Glycemic Control and Variability for Congestive Heart Failure Exacerbation

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kathleen Dungan, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00812487
First received: December 19, 2008
Last updated: November 9, 2013
Last verified: November 2013

December 19, 2008
November 9, 2013
January 2009
August 2012   (final data collection date for primary outcome measure)
  • Hospital Length of Stay [ Time Frame: participants were followed for the duration of hospital stay, median hospital stay 8 day ] [ Designated as safety issue: No ]
    Duration of hospitalization
  • Hospital Readmission [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    All-cause hospital readmission within 30 days
Glycemic Variability [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00812487 on ClinicalTrials.gov Archive Site
  • High Frequency Heart Rate Variability [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    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) [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    Laboratory analyses were performed by the study institution's Clinical Research Center using standard commercial kits
  • Quality of Life [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    CV is a measure of glycemic variability
  • Mean Glucose [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    mean sensor glucose
  • Heart rate variability [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Cardiac Index [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Inflammatory markers [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • BNP [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
  • Adiponectin [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • oxidative stress [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Glycemic Control and Variability for Congestive Heart Failure Exacerbation
Glycemic Control and Variability for Congestive Heart Failure Exacerbation

High glucose as well as fluctuations (rapid swings) in blood glucose can contribute to severe hospital complications and even death.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Congestive Heart Failure
  • Diabetes Mellitus
  • Drug: Intravenous insulin
    Patients will receive continuous insulin infusion through the vein.
  • Drug: Subcutaneous insulin
    4 injections of insulin/day
  • Experimental: Intravenous insulin
    Intervention: Drug: Intravenous insulin
  • Active Comparator: Subcutaneous Insulin
    4 injections of insulin/day
    Intervention: Drug: Subcutaneous insulin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
September 2013
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00812487
2008H0087, 1R21DK081877-01
Yes
Kathleen Dungan, The Ohio State University
Kathleen Dungan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Kathleen M Dungan, MD Ohio State University
Ohio State University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP