Classification of Heart Failure With Preserved Ejection Fraction

NCT ID: NCT01030991

Last Updated: 2019-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

514 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-01

Study Completion Date

2019-05-21

Brief Summary

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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

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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.

Conditions

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Heart Failure With Preserved Ejection Fraction Diastolic Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HFpEF

HFpEF cohort (observational study)

No interventions assigned to this group

Eligibility Criteria

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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%
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Sanjiv Shah

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sanjiv J Shah, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Feinberg School of Medicine

Locations

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Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.114.010637. Epub 2014 Nov 14.

Reference Type RESULT
PMID: 25398313 (View on PubMed)

Rich JD, Burns J, Freed BH, Maurer MS, Burkhoff D, Shah SJ. Meta-Analysis Global Group in Chronic (MAGGIC) Heart Failure Risk Score: Validation of a Simple Tool for the Prediction of Morbidity and Mortality in Heart Failure With Preserved Ejection Fraction. J Am Heart Assoc. 2018 Oct 16;7(20):e009594. doi: 10.1161/JAHA.118.009594.

Reference Type DERIVED
PMID: 30371285 (View on PubMed)

Freed BH, Daruwalla V, Cheng JY, Aguilar FG, Beussink L, Choi A, Klein DA, Dixon D, Baldridge A, Rasmussen-Torvik LJ, Maganti K, Shah SJ. Prognostic Utility and Clinical Significance of Cardiac Mechanics in Heart Failure With Preserved Ejection Fraction: Importance of Left Atrial Strain. Circ Cardiovasc Imaging. 2016 Mar;9(3):10.1161/CIRCIMAGING.115.003754 e003754. doi: 10.1161/CIRCIMAGING.115.003754.

Reference Type DERIVED
PMID: 26941415 (View on PubMed)

Unger ED, Dubin RF, Deo R, Daruwalla V, Friedman JL, Medina C, Beussink L, Freed BH, Shah SJ. Association of chronic kidney disease with abnormal cardiac mechanics and adverse outcomes in patients with heart failure and preserved ejection fraction. Eur J Heart Fail. 2016 Jan;18(1):103-12. doi: 10.1002/ejhf.445. Epub 2015 Dec 3.

Reference Type DERIVED
PMID: 26635076 (View on PubMed)

Katz DH, Burns JA, Aguilar FG, Beussink L, Shah SJ. Albuminuria is independently associated with cardiac remodeling, abnormal right and left ventricular function, and worse outcomes in heart failure with preserved ejection fraction. JACC Heart Fail. 2014 Dec;2(6):586-96. doi: 10.1016/j.jchf.2014.05.016. Epub 2014 Oct 1.

Reference Type DERIVED
PMID: 25282032 (View on PubMed)

Related Links

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http://www.hfpef.org

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

Other Identifiers

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AHA 0835488N

Identifier Type: -

Identifier Source: org_study_id

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