E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
We are studying a diabetic ( type II) population with decompensated heart failure. Our aim is to see wether Cardiac index and "wedge pressure", measured by heart catheterization, can improve with an infusion of Exenatide. Studied at a diabetic ( type II) population with decompansated heart failure. Patients with acute myocardial ischemia will be excluded. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II diabetes mellitus |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066159 |
E.1.2 | Term | Decompensated heart failure |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Can a 6- hour infusion of Exenatide increase cardiac index, measured by heart catheterization, with 25% at a diabetic population ( type II) with decompensated heart failure? |
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E.2.2 | Secondary objectives of the trial |
Can a 6- hour infusion of Exenatide decrease "wedge pressure", measured by heart catheterization, with 25% at a diabetic population ( type II) with decompensated heart failure? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1: Decompensated heart failure ( NYHA 3-4) despite optimal treatment with diuretics and ACE inhibitors/ AT II antagonists. 2: Type II diabetes. 3: Ejection fraction < 35%, measured by doppler echocardiografia. 4: Admission to hospital. |
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E.4 | Principal exclusion criteria |
1: Type 1 diabetes. 2: Cancer. 3: Acute infection. 4: Myocardial infarction or unstable angina pectoris the last 2 months before randomisation. 5: Renal failure (creatinine clearence < 30 ml/min) 6: Active psychiatric diease. 7: Anemia ( Hb < 90 g/l) 8: Pregnancy
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of subjects achieving a 25 % relative increase in Cardiac Index (l/min/m2) after 6 hours infusion of Exenatide, measured with thermo dilution technique. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The study will end when the last study subject treated with placebo/ active drug. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |