Classification of Heart Failure With Preserved Ejection Fraction

May 21, 2019 updated by: Sanjiv Shah, Northwestern University

Etiologic, Pathophysiologic, and Genetic Classification of Heart Failure With Preserved Ejection Fraction

The purpose of this study is to create a classification system for the heterogenous disorder of heart failure with preserved ejection fraction (HFpEF).

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

514

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
HFpEF
HFpEF cohort (observational study)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Heart failure hospitalization
Time Frame: 1 year
1 year
Cardiovascular hospitalization
Time Frame: 1 year
1 year
Mortality - all cause and cardiovascular
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Exercise capacity (peak VO2)
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Sanjiv J Shah, MD, Northwestern University Feinberg School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2008

Primary Completion (Actual)

May 21, 2019

Study Completion (Actual)

May 21, 2019

Study Registration Dates

First Submitted

December 10, 2009

First Submitted That Met QC Criteria

December 10, 2009

First Posted (Estimate)

December 14, 2009

Study Record Updates

Last Update Posted (Actual)

May 23, 2019

Last Update Submitted That Met QC Criteria

May 21, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHA 0835488N

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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