Cardiovascular fysiological effects of Exenatide on heart failure

• Conditions: 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.; MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus; MedDRA version: 9.1Level: LLTClassification code 10066159Term: Decompensated heart failure

• Registration Number: EUCTR2006-005220-16-SE
• Lead Sponsor: Karolinska institutet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

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