Recruiting

Observational Study

Sponsor:

Ottawa Heart Institute Research Corporation

Code:

NCT03103932

Conditions

Heart Failure; With Decompensation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biomarker guided discharge algorithm

Study Details

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

Study ID

NCT03103932

Start date

Aug 26, 2017

Status verified date

Jan, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

750 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Usual care

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.

experimental: Biomarker guided discharge pathway

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.

Interventions

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

Primary outcome measure

  • the total number of days alive and out of hospital during the first 30 days of heart failure diagnosis [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Randomization to 30 days post randomization ]

Central Contacts and Locations

Central contacts

Ermina Moga, MD

613-696-7000emoga@ottawaheart.ca

Locations

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

Contacts

Ermina Moga, MD

613-696-7000emoga@ottawaheart.ca

More Information

Sponsor

Ottawa Heart Institute Research Corporation

Last update posted

May 6, 2026

Last verified

Jan, 2026

Keywords

  • biomarkers
  • heart failure
  • hospital admission

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Heart Institute Research Corporation on 2026-05-06.