Improvement of Patients With Chronic Heart Failure Using NT-proBNP (EXIMPROVECHF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2009 by St. Michael's Hospital, Toronto
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00601679
First received: January 8, 2008
Last updated: December 28, 2012
Last verified: July 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improvement in Clinical Outcomes of Patients With Chronic Heart Failure Using Serial NT-proBNP Monitoring: The EX-IMPROVE-CHF Study

Resource links provided by NLM:


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: 400
Study Start Date: December 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NT-proBNP
Surveillance NT-proBNP levels disclosed to physicians
Other: NT-proBNP guided care
knowledge of NT-proBNP results
Other Name: NT-proBNP guided care
No Intervention: Usual Care
Surveillance NT-proBNP levels blinded

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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.ca
Contact: Carlos S Fernando, MD 416-864-6060 ext 2886 fernandoc@smh.ca

Locations
Canada, British Columbia
St. Paul's Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Parveen Sangha, MSc    604-682-2344 ext 63390    PSangha@providencehealth.bc.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.ca   
Contact: Carlos S Fernando, MD    416-864-6060 ext 2886    fernandoc@smh.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, Toronto
ClinicalTrials.gov Identifier: NCT00601679     History of Changes
Other Study ID Numbers: CAN0013
Study First Received: January 8, 2008
Last Updated: December 28, 2012
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014