Trial Information

Summary: Effect of NT-proBNP guided treatment of Chronic Heart Failure (PRIMA Study).

Status: No longer recruiting

Protocol Number: 2003 B131

Sponsor:

Company Division: Diagnostic

Official Scientific Title: Can pro-brain natriuretic peptide guided therapy of chronic heart failure improve heart failure morbidity and mortality?

Brief Summary: This study will determine whether NT-proBNP guided treatment of chronic congestive heart failure to an individually pre-defined target value will reduce heart failure-related morbidity and mortality compared to therapy guided by standard clinical judgement.

Study Phase: N/A

Study Design / Study Details:

  • Purpose:
  • Allocation: Randomized
  • Masking: Open Label
  • Control:
  • Assignment: Parallel
  • Endpoints:

Study Type:

Interventional

Condition: Congestive Heart Failure

Intervention Type: Diagnostic Test

Intervention Name: ELECSYS®proBNP

Primary Outcome:

Key Secondary Outcomes:

Inclusion Criteria:

  • adult patients, ≥18 years of age;
  • hospital admission for congestive heart failure;
  • elevated NT-proBNP levels on admission.

Exclusion Criteria:

  • life-threatening cardiac arrhythmias;
  • severe lung disease;
  • patients undergoing hemodialysis or CAPD;
  • urgent intervention;
  • presence of life-threatening disease.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: May, 2004

Trial Registration Date: 08/22/2007

Date Last Updated: 02/07/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Rotterdam, Netherlands, 3075 AE
Telephone: 973-235-5000 or 800-526-6367

 

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Trial listings updated: November 17, 2008 at 2:37:15 PM


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