NCT00628082

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 4, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

March 4, 2008

Status Verified

February 1, 2008

Enrollment Period

3.1 years

First QC Date

February 24, 2008

Last Update Submit

February 24, 2008

Conditions

Heart Failure, Diastolic

Keywords

Cardiac EnergeticsDynamic Diastolic filling AssessmentHeart Failure with Preserved Ejection FractionArterial and Ventricular Stiffening

Outcome Measures

Primary Outcomes (5)

  • Complete echocardiographic assessment to assess resting diastolic function

    1 DAY

  • Assessment of resting large artery function

    1 DAY

  • Multiple Gated Acquisition Scan

    1 DAY

  • Cardiac Magnetic Resonance Spectroscopy

    1 DAY

  • Metabolic Exercise Testing (VO2max)

    1 DAY

Study Arms (2)

HfpEF

Patients with Heart Failure with preserved ejection fraction

Control

Healthy Volunteers

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Heart Failure Clinic

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Birmingham

Birmingham, B15 2TT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular Diseases

Study Officials

  • Michael Frenneaux, FRCP

    University of Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thanh T Phan, MRCP

CONTACT

01214145916ttpquang@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 24, 2008

First Posted

March 4, 2008

Study Start

March 1, 2006

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

March 4, 2008

Record last verified: 2008-02

Locations

GB(1)