1 Year Post Discharge Prognostic Model From the National Heart Failure Audit (NHFA)

Heart Failure Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02353481
• Other study ID #: NICOR-Heart Failure
• Status: Active, not recruiting
• Phase: N/A
• First received: January 28, 2015
• Last updated: February 2, 2015
• Start date: April 2012
• Est. completion date: March 2015

Study information

• Verified date: February 2015
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Healthcare Quality Improvement Partnership
• Study type: Observational

Clinical Trial Summary

The aim of the study is to develop and assess a prognostic model for patient's survival up to 1 year after unscheduled acute heart failure hospital admission in England and Wales.

Description:

There is a need for a prognostic model for 1 year survival of patients discharged alive after an unscheduled hospital admission for heart failure. This study aims to develop and validate a prognostic model that will enable management planning and facilitate the identification of therapeutic needs or targets. Also, it will assist care providers to predict or quantify patients' survival based on their baseline characteristics.

The National Heart Failure Audit (NHFA) held by National Institute for Cardiovascular Outcomes Research (NICOR) is one of the largest available national heart failure registry. It includes data from unscheduled heart failure admissions in England and Wales. In the audit, heart failure diagnosis is defined as a diagnosis that has been confirmed by imaging or brain natriuretic peptide (BNP) measurement. This study will use NHFA data to develop and validate the proposed model.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 63320
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• aged 18 and above

• survived to discharge

• have mortality status at 1 year post-discharge

Exclusion Criteria:

Non-index heart failure admissions during the study period will be excluded from the study sample.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Heart Failure Management

Locations

Country	Name	City	State
United Kingdom	University College London	London

Sponsors (3)

Lead Sponsor	Collaborator
University College, London	British Society for Heart Failure, National Institute for Cardiovascular Outcomes Research

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

Adams KF Jr, Fonarow GC, Emerman CL, LeJemtel TH, Costanzo MR, Abraham WT, Berkowitz RL, Galvao M, Horton DP; ADHERE Scientific Advisory Committee and Investigators. Characteristics and outcomes of patients hospitalized for heart failure in the United States: rationale, design, and preliminary observations from the first 100,000 cases in the Acute Decompensated Heart Failure National Registry (ADHERE). Am Heart J. 2005 Feb;149(2):209-16. — View Citation

Levy WC, Mozaffarian D, Linker DT, Sutradhar SC, Anker SD, Cropp AB, Anand I, Maggioni A, Burton P, Sullivan MD, Pitt B, Poole-Wilson PA, Mann DL, Packer M. The Seattle Heart Failure Model: prediction of survival in heart failure. Circulation. 2006 Mar 21;113(11):1424-33. Epub 2006 Mar 13. — View Citation

Pocock SJ, Ariti CA, McMurray JJ, Maggioni A, Køber L, Squire IB, Swedberg K, Dobson J, Poppe KK, Whalley GA, Doughty RN; Meta-Analysis Global Group in Chronic Heart Failure. Predicting survival in heart failure: a risk score based on 39 372 patients from 30 studies. Eur Heart J. 2013 May;34(19):1404-13. doi: 10.1093/eurheartj/ehs337. Epub 2012 Oct 24. — View Citation

Pocock SJ, Wang D, Pfeffer MA, Yusuf S, McMurray JJ, Swedberg KB, Ostergren J, Michelson EL, Pieper KS, Granger CB. Predictors of mortality and morbidity in patients with chronic heart failure. Eur Heart J. 2006 Jan;27(1):65-75. Epub 2005 Oct 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality		1 year	No