Biomarker Guided Discharge of Heart Failure Patients

NCT03103932 | Recruiting DMC

• 1 other identifier: 806
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; With Decompensation

Keywords

biomarkers; heart failure; hospital admission

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• the total number of days alive and out of hospital during the first 6 months of follow up

  Randomization to 6 months post randomization

• the total number of days alive and out of hospital during the first 6 months of follow up

  Randomization to 6 months post randomization

• the total number of days alive and out of hospital during the first 6 months of follow up

  Randomization to 6 months post randomization

Other Outcomes (1)

• Total cost savings for hospitalizations over the course of the study

  From enrollment of first patient to completion of the study - expected to be about 2 years

Study Arms (2)

Usual care

NO INTERVENTION

Participants will be treated as is usual at each institution. Biomarkers will be measured on Day 2-3 and again prior to discharge from hospital. NTproBNP levels will not be revealed to care providers.

Biomarker guided discharge pathway

EXPERIMENTAL

Admission NTproBNP levels will be used to stratify participants into lower and medium-higher risk care pathways. NTproBNP levels will be repeated on Day 2-3 and again prior to discharge. Each care pathway is designed to optimize discharge time according to NTproBNP levels. All NTproBNP results will be displayed on the front of the participant's chart along with the care pathway that the participant has been randomized to. The care providers will be reminded daily by the study team that the participant is in the biomarker guided discharge pathway arm of the study and that the designated care pathway should be followed as closely as possible.

Other: Biomarker guided discharge algorithm

Interventions

Biomarker guided discharge algorithm OTHER

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

Biomarker guided discharge pathway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to hospital with a primary diagnosis of acute decompensated heart failure, compatible with the modified Framingham criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• Genome Canada: collaborator
• Roche Diagnostics GmbH: collaborator
• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Peter Liu, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ermina Moga, MD

CONTACT

613-696-7000; emoga@ottawaheart.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The assigned care pathway will not be revealed to the participant NTproBNP levels will not be revealed to care providers for the group randomized to usual care.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single blind, strategy based, randomized trial consisting of two main study arms

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 7, 2017
• Study Start: August 26, 2017
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)