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Completed

NCT Number: NCT00812253

Intensive Glycemic Control for Congestive Heart Failure Exacerbation

Patients with heart failure often have high blood sugar (glucose).

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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 2

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

Patients with heart failure often have high blood sugar. High glucose contributes to severe hospital complications and even death. Studies suggest that heart failure patients who have high glucose or diabetes do not live as long as patients with normal glucose. In this study, we will determine whether normalizing blood sugars using intravenous insulin short-term will improve outcomes in patients hospitalized for congestive heart failure. We enrolled patients with severe heart failure and randomly assigned them into 2 groups. We used intravenous (given through the vein) insulin to lower blood sugar levels in group 1, and insulin injections in group 2. We determined whether intravenous insulin improved hospital length of stay, rates of readmission, inflammatory markers, and cardiovascular 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 OSU Ross Heart Hospital 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

Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.

Subcutaneous insulin

Drug

Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.

Primary outcomes

  1. Hospital Length of Stay

    Time frame: Days

    Duration of hospitalization in days

Secondary outcomes

  1. Hospital Readmission

    Time frame: 30 days

    All-cause hospital readmission at 30 days after discharge

  2. Heart Rate Variability

    Time frame: 72 hours

    High frequency (HF) Heart rate variability (HRV). HRV was assessed with a Bionex system (Mindware, Gahanna, OH). The electrocardiogram was performed in the standard lead II configuration and impedance cardiography was performed using a standard tetrapolar arrangement. Measures were performed at baseline and each morning (0800-1000 hour) during and following the intervention for 7 minutes each. Software (Mindware, Gahanna, OH) was used to derive HF HRV. The middle five minutes of the recordings were scored minute by minute and the first suitable1 minute period was used for calculation. Five minute epochs were not feasible due to an unexpectedly high frequency of ectopy. One minute intervals allow calculation of HF (parasympathetic tone) but not low frequency (combination of sympathetic and parasympathetic tone).

  3. Change in Quality of Life

    Time frame: 30 day

    Change in Quality of Life questionnaire measured from baseline (enrollment) to 30 days following discharge. The questionnaire is a self-administered disease-specific questionnaire for patients with HF, comprising 21 items rated on six-point Likert scales, representing different degrees of impact of HF on health related quality of life, from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL),

  4. Brain Natriuretic Peptide (BNP)

    Time frame: 72 hours

    Brain natriuretic peptide (BNP) was measured at day 3

  5. Cardiac Output

    Time frame: 72 hours

    Cardiac output measured using impedance cardiography at 72 hours.

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
2013
Study completion
2014
First posted
Dec 22, 2008
Registry last updated
Jan 2, 2018

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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