Clinical trial NCT00922402: Heart & Diabetes - Feasibility Study
Official title: Heart & Diabetes - Feasibility Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Heart Failure
Keywords: Acute
heart failure
hyperglycemia
Acute heart failure with high levels of glycemia
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2009-06-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 addition to reference finger-stick values.

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 and accounting for a significant proportion of healthcare costs. Recurrent hospital admissions represent the majority of the disease-related cost. About 15-25% of patients with HF are diabetics: the presence of diabetes significantly worsens prognosis in patients with heart failure and increases the risk of death by 30% compared to subject without diabetes.

The intensive control of glycemia during acute heart failure is an objective of primary importance, which can be obtained only with a proper strategy of patient management and with a considerable organizational effort. In a shared protocol aimed at a tight control of glycemia, the use of Continuous Glucose Monitoring (CGM) is expected to allow an easier management of the patient and a more accurate implementation of the protocol.

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 addition to reference finger-stick values.

Eligibility criteria: 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

Primary outcomes:
measure: Average time to glycemic target (90-130 mg/dL)
timeFrame: Within two days after enrollment
Secondary outcomes:
measure: Number of patient-days without deviations from the protocol
timeFrame: Within two days after enrollment
measure: Average glycemia in the first 6 hours
timeFrame: Within six hours after enrollment
measure: Slope of decremental curve of glycemia in the first 6 hours
timeFrame: Within six hours after enrollment
measure: Median number of glycemia controls/patient in the first 12 hours
timeFrame: Within twelve hours after enrollment
measure: Percentage of patients in glycemic range during the first 6 hours of infusion
timeFrame: Within six hours after enrollment
measure: Number of hypoglycemia episodes in the first 5 days
timeFrame: Within five days after enrollment
measure: Number of medical interventions and/or therapy variations based on blood glucose monitoring (finger-sticks) and/or suggested by interstitial continuous glucose monitoring glucose monitoring in the first 5 days
timeFrame: Within five days after enrollment
measure: HbA1c at 3 months and variation with respect to baseline
timeFrame: Within three months after enrollment
measure: Number of hypoglycemia episodes in the follow-up
timeFrame: Within three months after enrollment
measure: Evaluation of the number of finger-stick measurement and CGM readings
timeFrame: Within five days after enrollment
measure: Evaluation of the correlation between finger-stick measurement and CGM readings
timeFrame: Within five days after enrollement
measure: Number of times that therapy was changed after finger-stick confirmation when CGM values or alarms were indicating a therapy adjustment needs to be made
timeFrame: Within five days after enrollment
measure: Number of times that finger-stick overruled CGM readings or alarms not to do any therapy adjustment
timeFrame: WIthin five days after enrollment
measure: Evaluation of healthcare resource consumption
timeFrame: Within three months after enrollment
measure: Evaluation of organizational impact
timeFrame: Within three months after enrollment
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Garibaldi Nesima Hospital
city: Pavia
country: Italy
facility: Policlinico S. Matteo
Study officials:
affiliation: Garibaldi-Nesima Hospital - Catania - Italy
name: Riccardo Vigneri, MD
role: STUDY_CHAIR
affiliation: Policlinico S. Matteo - Pavia - Italy
name: Maddalena Lettino, MD
role: STUDY_CHAIR
affiliation: Garibaldi-Nesima Hospital - Catania - Italy
name: Michele Gulizia, MD
role: STUDY_CHAIR
affiliation: Policlinico S. Matteo - Pavia - Italy
name: Luigi Magnani, MD
role: STUDY_CHAIR
affiliation: Ospedale Villa Maria Cecilia - Gruppo Villa Maria - Cotignola (Ravenna) - Italy
name: Luigi Tavazzi, MD
role: STUDY_CHAIR
References: