Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
St. Michael's Hospital, Toronto Hoffmann-La Roche |
---|---|
Information provided by: | St. Michael's Hospital, Toronto |
ClinicalTrials.gov Identifier: | NCT00601679 |
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 |
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 |
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
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Principal Investigator: | Gordon W Moe, MD, FACC | St. Michael's Hospital, Toronto |
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 |
CHF treatment&prognosis,NT-proBNP testing. |
Heart Failure Heart Diseases |
Heart Failure Heart Diseases Cardiovascular Diseases |