Improvement of Patients With Chronic Heart Failure Using NT-proBNP
EXIMPROVECHF
Improvement in Clinical Outcomes of Patients With Chronic Heart Failure Using Serial NT-proBNP Monitoring: The EX-IMPROVE-CHF Study
1 other identifier
interventional
400
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2007
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 8, 2008
CompletedFirst Posted
Study publicly available on registry
January 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedOctober 14, 2015
October 1, 2015
8.5 years
January 8, 2008
October 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Heart failure hospitalization and death
2 years
Secondary Outcomes (1)
Time to hospitalization/admission to ED due to HF, total number of HF events, total number of hospitalizations for cardiovascular events, all-cause mortality, cardiovascular mortality, worsening in clinical status but not requiring hospital admission
2 years
Study Arms (2)
NT-proBNP
EXPERIMENTALSurveillance NT-proBNP levels disclosed to physicians. Intervention (e.g. Diuretic management) based on NT-proBNP results.
Usual Care
NO INTERVENTIONSurveillance NT-proBNP levels blinded. Intervention (e.g. Diuretic management) based on clinical judgments.
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years of age
- NYHA class II-IV heart failure
- Followed in a programmed heart failure (HF) management setting
You may not qualify if:
- Life expectancy \<1 year due to causes other than HF such as advanced cancer
- Any other conditions that may render the patient ineligible according to the investigator's judgment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Unity Health Torontolead
- Hoffmann-La Rochecollaborator
Study Sites (2)
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
St Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gordon W Moe, MD, FACC
Unity Health Toronto
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2008
First Posted
January 28, 2008
Study Start
December 1, 2007
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
October 14, 2015
Record last verified: 2015-10