Status:
WITHDRAWN
Heart & Diabetes - Feasibility Study
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Acute Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The main purpose of this study is to validate an intensive protocol of insulin infusion and subsequent subcutaneous insulin administration with the support of continuous glucose monitoring, in additio...
Detailed Description
Heart failure is a common disease (prevalence worldwide: 22 million; incidence worldwide: 2 million; prevalence in Italy: 750.000; incidence in Italy: 170.000), affecting 1-2% of overall population an...
Eligibility Criteria
Inclusion
- Inclusion Criteria (all of the following inclusion criteria must be met for the patient to be enrolled in the study):
- acute heart failure, defined according to current ESC Guidelines
- HbA1c \> 7.5% at admission in Cardiology Unit
- glycemia \> 180 mg/dL at admission in Cardiology Unit
- the patients signed the Informed Consent
- Exclusion Criteria (if any of the following criteria are met, patients cannot be enrolled in the study):
- heart failure in acute infarction or cardiogenic shock
- creatinemia \> 3.5 mg/dL at admission or in hemodialytic therapy
- cirrhosis
- acute infective pathology
- cardiac revascularization during the hospitalization or in the preceding 3 months
- life expectance \< 12 months
- age \< 18 years
- pregnant women
- informed consent not signed
- subject included in other protocols
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00922402
Start Date
June 1 2009
End Date
September 1 2011
Last Update
July 3 2025
Active Locations (2)
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1
Garibaldi Nesima Hospital
Catania, Italy
2
Policlinico S. Matteo
Pavia, Italy