Biomarker Guided Discharge of Heart Failure Patients — RADAR  

Heart Failure; With Decompensation Clinical Trial

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

Status Recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure; With Decompensation

• NCT number: NCT03103932
• Study type: Interventional
• Source: Ottawa Heart Institute Research Corporation
• Contact: Ermina Moga, MD
• Phone: 613-696-7000
• Email: emoga@ottawaheart.ca
• Status: Recruiting
• Phase: N/A
• Start date: August 26, 2017
• Completion date: December 2025