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Classification of Heart Failure With Preserved Ejection Fraction

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ClinicalTrials.gov Identifier: NCT01030991
Recruitment Status : Recruiting
First Posted : December 14, 2009
Last Update Posted : May 3, 2016
Sponsor:
Information provided by (Responsible Party):
Sanjiv Shah, Northwestern University

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).

Condition or disease
Heart Failure With Preserved Ejection Fraction Diastolic Heart Failure

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.

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Etiologic, Pathophysiologic, and Genetic Classification of Heart Failure With Preserved Ejection Fraction
Study Start Date : July 2008
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Group/Cohort
HFpEF
HFpEF cohort (observational study)



Primary Outcome Measures :
  1. Heart failure hospitalization [ Time Frame: 1 year ]
  2. Cardiovascular hospitalization [ Time Frame: 1 year ]
  3. Mortality - all cause and cardiovascular [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Exercise capacity (peak VO2) [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Whole blood, saliva


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01030991


Contacts
Contact: Sanjiv 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanjiv Shah, Associate Professor of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT01030991     History of Changes
Other Study ID Numbers: AHA 0835488N
First Posted: December 14, 2009    Key Record Dates
Last Update Posted: May 3, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sanjiv Shah, Northwestern University:
Heart failure
Diastolic heart failure
Ejection fraction
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