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Classification of Heart Failure With Preserved Ejection Fraction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Northwestern University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Sanjiv Shah, Northwestern University
ClinicalTrials.gov Identifier:
NCT01030991
First received: December 10, 2009
Last updated: June 28, 2012
Last verified: June 2012
  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:


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 2013
Estimated Primary Completion Date: June 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: Sanjiv Shah, Assistant Professor of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT01030991     History of Changes
Other Study ID Numbers: AHA 0835488N
Study First Received: December 10, 2009
Last Updated: June 28, 2012
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
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 20, 2014