Trial Information

Summary: PROTECT Study: A Study of Pro-Brain Natriuretic Peptide (Pro-BNP) Targeted Therapy in Patients with Congestive Heart Failure (CHF) Followed as Outpatients.

Status: Recruiting

Protocol Number: 2003-18

Sponsor: Roche Diagnostics

Company Division: Diagnostic

Official Scientific Title:

Brief Summary: This study will evaluate the effect of standard of care plus proBNP compared with standard of care alone for evaluation and medical management of patients with CHF.

Study Phase: N/A

Study Design / Study Details:

  • Purpose:
  • Allocation:
  • Masking:
  • Control:
  • Assignment:
  • Endpoints:

Study Type:

Interventional

Condition: Congestive Heart Failure

Intervention Type: Diagnostic Test

Intervention Name: proBNP

Primary Outcome:

Key Secondary Outcomes:

Inclusion Criteria:

  • adult patients >=21 years of age;
  • heart failure;
  • hospital admission, emergency department visit, or outpatient treatment escalation for heart failure 6 months before enrollment.

Exclusion Criteria:

  • inoperable aortic valvular heart disease;
  • cardiac transplantation or revascularization indicated or expected within 6 months;
  • severe obstructive or restrictive pulmonary disease;
  • coronary revascularization (ie, percutaneous coronary intervention or coronary artery bypass surgery) within previous 3 months;
  • severe renal insufficiency.

Gender: Males or Females

Age Limits: Min: Years

Accepts Healthy Volunteers: No

Anticipated Start Date: October, 2005

Trial Registration Date: 06/24/2005

Date Last Updated: 05/07/2008

Link To Trial Results

Contact:

Research Site:
Located in:
Boston, MA 02114
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: November 17, 2008 at 2:22:53 PM


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