Classification of Heart Failure With Preserved Ejection Fraction - Full Text View

Sponsor:	Northwestern University
Information provided by:	Northwestern University
ClinicalTrials.gov Identifier:	NCT01030991

Purpose

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

Condition
Heart Failure With Preserved Ejection Fraction Diastolic Heart Failure

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Etiologic, Pathophysiologic, and Genetic Classification of Heart Failure With Preserved Ejection Fraction

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Exercise and Physical Fitness Heart Failure

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:

Heart failure hospitalization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Cardiovascular hospitalization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Mortality - all cause and cardiovascular [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Exercise capacity (peak VO2) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Whole blood, saliva

Estimated Enrollment:	1000
Study Start Date:	July 2008
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
HFpEF HFpEF cohort (observational study)

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. 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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

All patients with signs or symptoms of heart failure with left ventricular ejection fraction > 50% are eligible for the study

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%

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01030991

Contacts

Contact: Sofia Podlusky	312-503-1824	s-podlusky@northwestern.edu
Contact: Sanjiv J Shah, MD	312-926-2926	sanjiv.shah@northwestern.edu

Locations

United States, Illinois
Northwestern University Feinberg School of Medicine	Recruiting
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Investigators

Principal Investigator:

Sanjiv J Shah, MD

Northwestern University Feinberg School of Medicine

More Information

Additional Information:

Northwestern University Heart Failure with Preserved Ejection Fraction (HFpEF) Program This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sanjiv Shah, MD; Assistant Professor of Medicine; Director, Heart Failure with Preserved Ejection Fraction, Northwestern University Feinberg School of Medicine
ClinicalTrials.gov Identifier:	NCT01030991 History of Changes
Other Study ID Numbers:	AHA 0835488N
Study First Received:	December 10, 2009
Last Updated:	April 19, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Northwestern University:

Heart failure
Ejection fraction
Diastolic heart failure
Diastolic dysfunction
Ventricular-arterial coupling
Exercise testing

Echocardiography
Tissue Doppler imaging
Arterial tonometry
Genetics
Epidemiology

Additional relevant MeSH terms:

Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012