Energetic Abnormalities in Heart Failure With Preserved Ejection Fraction

This study is currently recruiting participants.

Verified by University Hospital Birmingham, February 2008

First Received: February 24, 2008 No Changes Posted

Sponsors and Collaborators:	University Hospital Birmingham Heart of England NHS Trust British Heart Foundation
Information provided by:	University Hospital Birmingham
ClinicalTrials.gov Identifier:	NCT00628082

Purpose

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.

Condition
Heart Failure, Diastolic

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort
Official Title:	Energetic Abnormalities in Heart Failure With Preserved Ejection Fraction

Further study details as provided by University Hospital Birmingham:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	50
Study Start Date:	March 2006
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
HfpEF Patients with Heart Failure with preserved ejection fraction
Control Healthy Volunteers

Eligibility

Ages Eligible for Study:	40 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Heart Failure Clinic

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628082

Contacts

Contact: Thanh T Phan, MRCP

01214145916

ttpquang@hotmail.com

Locations

United Kingdom
University of Birmingham	Recruiting
Birmingham, United Kingdom, B15 2TT
Contact: Thanh T Phan, MRCP 01214145916 ttpquang@hotmail.com
Sub-Investigator: Thanh T Phan, MRCP

Sponsors and Collaborators

University Hospital Birmingham

Heart of England NHS Trust

British Heart Foundation

Investigators

Principal Investigator:

Michael Frenneaux, FRCP

University of Birmingham

More Information

No publications provided

Responsible Party:	University of Birmingham ( Prof Michael Frenneaux )
Study ID Numbers:	RRK 2996
Study First Received:	February 24, 2008
Last Updated:	February 24, 2008
ClinicalTrials.gov Identifier:	NCT00628082 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by University Hospital Birmingham:

Cardiac Energetics
Dynamic Diastolic filling Assessment
Heart Failure with Preserved Ejection Fraction
Arterial and Ventricular Stiffening

Study placed in the following topic categories:

Heart Failure, Diastolic
Heart Failure
Heart Diseases
Congenital Abnormalities

Additional relevant MeSH terms:

Heart Failure, Diastolic
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009