University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
Location status: Recruiting
NCT Number: NCT03103932
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Ottawa, Ontario, K1Y 4W7, Canada
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Randomization to 30 days post randomization
The investigator will measure te total number of days in hospital for each group
Time frame: Randomization to 30 days post randomization
The investigator will measure the number of rehospitalizations in each group
Time frame: Randomization to 30 days post randomization
The investigator will measure the total number of deaths and hospitalization episodes in each group
Time frame: Randomization to 6 months post randomization
The investigator will measure the total number of days in hospital in each group
Time frame: Randomization to 6 months post randomization
The investigator will measure The number of rehospitalizations in each group
Time frame: Randomization to 6 months post randomization
The investigator will measure the number of deaths/hospitalization episodes in each group
Time frame: From enrollment of first patient to completion of the study - expected to be about 2 years
The investigator will measure the cost associated with each hospitalization in each group
Contact information is provided by the study sponsor or research team.
Ottawa Heart Institute Research Corporation
Other
BiomarkeR cAndidates to Guide Discharge of Patients Admitted to Hospital With heARt Failure
Acronym: RADAR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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