Improvement of Patients With Chronic Heart Failure Using NT-proBNP

NCT ID: NCT00601679

Last Updated: 2015-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2016-06-30

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.

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.

Conditions

Congestive Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

NT-proBNP

Surveillance NT-proBNP levels disclosed to physicians. Intervention (e.g. Diuretic management) based on NT-proBNP results.

Group Type: EXPERIMENTAL

NT-proBNP guided care

Intervention Type: OTHER

knowledge of NT-proBNP results

Usual Care

Surveillance NT-proBNP levels blinded. Intervention (e.g. Diuretic management) based on clinical judgments.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

NT-proBNP guided care

knowledge of NT-proBNP results

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gordon W Moe, MD, FACC

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

St. Paul's Hospital

Vancouver, British Columbia, Canada

St Michael's Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

CAN0013

Identifier Type: -

Identifier Source: org_study_id