Completion: 2019-05-21
• Last Update Submitted: 2019-05-21
• Last Update Posted: 2019-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 514

Inclusion Criteria

• Age > 21 years
• Signs or symptoms of congestive heart failure
• Left ventricular ejection fraction > 50%

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Exclusion Criteria

• Severe valvular heart disease
• History of cardiac transplantation
• Prior history of heart failure associated with left ventricular ejection fraction < 35%

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiovascular hospitalization	1 year
Mortality - all cause and cardiovascular	1 year
Heart failure hospitalization	1 year

Secondary Outcome Measures

Name	Time	Method
Exercise capacity (peak VO2)	1 year

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States