Clinical trial NCT01030991: Classification of Heart Failure With Preserved Ejection Fraction
Official title: Etiologic, Pathophysiologic, and Genetic Classification of Heart Failure With Preserved Ejection Fraction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure With Preserved Ejection Fraction
Diastolic Heart Failure
Keywords: Heart failure
Ejection fraction
Diastolic heart failure
Diastolic dysfunction
Ventricular-arterial coupling
Exercise testing
Echocardiography
Tissue Doppler imaging
Arterial tonometry
Genetics
Epidemiology
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2009-12-14
Enrollment: 514
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility 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%

Primary outcomes:
measure: Heart failure hospitalization
timeFrame: 1 year
measure: Cardiovascular hospitalization
timeFrame: 1 year
measure: Mortality - all cause and cardiovascular
timeFrame: 1 year
Secondary outcomes:
measure: Exercise capacity (peak VO2)
timeFrame: 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Sanjiv J Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.