Potential therapy for left ventricular hypertrophy in diabetic heart disease

Phase 2

Completed

• Conditions: eft-ventricular hypertrophy in type-2 diabetic patients; Left-ventricular hypertrophy in type-2 diabetic patients; Metabolic and Endocrine - Diabetes; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12609000053224
• Lead Sponsor: Protemix Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Age between 30 and 70 years; known type 2 diabetes; HbA1c > 7.0% at enrollment; normal electrocardiogram; abnormal diastolic filling as demonstrated by mitral inflow Doppler with pre-load reduction LV ejection fraction = 45% by echocardiography, with evidence of diastolic dysfunction but no regional wall-motion abnormalities; no new medications for six months prior to randomization with no change of ß-blocker dose during that period.

Exclusion Criteria

Morbid obesity (BMI = 45 kg.m-2); type 1 diabetes; history or evidence of diabetic retinopathy and/or diabetic nephropathy (serum creatinine > 150 µmol/l and/or urinary albumin > 300 mg/l); autonomic neuropathy; significant cardiac valvular disease; LV wall motion abnormality by echocardiography; history of significant malabsorption; multiple drug allergies; use or misuse of substances of abuse; evidence of abnormal electrolyte homeostasis or renal, hepatic or thyroid function; or standard contraindications to MRI

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
left ventricle mass indexed to body surface area (LVMbsa) after six and 12 months of therapy as determined by cardiac<br>magnetic resonance imaging (cMRI).[at baseline and at 6, 12 months after randomisation];Change in early mitral annular velocity (Em) as determined by echocardiography (ECHO)[at baseline and at 6 months after randomisation];Change in LV apical rotation at 140% of systole as determined by cMRI[at baseline and at 6, 12 months after randomisation]

Secondary Outcome Measures

Name	Time	Method
Change in urinary copper excretion[after four months]