Cardioprotective and metabolic effects of metformin in patients with heart failure and diabetes

• Conditions: type 2 diabetes mellitus, heart failure; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2012-001390-88-CZ
• Lead Sponsor: Institute for Clinical and Experimental Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-28
• Last Update Posted: 10 March 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.chronic heart failure will be defined by the following criteria (all must be included):
?diagnosis of HF known for at least 6 months
?medical history of hospitalization for cardiac decompensation with need for parenteral therapy for congestion - X-ray findings or swelling of lower extremities
?stable drug therapy at least 1 month
?treatment with diuretics (thiazide or furosemide)
?LVEF below 50%
2.the presence of diabetes will be defined by:
?diagnosis and treatment of type 2 diabetes in the medical history
?screening blood sample:
¦the value of HbA1c(according to IFCC)= 4.8% + fasting glucose = 7.0 mmol / l in venous plasma or
¦the value of HbA1c = 4.8%(according to IFCC) + random blood glucose = 11.1 mmol/l in venous plasma
¦or OGTT - blood glucose level at 120 min = 11.1 mmol/l OGTT is indicated just in case of positivity of one of the criteria (fasting glucose + HbA1c or HbA1c + random blood glucose)
3.treatment of diabetes - by diet only
4.women and men aged 40-70 years
5.body mass index (kg/m2) in the range of 20-35
6.the range of HbA1c between 4-6,5% IFCC
7.signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1.the planned cardiac intervention during the study that affect the function of the heart (revascularization including PCI, heart surgery, implantation of pacemaker, RF ablation; urgent candidate for OTS
2.metabolic disease, including: 1 type diabetes, decompensated thyreopatii (Note: patients with hypothyroidism and stable substitution (the last 3 months) of normal TSH levels may participate in the study
3.treatment with insulin or PAD one month before the recruitment(patients who were temporarily treated with insulin during hospitalization may participate in the study)
4.pregnancy (positive ß-HCG test), breast feeding, trying to become pregnant
5.clinically significant anemia with hemoglobin below 100 g/l
6.pacemaker or metallic implant in the body (MRI)
7.renal insufficiency with eGF below 0.7 ml/s
8.atrial fibrillation - present during screening test
9.the presence of other medical condition, which occurs during physical examination, laboratory tests, ECG, including pulmonary, neurological or inflammatory disease, which would be considered by the examiner to distort the consistency of data

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified