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Completed

NCT Number: NCT00812487

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.

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Heart Failure Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous insulin

Drug

Patients will receive continuous insulin infusion through the vein.

Subcutaneous insulin

Drug

4 injections of insulin/day

Primary outcomes

  1. Hospital Length of Stay

    Time frame: participants were followed for the duration of hospital stay, median hospital stay 8 day

    Duration of hospitalization

  2. Hospital Readmission

    Time frame: 30 days

    All-cause hospital readmission within 30 days

Secondary outcomes

  1. High Frequency Heart Rate Variability

    Time frame: 24 hours

    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.

  2. Pre-ejection Period (PEP)

    Time frame: 24 hours

    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.

  3. High Sensitivity C-reactive Protein (Hs-CRP)

    Time frame: 72 hours

    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).

  4. Brain Natriuretic Peptide (BNP)

    Time frame: 72 hours

    Laboratory analyses were performed by the study institution's Clinical Research Center using standard commercial kits

  5. Quality of Life

    Time frame: 30 days

    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).

  6. Glycemic Lability Index (GLI)

    Time frame: 24 hours

    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

  7. Coefficient of Variation (CV)

    Time frame: 24 hours

    CV is a measure of glycemic variability

  8. Mean Glucose

    Time frame: 24 hours

    mean sensor glucose

Sponsors and collaborators

Lead sponsor

Kathleen Dungan

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Dec 22, 2008
Registry last updated
Dec 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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