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Classification of Heart Failure With Preserved Ejection Fraction

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01030991
Enrollment
514
Registered
2009-12-14
Start date
2008-07-01
Completion date
2019-05-21
Last updated
2019-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diastolic Heart Failure, Heart Failure With Preserved Ejection Fraction

Keywords

Heart failure, Ejection fraction, Diastolic heart failure, Diastolic dysfunction, Ventricular-arterial coupling, Exercise testing, Echocardiography, Tissue Doppler imaging, Arterial tonometry, Genetics, Epidemiology

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.

Interventions

None listed

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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%

Design outcomes

Primary

MeasureTime frame
Heart failure hospitalization1 year
Cardiovascular hospitalization1 year
Mortality - all cause and cardiovascular1 year

Secondary

MeasureTime frame
Exercise capacity (peak VO2)1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026