Energetic Abnormalities in Heart Failure With Preserved Ejection Fraction

Heart Failure, Diastolic Clinical Trial

Official title:

Energetic Abnormalities in Heart Failure With Preserved Ejection Fraction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00628082
• Other study ID #: RRK 2996
• Status: Recruiting
• Phase: N/A
• First received: February 24, 2008
• Last updated: February 24, 2008
• Start date: March 2006
• Est. completion date: April 2009

Study information

• Verified date: February 2008
• Source: University Hospital Birmingham
• Contact: Thanh T Phan, MRCP
• Phone: 01214145916
• Email: ttpquang[@]hotmail.com
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Diastolic

Locations

Country	Name	City	State
United Kingdom	University of Birmingham	Birmingham

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Birmingham	British Heart Foundation, Heart of England NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete echocardiographic assessment to assess resting diastolic function		1 DAY	No
Primary	Assessment of resting large artery function		1 DAY	No
Primary	Multiple Gated Acquisition Scan		1 DAY	No
Primary	Cardiac Magnetic Resonance Spectroscopy		1 DAY	No
Primary	Metabolic Exercise Testing (VO2max)		1 DAY	No