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Completed

NCT Number: NCT01030991

Classification of Heart Failure With Preserved Ejection Fraction

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

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Key information

Conditions

Heart Failure With Preserved Ejection Fraction Cardiovascular Diseases Diastolic Heart Failure Heart Diseases Heart Failure Heart Failure, Diastolic

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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%

Treatment and study plan

Primary outcomes

  1. Heart failure hospitalization

    Time frame: 1 year

  2. Cardiovascular hospitalization

    Time frame: 1 year

  3. Mortality - all cause and cardiovascular

    Time frame: 1 year

Secondary outcomes

  1. Exercise capacity (peak VO2)

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2019
Study completion
2019
First posted
Dec 14, 2009
Registry last updated
May 23, 2019

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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