Intensive Glycemic Control for Congestive Heart Failure Exacerbation

What Was Tested

The trial (phase 2) is built around Insulin (regular human).

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

It had two arms (groups): Intravenous Insulin (experimental) and Subcutaneous Insulin (active comparator).

Basal bolus insulin (4 injections per day).

The registry classes the interventions as drug.

More on the Plan

Patients with heart failure often have high blood sugar.

The researchers enrolled patients with severe heart failure and randomly assigned them into 2 groups.

The researchers used intravenous (given through the vein) insulin to lower blood sugar levels in group 1, and insulin injections in group 2.

Who Took Part

Enrollment: 74 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 18 and above. Admitted (less than 48 hours) to the OSU Ross Heart Hospital with worsening heart failure.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: receiving comfort care measures only; hospital stay expected to be less than 2 days; participation in the study on prior hospitalizations.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2009-01 with completion listed for 2013-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Hospital Length of Stay (time frame: Days).

It also tracked 5 secondary outcomes, for example Hospital Readmission, Heart Rate Variability, Change in Quality of Life, Brain Natriuretic Peptide (BNP) and Cardiac Output.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 74 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page, all human trials.