se of aldosterone blockade to improve cardiac function in obesity

Phase 4

• Conditions: Diastolic Dysfunction; Myocardial fibrosis; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12609000655246
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Obesity: Body mass index (BMI) > 30

Exclusion Criteria

Diabetes, cardiovascular disease or other chronic disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Myocardial fibrosis.<br>Cardiac Magnetic Resonance Imaging (MRI) will be performed on a 1.5 Tesla GE Signa scanner using Electrocardiography (ECG) gating, dedicated cardiac coils, and commercially available software. Initial localiser sequences are followed by b-SSFP cine sequences in the vertical long axis, horizontal long axis, and left ventricular short axis. A comprehensive functional study will be performed followed by myocardial characterisation with T1 and T2 weighted imaging, quantification of T2*. Following this resting myocardial perfusion will be assessed following administration of intravenous contrast (containing Gadolinium), then delayed contrast enhanced MRI will be performed to assess fibrosis.[Baseline and post intervetion (26 weeks)]

Secondary Outcome Measures

Name	Time	Method
Diastolic function.<br>A resting echo will be performed using a commercially available Vivid 7. A variable-frequency phased array transducer will be used for all two-dimensional, M-mode and Doppler examinations. Tissue Doppler/strain: Color myocardial tissue Doppler will be obtained with frame-rates set at >110 frames/sec, with a pulse repetition frequency between 500Hz to 1KHz, resulting in aliasing velocity >16 cm/sec. Digital storage of three sequential cardiac cycle loops triggered to the QRS complex will be saved to magneto-optical disk for off-line analysis of backscatter and strain.[Baseline and post intervetion (26 weeks)];Biochemistry.<br>Collagen biomarkers (PICP, PINP, PIIINP) will be measured by immunoassay as surrogate measures of myocardial fibrosis.[Baseline and post intervetion (26 weeks)]