Renal Optimization Strategies Evaluation in Acute Heart Failure and Reliable Evaluation of Dyspnea in the Heart Failure Network (ROSE) Study

What Was Tested

In this phase 2 trial, researchers set out to test BNP (Nesiritide).

There is a substudy in a subset of subjects that is being used to determine whether the Provocative Dyspnea Severity Score (pDSS) is a more sensitive index of variability in clinical status than the dyspnea VAS assessed without standardization of conditions at assessments.

It had three arms (groups): one (active comparator), Placebo (placebo comparator) and one (active comparator).

The registry classes the interventions as drug and other.

More on the Plan

Although there are no FDA approved renal adjuvant therapies for AHF, several novel adjuvant therapies for use in AHF are being investigated in randomized clinical trials.

However, these strategies have not been investigated.

Participation in this study will last 6 months.

The same evaluations and procedures will be repeated at various points during the study.

Who Took Part

The registry lists 360 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: Male or female patient ≥18 years old. Willingness to provide informed consent. Ability to have a PICC or central line placed (if needed) within 12 hours of randomization and study drug infusion started. Anticipated hospitalization of at least 72 hours.

The full record lists 7 inclusion and 24 exclusion criteria; among the exclusions: systolic bp \<90 mmhg; renal replacement therapy; active myocarditis.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the BNP (Nesiritide) group and the comparison group should start out alike.

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

Neither the participants nor the staff measuring them knew who was on BNP (Nesiritide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2010-08 with completion listed for 2013-05.

It ran at 8 sites in United States (7) and Canada (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Cystatin C (time frame: Randomization to 72 hours). Change in Dyspnea Assessment (RED-ROSE Substudy) (time frame: Baseline to 72 hours). Decongestive Changes- RED-ROSE (time frame: Baseline to 72 hours).

It also tracked 11 secondary outcomes, for example Change in Weight, Worst Reported Symptom Changes-RED-ROSE, Change in Clinical Stability- RED-ROSE, Change in Serum Creatinine, Dyspnea Visual Analog Scale Area Under the Curve and Change in Treatment Response.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of BNP (Nesiritide) in 360 people.

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

More context: the BNP (Nesiritide) compound page, all human trials.