Heart & Diabetes - Feasibility Study

NCT00922402 | Withdrawn

• 1 other identifier: Heart & Diabetes
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Heart Failure

Keywords

Acute; heart failure; hyperglycemia; Acute heart failure with high levels of glycemia

Outcome Measures

Primary Outcomes (1)

• Average time to glycemic target (90-130 mg/dL)

  Within two days after enrollment

Secondary Outcomes (15)

• Number of patient-days without deviations from the protocol

  Within two days after enrollment

• Average glycemia in the first 6 hours

  Within six hours after enrollment

• Slope of decremental curve of glycemia in the first 6 hours

  Within six hours after enrollment

• Median number of glycemia controls/patient in the first 12 hours

  Within twelve hours after enrollment

• Percentage of patients in glycemic range during the first 6 hours of infusion

  Within six hours after enrollment

Study Arms (1)

Treatment

EXPERIMENTAL

All patients will be submitted to a shared intensive protocol of insulin infusion supported by continuous glucose monitoring

Procedure: Intensive insulin infusion

Interventions

Intensive insulin infusion PROCEDURE

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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (2)

Garibaldi Nesima Hospital

Catania, Italy

Location

Policlinico S. Matteo

Pavia, Italy

Location

MeSH Terms

Conditions

Heart Failure; Hyperglycemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Riccardo Vigneri, MD

  Garibaldi-Nesima Hospital - Catania - Italy

  STUDY CHAIR

• Maddalena Lettino, MD

  Policlinico S. Matteo - Pavia - Italy

  STUDY CHAIR

• Michele Gulizia, MD

  Garibaldi-Nesima Hospital - Catania - Italy

  STUDY CHAIR

• Luigi Magnani, MD

  Policlinico S. Matteo - Pavia - Italy

  STUDY CHAIR

• Luigi Tavazzi, MD

  Ospedale Villa Maria Cecilia - Gruppo Villa Maria - Cotignola (Ravenna) - Italy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: June 17, 2009
• Study Start: June 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 3, 2025

Record last verified: 2025-03

Locations

IT (2)