Classification of Heart Failure With Preserved Ejection Fraction

Heart Failure With Preserved Ejection Fraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01030991
• Other study ID #: AHA 0835488N
• Status: Completed
• Start date: July 1, 2008
• Est. completion date: May 21, 2019

Study information

• Verified date: May 2019
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 514
• Est. completion date: May 21, 2019
• Est. primary completion date: May 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Diastolic Heart Failure
• Heart Failure
• Heart Failure With Preserved Ejection Fraction
• Heart Failure, Diastolic

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Shah SJ, Katz DH, Selvaraj S, Burke MA, Yancy CW, Gheorghiade M, Bonow RO, Huang CC, Deo RC. Phenomapping for novel classification of heart failure with preserved ejection fraction. Circulation. 2015 Jan 20;131(3):269-79. doi: 10.1161/CIRCULATIONAHA.114.0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart failure hospitalization		1 year
Primary	Cardiovascular hospitalization		1 year
Primary	Mortality - all cause and cardiovascular		1 year
Secondary	Exercise capacity (peak VO2)		1 year

External Links

•   Northwestern University Heart Failure with Preserved Ejection Fraction (HFpEF) Program