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Clinical Trials/NCT01030991
NCT01030991
Completed
Not Applicable

Etiologic, Pathophysiologic, and Genetic Classification of Heart Failure With Preserved Ejection Fraction

Northwestern University1 site in 1 country514 target enrollmentJuly 1, 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure With Preserved Ejection Fraction
Sponsor
Northwestern University
Enrollment
514
Locations
1
Primary Endpoint
Cardiovascular hospitalization
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2008
End Date
May 21, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sanjiv Shah

Associate Professor of Medicine

Northwestern University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Cardiovascular hospitalization

Time Frame: 1 year

Mortality - all cause and cardiovascular

Time Frame: 1 year

Heart failure hospitalization

Time Frame: 1 year

Secondary Outcomes

  • Exercise capacity (peak VO2)(1 year)

Study Sites (1)

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