Effect of NT-proBNP Guided Treatment of Chronic Heart Failure

Study Overview
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Brief Summary
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The purpose of this study is to determine whether NT-proBNP guided treatment of chronic congestive heart failure will reduce heart failure related morbidity and mortality compared to therapy guided by standard clinical judgement.

Official Title
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Can Pro-brain-natriuretic Peptide Guided Therapy of Chronic Heart Failure Improve Heart Failure Morbidity and Mortality?

Conditions
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Heart Failure, Congestive

Intervention / Treatment
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* Device: NT-proBNP measurements


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admission because of congestive heart failure Elevated NT-proBNP levels on admission Exclusion Criteria: Life-threatening cardiac arrhythmias Urgent intervention Severe lung disease Presence of life threatening disease Signed informed consent for other study Mental or physical status not allowing written informed consent. Unwillingness to give informed consent Patients undergoing haemodialysis or continuous ambulatory peritoneal dialysis (CAPD)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NT-proBNP guided treatment group<br>In this group, management was guided by an individually set NT-proBNP, defined by the lowest level at discharge or 2 weeks thereafter. If NT-proBNP levels were elevated above the individually set NT-proBNP interventions were performed according to the ESC heart failure guidelines. | Device: NT-proBNP measurements<br> <br> |
| Placebo Comparator: Clinically guided arm<br>Heart failure treatment guided by clinical assessment. | Device: NT-proBNP measurements<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in total number of days alive and outside the hospital between the NT-proBNP guided and the clinical guided group. |  | minimum of one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | at least one year | 
| Cardiovascular mortality |  | at least one year | 
| All cause hospitalization |  | at least one year | 
| Cardiovascular related hospitalization |  | at least one year | 
| Total number of hospitalizations and mortality |  | at least one year | 
| Total number of cardiovascular hospitalizations and mortality |  | at least one year | 
| Differences in primary and secondary outcome measures among renal function and age subgroups |  | At least one year | 
| Differences in evidence based heart failure medication prescription after 3, 6 and 12 months |  | At least one year | 
| Analysis of major endpoints in patients where NT-proBNP levels were at or below the individual target level in at least 75% of all outpatient visits |  | at least one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NT-proBNP