Potential therapy for left ventricular hypertrophy in diabetic heart disease

Pilot study of the effects on cardiac diastolic function of GC811007, a fructosamine oxidase inhibitor, in patients with Type 2 diabetes and diabetic cardiomyopathy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000053224

Acronym

INFO-CARDIAC

Enrollment

Registered

2009-01-23

Start date

2001-03-14

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study was designed to assess the effects of the drug triethylenetetramine dihydrochloride on cardiac dysfunction in patients with type 2 diabetes (T2DM) and demonstrable cardiac dysfunction. Previous treatment of diabetic rats has shown significant improvement in structure and function of the heart, including alleviation of heart failure through significant cardiac regeneration, and clinical studies have shown that TETA.2HCl may work through chelation and excretion of copper (Cu) in urine. This study was designed to measure indices of cardiac structure over a 12 month intervention period and hypothesized that markers of diastolic dysfunction in T2DM would be improved on treatment versus placebo.

Interventions

Oral administration of trientine[Triethylenetetramine dihydrochloride] 600 mg twice daily p.o. (two 300 mg capsules twice daily) before breakfast and evening meal. Duration period: 12 months.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

30 Years to 70 Years

Healthy volunteers

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

Outcome results