Acute Heart FailureNCT00922402
Heart & Diabetes - Feasibility Study
A study testing Intensive insulin infusion in people with Acute Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- Intensive insulin infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesItaly
- Study dates
- Jun 2009to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read the 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.
- Conditions
- Acute Heart Failure
- Being tested
- Intensive insulin infusion
- Keywords
- Acute, heart failure, hyperglycemia, Acute heart failure with high levels of glycemia
- Medical subject headings
- Heart Failure, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive insulin infusionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | All patients will be submitted to a shared intensive protocol of insulin infusion supported by continuous glucose monitoring Receives: Procedure: Intensive insulin infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average time to glycemic target (90-130 mg/dL)
Measured: Within two days after enrollment
Secondary outcomes (15)
Number of patient-days without deviations from the protocol
Measured: Within two days after enrollment
Average glycemia in the first 6 hours
Measured: Within six hours after enrollment
Slope of decremental curve of glycemia in the first 6 hours
Measured: Within six hours after enrollment
Median number of glycemia controls/patient in the first 12 hours
Measured: Within twelve hours after enrollment
Percentage of patients in glycemic range during the first 6 hours of infusion
Measured: Within six hours after enrollment
Number of hypoglycemia episodes in the first 5 days
Measured: Within five days after enrollment
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
Measured: Within five days after enrollment
HbA1c at 3 months and variation with respect to baseline
Measured: Within three months after enrollment
Number of hypoglycemia episodes in the follow-up
Measured: Within three months after enrollment
Evaluation of the number of finger-stick measurement and CGM readings
Measured: Within five days after enrollment
Evaluation of the correlation between finger-stick measurement and CGM readings
Measured: Within five days after enrollement
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
Measured: Within five days after enrollment
Number of times that finger-stick overruled CGM readings or alarms not to do any therapy adjustment
Measured: WIthin five days after enrollment
Evaluation of healthcare resource consumption
Measured: Within three months after enrollment
Evaluation of organizational impact
Measured: Within three months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Riccardo Vigneri, MD, Study chair, Garibaldi-Nesima Hospital - Catania - ItalyMaddalena Lettino, MD, Study chair, Policlinico S. Matteo - Pavia - ItalyMichele Gulizia, MD, Study chair, Garibaldi-Nesima Hospital - Catania - ItalyLuigi Magnani, MD, Study chair, Policlinico S. Matteo - Pavia - ItalyLuigi Tavazzi, MD, Study chair, Ospedale Villa Maria Cecilia - Gruppo Villa Maria - Cotignola (Ravenna) - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922402
- Sponsor's protocol ID
- Heart & Diabetes
- Status last verified
- Mar 2025
- First submitted
- 16 Jun 2009
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart & Diabetes - Feasibility Study
- ClinicalTrials.gov ID
- NCT00922402
- Acronym / sponsor ID
- Heart & Diabetes
- Conditions
- Acute Heart Failure
- Keywords
- Acute, heart failure, hyperglycemia, Acute heart failure with high levels of glycemia
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 17 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Procedure: Intensive insulin infusionAll patients will be submitted to a shared intensive protocol of insulin infusion supported by continuous glucose monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive insulin infusionThe 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. | Procedure or surgery | Treatment |
Primary outcome
Average time to glycemic target (90-130 mg/dL)
Time frame: Within two days after enrollment
15 secondary outcomes
Number of patient-days without deviations from the protocol
Time frame: Within two days after enrollment
Average glycemia in the first 6 hours
Time frame: Within six hours after enrollment
Slope of decremental curve of glycemia in the first 6 hours
Time frame: Within six hours after enrollment
Median number of glycemia controls/patient in the first 12 hours
Time frame: Within twelve hours after enrollment
Percentage of patients in glycemic range during the first 6 hours of infusion
Time frame: Within six hours after enrollment
Number of hypoglycemia episodes in the first 5 days
Time frame: Within five days after enrollment
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
Time frame: Within five days after enrollment
HbA1c at 3 months and variation with respect to baseline
Time frame: Within three months after enrollment
Number of hypoglycemia episodes in the follow-up
Time frame: Within three months after enrollment
Evaluation of the number of finger-stick measurement and CGM readings
Time frame: Within five days after enrollment
Evaluation of the correlation between finger-stick measurement and CGM readings
Time frame: Within five days after enrollement
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
Time frame: Within five days after enrollment
Number of times that finger-stick overruled CGM readings or alarms not to do any therapy adjustment
Time frame: WIthin five days after enrollment
Evaluation of healthcare resource consumption
Time frame: Within three months after enrollment
Evaluation of organizational impact
Time frame: Within three months after enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Riccardo Vigneri, MD study chair
Garibaldi-Nesima Hospital - Catania - Italy
Maddalena Lettino, MD study chair
Policlinico S. Matteo - Pavia - Italy
Michele Gulizia, MD study chair
Garibaldi-Nesima Hospital - Catania - Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive insulin infusion in people with Acute Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average time to glycemic target (90-130 mg/dL) (time frame: Within two days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.