NCT01030991

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
514

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 14, 2009

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2019

Completed
Last Updated

May 23, 2019

Status Verified

May 1, 2019

Enrollment Period

10.9 years

First QC Date

December 10, 2009

Last Update Submit

May 21, 2019

Conditions

Heart Failure With Preserved Ejection FractionDiastolic Heart Failure

Keywords

Heart failureEjection fractionDiastolic heart failureDiastolic dysfunctionVentricular-arterial couplingExercise testingEchocardiographyTissue Doppler imagingArterial tonometryGeneticsEpidemiology

Outcome Measures

Primary Outcomes (3)

  • Heart failure hospitalization

    1 year

  • Cardiovascular hospitalization

    1 year

  • Mortality - all cause and cardiovascular

    1 year

Secondary Outcomes (1)

  • Exercise capacity (peak VO2)

    1 year

Study Arms (1)

HFpEF

HFpEF cohort (observational study)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with signs or symptoms of heart failure with left ventricular ejection fraction \> 50% are eligible for the study

You may qualify if:

  • Age \> 21 years
  • Signs or symptoms of congestive heart failure
  • Left ventricular ejection fraction \> 50%

You may not qualify if:

  • Severe valvular heart disease
  • History of cardiac transplantation
  • Prior history of heart failure associated with left ventricular ejection fraction \< 35%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (5)

  • 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.

    PMID: 25398313RESULT

  • 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.

    PMID: 30371285DERIVED

  • 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.

    PMID: 26941415DERIVED

  • 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.

    PMID: 26635076DERIVED

  • 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.

    PMID: 25282032DERIVED

Related Links

Biospecimen

Retention: NONE RETAINED

Whole blood, saliva

MeSH Terms

Conditions

Heart Failure, DiastolicHeart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Sanjiv J Shah, MD

    Northwestern University Feinberg School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

December 10, 2009

First Posted

December 14, 2009

Study Start

July 1, 2008

Primary Completion

May 21, 2019

Study Completion

May 21, 2019

Last Updated

May 23, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)