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
  Purpose

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


Condition Intervention Phase
Congestive Heart Failure
Diabetes Mellitus
Drug: Intravenous insulin
Drug: Subcutaneous insulin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Glycemic Control and Variability for Congestive Heart Failure Exacerbation

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 75
Study Start Date: January 2009
Study Completion Date: September 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intravenous insulin Drug: Intravenous insulin
Patients will receive continuous insulin infusion through the vein.
Active Comparator: Subcutaneous Insulin
4 injections of insulin/day
Drug: Subcutaneous insulin
4 injections of insulin/day

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812487

Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Kathleen Dungan
Investigators
Principal Investigator: Kathleen M Dungan, MD Ohio State University
  More Information

No publications provided

Responsible Party: Kathleen Dungan, Assistant Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT00812487     History of Changes
Other Study ID Numbers: 2008H0087, 1R21DK081877-01
Study First Received: December 19, 2008
Results First Received: September 6, 2013
Last Updated: November 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Ohio State University:
congestive heart failure
diabetes mellitus
hyperglycemia

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Failure
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014