Classification of Heart Failure With Preserved Ejection Fraction
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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 |
All patients with signs or symptoms of heart failure with left ventricular ejection fraction > 50% are eligible for the study
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| Contact: Sanjiv Shah, MD | 312-926-2926 | sanjiv.shah@northwestern.edu |
| United States, Illinois | |
| Northwestern University Feinberg School of Medicine | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| 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 Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013