Text Size

Energetic Abnormalities in Heart Failure With Preserved Ejection Fraction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by University Hospital Birmingham.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Heart of England NHS Trust
British Heart Foundation
Information provided by:
University Hospital Birmingham
ClinicalTrials.gov Identifier:
NCT00628082
First received: February 24, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted
  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

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

Resource links provided by NLM:

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

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 ]

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: Prof Michael Frenneaux, University of Birmingham
ClinicalTrials.gov Identifier: NCT00628082     History of Changes
Other Study ID Numbers: RRK 2996
Study First Received: February 24, 2008
Last Updated: February 24, 2008
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

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

ClinicalTrials.gov processed this record on May 23, 2013