NCT00498472

Brief Summary

Hospitalizations for acute heart failure syndromes (AHFS) are associated with a high rehospitalisation and mortality rate. The aim of this study is to assess if the measurement of NT-proBNP levels before discharge may improve the prognosis of the patients recently admitted to hospital for AHFS

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

June 15, 2010

Status Verified

July 1, 2007

Enrollment Period

3.8 years

First QC Date

July 9, 2007

Last Update Submit

June 14, 2010

Conditions

Acute Heart Failure

Keywords

BNPheart failure

Outcome Measures

Primary Outcomes (1)

  • Incidence of unplanned cardiovascular hospitalization and cardiac deaths at 6 months in the control and the intervention groups.

    30 months

Secondary Outcomes (3)

  • Cardiac mortality alone

    30 months

  • Combined end-point of cardiac deaths, cardiovascular hospitalizations; no. of days in hospital during follow-up

    30 months

  • Changes in LVEF, LV volumes, 6MWTD, NYHA class from discharge to 6 mts. f-up

    30 months

Study Arms (2)

A

ACTIVE COMPARATOR

Pre-discharge NT-ProBNP based

Procedure: Pre-discharge NT-ProBNP based treatment

B

NO INTERVENTION

Discharge date and treatment not based on the knowledge of pre-discharge NT-proBNP levels

Interventions

Pre-discharge NT-ProBNP based treatmentPROCEDURE

Discharge date, treatment and follow-up based also on the knowledge of NT-ProBNP levels measured at 2-3 days before discharge. Discharge may be postponed and medical treatment may be changed when NT-ProBNP is \>3000 pg/ml. Changes in medical treatment will include the following: increase in the diuretic dose, association of a different diuretic; combination of digoxin therapy; increase in the dose of the renin-angiotensin inhibitor; association of an ARB; association of a nitrate; short course of i.v. diuretic, vasodilator and/or inotropic therapy.

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted for acute HF with New York Heart Association class III or IV symptoms.
  • Requirement of intravenous therapy
  • All patients should give their written informed consent

You may not qualify if:

  • Clinical or laboratory evidence of an acute coronary syndrome
  • Major arrhythmias as main cause of symptoms
  • Patients in whom a coronary revascularization procedure (either PTCA or CABG) is planned in the next 3 months
  • Non cardiac concomitant diseases which may have an important influence on outcome as primary factor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiologia, University of Brescia c/o Spedali Civili P.zza Spedali Civili 1

Brescia, BS, 25123, Italy

Location

Related Publications (2)

  • Metra M, Nodari S, Parrinello G, Specchia C, Brentana L, Rocca P, Fracassi F, Bordonali T, Milani P, Danesi R, Verzura G, Chiari E, Dei Cas L. The role of plasma biomarkers in acute heart failure. Serial changes and independent prognostic value of NT-proBNP and cardiac troponin-T. Eur J Heart Fail. 2007 Aug;9(8):776-86. doi: 10.1016/j.ejheart.2007.05.007. Epub 2007 Jun 18.

    PMID: 17573240BACKGROUND

  • Bettencourt P, Azevedo A, Pimenta J, Frioes F, Ferreira S, Ferreira A. N-terminal-pro-brain natriuretic peptide predicts outcome after hospital discharge in heart failure patients. Circulation. 2004 Oct 12;110(15):2168-74. doi: 10.1161/01.CIR.0000144310.04433.BE. Epub 2004 Sep 27.

    PMID: 15451800BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Marco Metra, MD

    Section of Cardiovascular Disease, University of Brescia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 9, 2007

First Posted

July 10, 2007

Study Start

July 1, 2006

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

June 15, 2010

Record last verified: 2007-07

Locations

IT(1)