Biomarker Guided Discharge of Heart Failure Patients
Recruiting · NCT03103932 · Interventional (participants receive a specific treatment) · Lead sponsor: Ottawa Heart Institute Research Corporation
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This is a multi-centre, single blind, randomized study. Patients admitted to hospital with acute decompensated heart failure will be randomized to biomarker guided discharge algorithm vs usual care in a 2:1 ratio. NTproBNP and other biomarkers will be measured within 24 hours of admission. The NTproBNP results will be used to further stratify participants randomized to the biomarker guided group into lower and medium to higher risk pathways. Biomarkers will be repeated after 2-3 days and again prior to discharge. Specific care pathways will be followed for each of the lower risk and medium-higher risk groups. Biomarkers will be repeated 30 days post discharge. Participants will be followed with a phone call at 3 months and return for a follow up visit at 6 months post discharge for outcome evaluation.
Who can take part
Inclusion criteria
- Patients admitted to hospital with a primary diagnosis of acute decompensated heart failure, compatible with the modified Framingham criteria
Exclusion criteria
- Patient unable to provide blood samples or cannot participate in follow-up
- Patient with end stage organ failure
- Kidney: creatinine \>350 μmol/L or Estimated GFR ≤15 ml/min
- Liver dysfunction: liver function test \>2.5 times normal
- Lungs: pulmonary FEV1\<50% predicted
- Patient requiring intubation
- Patient with an admission NTproBNP measurement of \>30,000 pg/ml
- Patient listed for heart transplant, or admitted specifically for transplant workup
- Patient in cardiogenic shock
- Patient with life expectancy of less than 6 months, or has major co-morbidities such as new stroke, cancer, pneumonia, or other serious life threatening illness
- Patient with conditions that will make it difficult to discharge from hospital such as a fall or waiting for a long term care bed
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the trial, or may bias the result of the trial, or the patient's ability to participate in the trial
- Patient who has participated in another research trial involving an investigational product in the past 30 days
Where it is running
1 location listed.
- University of Ottawa Heart Institute - Ottawa, Ontario, Canada