[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

613-696-7000

Email address

ecoletta@ottawaheart.ca

Condition

Heart Failure; With Decompensation

Treatment type

Interventional

Investigational product

Biomarker guided discharge algorithm

Phase

N/A

Sponsor

Ottawa Heart Institute Research Corporation

ClinicalTrials.gov identifier

NCT03103932

Study number

806

Understanding clinical trials

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About the study

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.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

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

  1. Patient unable to provide blood samples or cannot participate in follow-up
  2. Patient with end stage organ failure
  3. Kidney: creatinine >350 μmol/L or Estimated GFR ≤15 ml/min
  4. Liver dysfunction: liver function test >2.5 times normal
  5. Lungs: pulmonary FEV1<50% predicted
  6. Patient requiring intubation
  7. Patient with an admission NTproBNP measurement of >30,000 pg/ml
  8. Patient listed for heart transplant, or admitted specifically for transplant workup
  9. Patient in cardiogenic shock
  10. 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
  11. Patient with conditions that will make it difficult to discharge from hospital such as a fall or waiting for a long term care bed
  12. 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
  13. Patient who has participated in another research trial involving an investigational product in the past 30 days

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

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