We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Energetic Abnormalities in Heart Failure With Preserved Ejection Fraction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00628082
Recruitment Status : Unknown
Verified February 2008 by University Hospital Birmingham.
Recruitment status was:  Recruiting
First Posted : March 4, 2008
Last Update Posted : March 4, 2008
Information provided by:

Study Description
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.

Condition or disease
Heart Failure, Diastolic

Study Design

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Official Title: Energetic Abnormalities in Heart Failure With Preserved Ejection Fraction
Study Start Date : March 2006
Estimated Primary Completion Date : April 2009
Estimated Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Groups and Cohorts

Patients with Heart Failure with preserved ejection fraction
Healthy Volunteers

Outcome Measures

Primary Outcome Measures :
  1. Complete echocardiographic assessment to assess resting diastolic function [ Time Frame: 1 DAY ]
  2. Assessment of resting large artery function [ Time Frame: 1 DAY ]
  3. Multiple Gated Acquisition Scan [ Time Frame: 1 DAY ]
  4. Cardiac Magnetic Resonance Spectroscopy [ Time Frame: 1 DAY ]
  5. Metabolic Exercise Testing (VO2max) [ Time Frame: 1 DAY ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Heart Failure Clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00628082

Contact: Thanh T Phan, MRCP 01214145916 ttpquang@hotmail.com

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
Principal Investigator: Michael Frenneaux, FRCP University of Birmingham
More Information

Responsible Party: Prof Michael Frenneaux, University of Birmingham
ClinicalTrials.gov Identifier: NCT00628082     History of Changes
Other Study ID Numbers: RRK 2996
First Posted: March 4, 2008    Key Record Dates
Last Update Posted: March 4, 2008
Last Verified: February 2008

Keywords provided by University Hospital Birmingham:
Cardiac Energetics
Dynamic Diastolic filling Assessment
Heart Failure with Preserved Ejection Fraction
Arterial and Ventricular Stiffening

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases