Glycemic Control and Variability for Congestive Heart Failure Exacerbation
Primary Purpose
Congestive Heart Failure, Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Intravenous insulin
Subcutaneous insulin
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring congestive heart failure, diabetes mellitus, hyperglycemia
Eligibility Criteria
Inclusion Criteria:
- Age 18 and above
- Admitted (less than 48 hours) to the with worsening heart failure
- Hyperglycemia or diabetes. Hyperglycemia is defined as blood glucose greater than 150 mg/dL on at least 2 occasions separated by at least 4 hours apart, insulin use, or HbA1c >6.5%.
Exclusion Criteria:
- Type 1 diabetes
- Receiving comfort care measures only
- Hospital stay expected to be less than 2 days
- Pregnancy
- Prisoners
- Participation in the study on prior hospitalizations
- Acute myocardial infarction within 3 months
- End stage renal or liver disease
Sites / Locations
- The Ohio State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intravenous insulin
Subcutaneous Insulin
Arm Description
4 injections of insulin/day
Outcomes
Primary Outcome Measures
Hospital Length of Stay
Duration of hospitalization
Hospital Readmission
All-cause hospital readmission within 30 days
Secondary Outcome Measures
High Frequency Heart Rate Variability
High frequency heart rate variability (HF HRV)is a measure of cardiac autonomic tone. Electrocardiographic measures were obtained using a Bionex system (Mindware, Gahanna, OH). The electrocardiogram was performed in the standard lead II configuration. Software (Mindware, Gahanna, OH) was used to derive HF HRV. HF HRV was calculated using power spectral analysis.
Pre-ejection Period (PEP)
Pre-ejection period (PEP) is the time between the onset of electrical depolarization of the ventricle and the opening of the aortic valve, a measure of sympathetic tone. It is obtained noninvasively using cardiac impedance obtained using a Bionex system (Mindware, Gahanna, OH). PEP is measured in milliseconds; lower values reflect higher sympathetic tone.
High Sensitivity C-reactive Protein (Hs-CRP)
High sensitivity C-reactive Protein (hs-CRP) is a measure of inflammation. hsCRP (range 0-15 mg/L) was performed using Immunlite 1000 assay (Siemens; Erlangen, Germany).
Brain Natriuretic Peptide (BNP)
Laboratory analyses were performed by the study institution's Clinical Research Center using standard commercial kits
Quality of Life
Quality of Life was measured using the Minnesota Living with Heart Failure Questionnaire, which is a 21 question survey that uses a likert scale of 0-5. Each item asks over the past 4 weeks whether they have had a particular symptom of heart failure and to classify the response as no symptoms (0) to having the symptom very much (5). Responses are summed for a total score (0-105).
Glycemic Lability Index (GLI)
GLI is a measure of glycemic variability. GLI is the sum of the square of the difference between successive glucose measurements divided by the difference in time between measurements
Coefficient of Variation (CV)
CV is a measure of glycemic variability
Mean Glucose
mean sensor glucose
Full Information
NCT ID
NCT00812487
First Posted
December 19, 2008
Last Updated
November 9, 2013
Sponsor
Kathleen Dungan
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00812487
Brief Title
Glycemic Control and Variability for Congestive Heart Failure Exacerbation
Official Title
Glycemic Control and Variability for Congestive Heart Failure Exacerbation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kathleen Dungan
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
High glucose as well as fluctuations (rapid swings) in blood glucose can contribute to severe hospital complications and even death.
Detailed Description
High glucose as well as fluctuations in blood glucose can contribute to severe hospital complications and even death. Studies also suggest that heart failure patients who have high glucose or diabetes do not live as long as patients with normal glucose. Glucose fluctuations have not been well-studied in patients with heart failure. In this study, we will determine whether better control of blood sugar fluctuations in the hospital improve outcomes. We will enroll 80 patients with severe heart failure and divide them into 2 groups. We will use intravenous (given through the vein) insulin to lower blood sugar levels in group 1, and insulin injections (under the skin) in group 2. We will determine whether intravenous insulin improves blood markers of inflammation, changes in vital signs, and other tests that predict mortality in patients with heart failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Diabetes Mellitus
Keywords
congestive heart failure, diabetes mellitus, hyperglycemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intravenous insulin
Arm Type
Experimental
Arm Title
Subcutaneous Insulin
Arm Type
Active Comparator
Arm Description
4 injections of insulin/day
Intervention Type
Drug
Intervention Name(s)
Intravenous insulin
Intervention Description
Patients will receive continuous insulin infusion through the vein.
Intervention Type
Drug
Intervention Name(s)
Subcutaneous insulin
Intervention Description
4 injections of insulin/day
Primary Outcome Measure Information:
Title
Hospital Length of Stay
Description
Duration of hospitalization
Time Frame
participants were followed for the duration of hospital stay, median hospital stay 8 day
Title
Hospital Readmission
Description
All-cause hospital readmission within 30 days
Time Frame
30 days
Secondary Outcome Measure Information:
Title
High Frequency Heart Rate Variability
Description
High frequency heart rate variability (HF HRV)is a measure of cardiac autonomic tone. Electrocardiographic measures were obtained using a Bionex system (Mindware, Gahanna, OH). The electrocardiogram was performed in the standard lead II configuration. Software (Mindware, Gahanna, OH) was used to derive HF HRV. HF HRV was calculated using power spectral analysis.
Time Frame
24 hours
Title
Pre-ejection Period (PEP)
Description
Pre-ejection period (PEP) is the time between the onset of electrical depolarization of the ventricle and the opening of the aortic valve, a measure of sympathetic tone. It is obtained noninvasively using cardiac impedance obtained using a Bionex system (Mindware, Gahanna, OH). PEP is measured in milliseconds; lower values reflect higher sympathetic tone.
Time Frame
24 hours
Title
High Sensitivity C-reactive Protein (Hs-CRP)
Description
High sensitivity C-reactive Protein (hs-CRP) is a measure of inflammation. hsCRP (range 0-15 mg/L) was performed using Immunlite 1000 assay (Siemens; Erlangen, Germany).
Time Frame
72 hours
Title
Brain Natriuretic Peptide (BNP)
Description
Laboratory analyses were performed by the study institution's Clinical Research Center using standard commercial kits
Time Frame
72 hours
Title
Quality of Life
Description
Quality of Life was measured using the Minnesota Living with Heart Failure Questionnaire, which is a 21 question survey that uses a likert scale of 0-5. Each item asks over the past 4 weeks whether they have had a particular symptom of heart failure and to classify the response as no symptoms (0) to having the symptom very much (5). Responses are summed for a total score (0-105).
Time Frame
30 days
Title
Glycemic Lability Index (GLI)
Description
GLI is a measure of glycemic variability. GLI is the sum of the square of the difference between successive glucose measurements divided by the difference in time between measurements
Time Frame
24 hours
Title
Coefficient of Variation (CV)
Description
CV is a measure of glycemic variability
Time Frame
24 hours
Title
Mean Glucose
Description
mean sensor glucose
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 and above
Admitted (less than 48 hours) to the with worsening heart failure
Hyperglycemia or diabetes. Hyperglycemia is defined as blood glucose greater than 150 mg/dL on at least 2 occasions separated by at least 4 hours apart, insulin use, or HbA1c >6.5%.
Exclusion Criteria:
Type 1 diabetes
Receiving comfort care measures only
Hospital stay expected to be less than 2 days
Pregnancy
Prisoners
Participation in the study on prior hospitalizations
Acute myocardial infarction within 3 months
End stage renal or liver disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen M Dungan, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
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Glycemic Control and Variability for Congestive Heart Failure Exacerbation
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