Biomarker Guided Discharge of Heart Failure Patients

Heart Failure; With Decompensation Clinical Trial

— RADAR  

Official title:

BiomarkeR cAndidates to Guide Discharge of Patients Admitted to Hospital With heARt Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03103932
• Other study ID #: 806
• Status: Recruiting
• Phase: N/A
• Start date: August 26, 2017
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Ottawa Heart Institute Research Corporation
• Contact: Ermina Moga, MD
• Phone: 613-696-7000
• Email: emoga[@]ottawaheart.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: December 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure; With Decompensation

Intervention

Other:
• Biomarker guided discharge algorithm
participants randomized to the biomarker guided discharge algorithm will follow a pre-determined care pathway for treatment of heart failure symptoms based on admission NTproBNP levels

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Peter Liu	Genome Canada, Ottawa Heart Institute Research Corporation, Roche Diagnostics

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total cost savings for hospitalizations over the course of the study	The investigator will measure the cost associated with each hospitalization in each group	From enrollment of first patient to completion of the study - expected to be about 2 years
Primary	the total number of days alive and out of hospital during the first 30 days of heart failure diagnosis	The investigator will measure te total number of days in hospital for each group	Randomization to 30 days post randomization
Primary	the total number of days alive and out of hospital during the first 30 days of heart failure diagnosis	The investigator will measure the number of rehospitalizations in each group	Randomization to 30 days post randomization
Primary	the total number of days alive and out of hospital during the first 30 days of heart failure diagnosis	The investigator will measure the total number of deaths and hospitalization episodes in each group	Randomization to 30 days post randomization
Secondary	the total number of days alive and out of hospital during the first 6 months of follow up	The investigator will measure the total number of days in hospital in each group	Randomization to 6 months post randomization
Secondary	the total number of days alive and out of hospital during the first 6 months of follow up	The investigator will measure The number of rehospitalizations in each group	Randomization to 6 months post randomization
Secondary	the total number of days alive and out of hospital during the first 6 months of follow up	The investigator will measure the number of deaths/hospitalization episodes in each group	Randomization to 6 months post randomization