Energetic Abnormalities in Heart Failure With Preserved Ejection Fraction

February 24, 2008 updated by: University Hospital Birmingham
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

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

Study Contact

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B15 2TT
        • Recruiting
        • University of Birmingham
        • Contact:
        • Sub-Investigator:
          • Thanh T Phan, MRCP

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

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Heart Failure Clinic

Description

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

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

Cohorts and Interventions

Group / Cohort
HfpEF
Patients with Heart Failure with preserved ejection fraction
Control
Healthy Volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete echocardiographic assessment to assess resting diastolic function
Time Frame: 1 DAY
1 DAY
Assessment of resting large artery function
Time Frame: 1 DAY
1 DAY
Multiple Gated Acquisition Scan
Time Frame: 1 DAY
1 DAY
Cardiac Magnetic Resonance Spectroscopy
Time Frame: 1 DAY
1 DAY
Metabolic Exercise Testing (VO2max)
Time Frame: 1 DAY
1 DAY

Collaborators and Investigators

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

Sponsor

University Hospital Birmingham

Collaborators

British Heart Foundation
Heart of England NHS Trust

Investigators

  • Principal Investigator: Michael Frenneaux, FRCP, University of Birmingham

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

March 1, 2006

Primary Completion (Anticipated)

April 1, 2009

Study Completion (Anticipated)

April 1, 2009

Study Registration Dates

First Submitted

February 24, 2008

First Submitted That Met QC Criteria

February 24, 2008

First Posted (Estimate)

March 4, 2008

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

February 24, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RRK 2996

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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