Heart & Diabetes - Feasibility Study

Acute Heart Failure Clinical Trial

Official title:

Heart & Diabetes - Feasibility Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00922402
• Other study ID #: Heart & Diabetes
• Status: Withdrawn
• Phase: N/A
• First received: June 16, 2009
• Last updated: March 23, 2016
• Start date: June 2009
• Est. completion date: September 2011

Study information

• Verified date: March 2016
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Procedure:
• Intensive insulin infusion
The intensive control of glycemia is obtained with a shared in-hospital insulin infusion protocol, supported by the use of a continuous glucose monitoring system (Medtronic Guardian REAL Time). Any sudden variation of glycemia levels and/or alarms, as indicated by the device, has to be confirmed with a finger-stick before any therapy modification. In-hospital management is subdivided in a 2-day intensive and a 3-day post-intensive phase.

Locations

Country	Name	City	State
Italy	Garibaldi Nesima Hospital	Catania
Italy	Policlinico S. Matteo	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average time to glycemic target (90-130 mg/dL)		Within two days after enrollment	No
Secondary	Number of patient-days without deviations from the protocol		Within two days after enrollment	No
Secondary	Average glycemia in the first 6 hours		Within six hours after enrollment	No
Secondary	Slope of decremental curve of glycemia in the first 6 hours		Within six hours after enrollment	No
Secondary	Median number of glycemia controls/patient in the first 12 hours		Within twelve hours after enrollment	No
Secondary	Percentage of patients in glycemic range during the first 6 hours of infusion		Within six hours after enrollment	No
Secondary	Number of hypoglycemia episodes in the first 5 days		Within five days after enrollment	Yes
Secondary	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		Within five days after enrollment	No
Secondary	HbA1c at 3 months and variation with respect to baseline		Within three months after enrollment	No
Secondary	Number of hypoglycemia episodes in the follow-up		Within three months after enrollment	Yes
Secondary	Evaluation of the number of finger-stick measurement and CGM readings		Within five days after enrollment	No
Secondary	Evaluation of the correlation between finger-stick measurement and CGM readings		Within five days after enrollement	No
Secondary	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		Within five days after enrollment	No
Secondary	Number of times that finger-stick overruled CGM readings or alarms not to do any therapy adjustment		WIthin five days after enrollment	No
Secondary	Evaluation of healthcare resource consumption		Within three months after enrollment	No
Secondary	Evaluation of organizational impact		Within three months after enrollment	No