Effect of exenatide in type 2 diabetic patients with congestive heart failure

Not Applicable

Completed

• Conditions: eft venticular heart failure and Type 2 diabetes mellitus; Nutritional, Metabolic, Endocrine; Left ventricular failure, Non-insulin-dependent diabetes mellitus

• Registration Number: ISRCTN47533126
• Lead Sponsor: Stockholm South General Hospital (Södersjukhuset AB) (Sweden)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-04
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Type 2 diabetes patients with LVHF and NYHA class III or IV symptoms of heart failure who are admitted to the hospital for management of decompensated chronic heart failure
2. A stable period of 24 hours using established therapy, i.e. ACE/ARB-inhibitors, beta-blockers, aldosterone-inhibitors and diuretics
3. Patients who are monitored with a pulmonary artery catheter for clinical purposes
4. In subjects without known diabetes, diabetes will be confirmed by at least two fasting plasma glucose levels exceeding 7 mmol/l or a random plasmaglucose exceeding 11,0 mmol/l according to the American Diabetes Association definition of diabetes
5. Male and female subjects
6. 18-80 years of age

Exclusion Criteria

1. Type 1 diabetes (autoantibody positive)
2. Need of inotropic agents, nitroglycerin-infusion or aortic balloon device
3. Unstable LVHF despite maximal oral treatments and i.v. diuretics
4. Significant ischemic heart disease (defined as angina-limited exercise or unstable angina); documented acute myocardial infarction (MI) within the previous 8 weeks
5. Active myocarditis; malfunctioning artificial heart valve
6. Symptomatic primary pulmonary disease; serious arrhythmias, defined as a history of ventricular flutter or fibrillation other than that occurring within 24 hours after acute MI
7. History of sudden cardiac death or symptomatic ventricular tachycardia within 3 months before study entry; second or third degree atrioventricular block, unless the patient has a functioning implanted pacemaker
8. Supine systolic blood pressure <85 mm Hg or >200 mm Hg
9. Primary renal impairment (creatinine clearance < 30 ml/min)
10. Uncorrected hypokalemia or hyperkalemia (potassium <3.5 mmol/l or >5.5 mmol/l)
11. Significant anemia (Hb < 90 g/l), or treatment with another investigational agent within 30 days before study entry
12. Severe gastrointestinal disease, including gastroparesis
13. Pregnancy or lactation
14. History of drug abuse
15. Presence or history of allergic reaction or intolerance to multiple drugs
16. Subjects considered by the Investigator as unsuitable candidates to receive an investigational drug
17. Known history of, or concomitant medical condition that might interfere with the evaluation of study medication
18. No minor subjects (<18 years of age) or pregnant women will be participating in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Serum biomarkers like BNP, NEFA, plasma glucose, S-insulin, S-C-peptide are monitored at multiple time points during the infusions<br>2. Serum levels of exenatide as follows:<br>2.1. During infusion (exenatide vs placebo), CI and PCWP are measured at baseline, 1 hour, 3 hours and 6 hours.<br>2.2. During the 18 hour washout period, another two measurements are made and infusion is repeated (exenatide vs placebo) with new measurements (baseline, 1 hour, 3 hours and 6 hours)<br>2.3. Blood samples are drawn at baseline (0) and at 30 min and every hour, until 6 hours (totally 7 blood samples are drawn)

Secondary Outcome Measures

Name	Time	Method
1. Mean arterial blood pressure <br>2. Mean pulmonary arterial pressure<br>3. Tolerability of exenatide in this acute setting