Energetic Abnormalities in Heart Failure With Preserved Ejection Fraction - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 24, 2008

Last Updated Date

February 24, 2008

Start Date ^†

March 2006

Current Primary Outcome Measures ^†

Complete echocardiographic assessment to assess resting diastolic function [ Time Frame: 1 DAY ] [ Designated as safety issue: No ]
Assessment of resting large artery function [ Time Frame: 1 DAY ] [ Designated as safety issue: No ]
Multiple Gated Acquisition Scan [ Time Frame: 1 DAY ] [ Designated as safety issue: No ]
Cardiac Magnetic Resonance Spectroscopy [ Time Frame: 1 DAY ] [ Designated as safety issue: No ]
Metabolic Exercise Testing (VO2max) [ Time Frame: 1 DAY ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Energetic Abnormalities in Heart Failure With Preserved Ejection Fraction

Official Title ^†

Energetic Abnormalities in Heart Failure With Preserved Ejection Fraction

Brief Summary

Up to half of all patients with heart failure are found to have normal pumping function of the heart muscle, but show abnormalities in the way the heart muscle relaxes and fills with blood. These patients often have high blood pressure, and tend to have stiff arteries and stiff heart muscle. We wish to test the hypothesis that these patients have abnormal energy stores in their heart muscle.

Detailed Description

Study Phase

Study Type ^†

Observational

Study Design ^†

Cohort, Other

Condition ^†

Heart Failure, Diastolic

Intervention ^†

Study Arms / Comparison Groups

Patients with Heart Failure with preserved ejection fraction
Healthy Volunteers

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

Estimated Completion Date

April 2009

Estimated Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Clinical features consistent with heart failure
LVEF ≥ 50%, with no evidence of significant valvular disease, no hypertrophic cardiomyopathy, and no evidence of pericardial constriction
A peak VO2 < 80% predicted, with a pattern of gas exchange on metabolic exercise testing indicating a cardiac cause for limitation

Exclusion Criteria:

Objective evidence of lung disease on formal lung function testing
Reversible myocardial ischaemia on contrast-enhanced myocardial stress
Echocardiography, and evidence of exercise-induced mitral regurgitation
Obesity (BMI >35) or a locomotor cause for exercise limitation

Gender

Both

Ages

40 Years to 85 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Thanh T Phan, MRCP

01214145916

ttpquang@hotmail.com

Location Countries ^†

United Kingdom

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00628082

Responsible Party

Prof Michael Frenneaux, University of Birmingham

Secondary IDs ^††

Study Sponsor ^†

University Hospital Birmingham

Collaborators ^††

Heart of England NHS Trust
British Heart Foundation

Investigators ^†

Principal Investigator:

Michael Frenneaux, FRCP

University of Birmingham

Information Provided By

University Hospital Birmingham

Verification Date

February 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.