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Biomarker

NT-proBNP for Congestive Heart Failure (EXIMPROVECHF Trial)

Phase 4
Waitlist Available
Led By Gordon W Moe, MD, FACC
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group

Summary

This will be a multicentre Phase IV study in which patients with chronic HF who are managed and followed by HF/heart functions clinics will be followed over a period of two years. Clinic patients who are recruited into the study will have obligatory blood sampling for the surveillance measurement of NT-proBNP level every three months for a minimum of one year (4 samples). One-half of the subjects in each clinic will be randomized to have these NT-proBNP values made known to the attending clinic physicians and nurses, the other half will have these values blinded. During the study, attending clinic physicians can order open-label NT-proBNP or BNP assays, if available in their institution, to assist the management of their patients if they feel it is clinically needed.

Eligible Conditions
  • Congestive Heart Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: NT-proBNPExperimental Treatment1 Intervention
Surveillance NT-proBNP levels disclosed to physicians. Intervention (e.g. Diuretic management) based on NT-proBNP results.
Group II: Usual CareActive Control1 Intervention
Surveillance NT-proBNP levels blinded. Intervention (e.g. Diuretic management) based on clinical judgments.

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor
556 Previous Clinical Trials
454,006 Total Patients Enrolled
Hoffmann-La RocheIndustry Sponsor
2,452 Previous Clinical Trials
1,095,903 Total Patients Enrolled
Gordon W Moe, MD, FACCPrincipal InvestigatorUnity Health Toronto
~22 spots leftby Nov 2025