Asymptomatic left ventricular diastolic dysfunction in diabetes MedDRA version: 17.0 Level: PT Classification code 10052337 Term: Diastolic dysfunction System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Inspra
Product Name: Eplerenone
Product Code: N/A
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Eplerenone
CAS Number: 107724-20-9
Current Sponsor code: None
Other descript
Sponsors
Solvotrin Innovations Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Over 18 years of age 2. Ability to give informed consent 3. Type II diabetes mellitus 4. Diastolic dysfunction on Doppler-echocardiogram as evidenced by either LAVI >32ml/m2 and/or e' =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Age 5.0 mmol/L before randomization 5. Recent admission for acute cardiovascular event (e.g. ischemia) 30% and/or proximal isovelocity surface area >0.4cm2) 8. Documented evidence (ECG) of atrial fibrillation 9. Prior documented LVEF 69mmol/mol 17. Diastolic BP >110 mmHg and a systolic BP >180 mmHg 18. Orthostatic hypertension, secondary hypertension or a history of severe or malignant hypertension 19. Any clinically significant, abnormal laboratory values that could preclude the patient from safely participating in the study. 20. Evidence of significant inflammatory disease, connective tissue disease, hepatic disease, metabolic bone disease which may alter parameters of collagen metabolism 21. Hypertrophic, restrictive or constrictive cardiomyopathy 22. Severe anaemia (Haemoglobin 3 times upper limit of normal 24. Recent major surgery (<6 months) (omit trauma) 25. Subjects with contraindications to MRI (including but not limited to) a. Hypersensitivity to gadolinium containing contrast agents b. Brain aneurysm clip c. Implanted neural stimulator d. Implanted cardiac pacemaker or defibrillator e. Cochlear implant f. Ocular foreign body (e.g. metal shavings) g. Other implanted medical devices: (e.g. Swan Ganz catheter) h. Implanted insulin pump i. Metal shrapnel or bullet. 26. Contraindications to eplerenone therapy: a. Hypersensitivity to eplerenone or any of the excipients. b. Medications interacting with eplerenone therapy taken within 30 days of randomisation: i. Patients receiving potassium-sparing diuretics, potassium-supplements ii. Patients taking strong inhibitors of CYP 3A4 (eg itraconazole, ketoconazole, ritonavir, nelfinavir, erythromycin, clarithromycin, telithromycin and nefazodone). iii. Patients taking strong CYP3A4 inducers (rifampicin, carbamazepine, phenytoin, phenobarbital, St John's Wort) should also be excluded as should patients treated with lithium, ciclosporin and tacrolimus. iv. Patients taking amiodarone, d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the change in Left Atrial Volume Index (LAVI), measured by magnetic resonance imaging (MRI) in the treated group vs. the untreated group;Secondary Objective: Change in the level of markers of collagen turnover Change in left ventricular mass index Change in Doppler-Echocardiogaphic markers of diastolic function including LAVI, mitral valve inflow pattern, tissue Doppler signal Change in the level of markers of inflammation ;Primary end point(s): The primary endpoint of this study is the difference in the change in Left Atrial Volume Index (LAVI), measured by MRI in diabetic patients with asymptomatic left ventricular diastolic dysfunction treated with eplerenone and those not treated with eplerenone;Timepoint(s) of evaluation of this end point: Baseline, 6 months and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in the level of markers of collagen turnover Change in left ventricular mass index Change in Doppler-Echocardiogaphic markers of diastolic function including LAVI, mitral valve inflow pattern, tissue Doppler signal Change in the level of markers of inflammation ;Timepoint(s) of evaluation of this end point: Baseline (time 0), 2, 4, 6, 8, 10, 12 months for markers of collagen turnover and inflammatory markers Echo doppler at 0, 6 and 12 months only | — |
Countries
Ireland
Contacts
Public ContactClinical Trials Information
Solvotrin Innovations
Outcome results
None listed