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Improvement of Patients With Chronic Heart Failure Using NT-proBNP (EXIMPROVECHF)
This study is currently recruiting participants.
Verified by St. Michael's Hospital, Toronto, November 2008
First Received: January 8, 2008   Last Updated: November 10, 2008   History of Changes
Sponsors and Collaborators: St. Michael's Hospital, Toronto
Hoffmann-La Roche
Information provided by: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT00601679
  Purpose

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.


Condition Intervention Phase
Congestive Heart Failure
Other: NT-proBNP guided care
Phase IV

MedlinePlus related topics: Heart Failure
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title: Improvement in Clinical Outcomes of Patients With Chronic Heart Failure Using Serial NT-proBNP Monitoring: The EX-IMPROVE-CHF Study

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Heart failure hospitalization and death [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1230
Study Start Date: December 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
NT-proBNP: Experimental
Surveillence NT-proBNP levels disclosed to physicians
Other: NT-proBNP guided care
knowledge of NT-proBNP results
Usual Care: No Intervention
Surveillance NT-proBNP levels blinded
Other: NT-proBNP guided care
knowledge of NT-proBNP results

Detailed Description:

Once an eligible clinic patient is identified, written informed consent will be obtained. All patients will have blood drawn for the measurement of NT-proBNP immediately after consent is obtained. The patient will then be randomized to either the usual care or NT-proBNP arm.

For each patient enrolled into the study the attending physician will ensure obligatory blood sampling for the measurement of NT-proBNP level every three months for a minimum of one year (4 samples). Conventional measures used in programmed management settings including history taking, physical and radiographic examination and echocardiography will also be undertaken as per clinical practice. Patients from both arms will be treated with the same conventional measures. 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 nurse practitioners. The other half (Usual Care) will have these values blinded. During the study, attending clinic physicians can order NT-proBNP or BNP assays, if available in their institution, to assist the management of their patients if they feel it is clinically needed. Demographic variables such as age, gender, BMI, serum creatinine, and eGFR will also be collected in both arms. A dedicated research coordinator based in St. Michael's Hospital, the core centre, will monitor patients, data and blood sample collection from all participating clinics. NT-proBNP will be measured on site in clinics with the facility to measure NT-proBNP. For clinics that do not have the facility, the samples will be shipped to the core centre for measurement and the results will be provided to the clinic within one week for those patients who are randomized to open-label NT-proBNP. The research coordinator, via close communications with the clinic nurses and physicians, will ensure the process is immaculately executed and blinding is maintained.

All patients will be followed every three months for a minimum of one year (4 samples) and will include an initial evaluation (Visit 1) along with four follow-up visits in the HF/heart functions clinics (Visits 2 - 5). A clinic visit will be requested for those patients having experienced a serious adverse event since Visit 1.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age ≥ 18 years of age
  • NYHA class II-IV heart failure
  • Followed in a programmed heart failure (HF) management setting

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00601679

Contacts
Contact: Gordon W Moe, MD, FACC 416-864-6060 ext 5319 moeg@smh.toronto.on.ca
Contact: Sandra Felix, BA 416-864-6060 ext 2886 felixs@smh.toronto.on.ca

Locations
Canada, British Columbia
St. Pauls Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Parveen Sangha, MSc     604-682-2344 ext 63390     psangha@providencehealth.bc.ca    
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Contact: Margo MacFarlane, BN, RN     (902)473-2728     Margo.MacFarlane@cdha.nshealth.ca    
Canada, Ontario
St Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Principal Investigator: Gordon W Moe, MD, FACC            
St Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Gordon W Moe, MD, FACC     416-864-6060 ext 5319     moeg@smh.toronto.on.ca    
Contact: Sandra Felix, BA     416-864-6060 ext 2886     felixs@smh.toronto.on.ca    
Principal Investigator: Gordon W Moe, MD, FACC            
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Hoffmann-La Roche
Investigators
Principal Investigator: Gordon W Moe, MD, FACC St. Michael's Hospital, Toronto
  More Information

No publications provided

Responsible Party: St Michael's Hospital ( Gordon W Moe, MD, FRCP(C), FACC )
Study ID Numbers: CAN0013
Study First Received: January 8, 2008
Last Updated: November 10, 2008
ClinicalTrials.gov Identifier: NCT00601679     History of Changes
Health Authority: Canada: Ethics Review Committee

Keywords provided by St. Michael's Hospital, Toronto:
CHF treatment&prognosis,NT-proBNP testing.

Study placed in the following topic categories:
Heart Failure
Heart Diseases

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 06, 2009