Clinical trial NCT03103932: Biomarker Guided Discharge of Heart Failure Patients
Official title: BiomarkeR cAndidates to Guide Discharge of Patients Admitted to Hospital With heARt Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure; With Decompensation
Keywords: biomarkers
heart failure
hospital admission
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
Collaborators: name: Genome Canada
name: Roche Diagnostics GmbH
name: Ottawa Heart Institute Research Corporation
First posted: 2017-04-07
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single blind, strategy based, randomized trial consisting of two main study arms
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: Care Pathways:

Usual care: Participants will be treated for their heart failure symptoms as is usual at each participating institution. NTproBNP results will not be revealed to the care providers.

NTproBNP levels of participants randomized to the biomarker guided discharge algorithm will be posted on the participant's medical records. The results will be used by the care providers for decision making according to the predetermined care pathway.

Lower risk group: Participants who's admission NTproBNP is below 3,000 pg/ml will be placed into the lower risk group. Discharge planning will start within 24 hours of hospital admission. Symptoms will be treated aggressively. If the NTproBNP level drops to 1,500 pg/ml or below on Day 2-3, the participant will be discharged home. If the NTproBNP level does not drop to below 1,500 pg/ml, the participant will continue on treatment for another day or two and be discharged home when medically stabilized.

Medium-higher risk group: Participants who's admission NTproBNP is 3,000 pg/ml or above will be placed into the medium-higher risk group. Symptoms will be treated aggressively. If the NTproBNP level drops to below 3,000 pg/ml on Day 2-3, the participant will follow the lower risk pathway until discharge. If the NTproBNP level remains above 3,000 pg/ml, aggressive treatment of symptoms will continue. Biomarkers will be repeated on Day 6-7. If the NTproBNP level has dropped by at least 30% from admission and the participant is medically stabilized, the participant will be discharged home. If the NTproBNP level has not dropped by at least 30% from admission, treatment will continue until the participant is medically stabilized. This last group will be discharged home on telehealth with daily monitoring.

All participants will complete a Quality of Life questionnaire at admission and at the 30 day post discharge follow up.

Eligibility criteria: 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

Primary outcomes:
measure: the total number of days alive and out of hospital during the first 30 days of heart failure diagnosis
timeFrame: Randomization to 30 days post randomization
measure: the total number of days alive and out of hospital during the first 30 days of heart failure diagnosis
timeFrame: Randomization to 30 days post randomization
measure: the total number of days alive and out of hospital during the first 30 days of heart failure diagnosis
timeFrame: Randomization to 30 days post randomization
Secondary outcomes:
measure: the total number of days alive and out of hospital during the first 6 months of follow up
timeFrame: Randomization to 6 months post randomization
measure: the total number of days alive and out of hospital during the first 6 months of follow up
timeFrame: Randomization to 6 months post randomization
measure: the total number of days alive and out of hospital during the first 6 months of follow up
timeFrame: Randomization to 6 months post randomization
Other outcomes:
measure: Total cost savings for hospitalizations over the course of the study
timeFrame: From enrollment of first patient to completion of the study - expected to be about 2 years
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Peter Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: