NCT02353481

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
63,320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 2, 2015

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

February 3, 2015

Status Verified

February 1, 2015

Enrollment Period

2.9 years

First QC Date

January 28, 2015

Last Update Submit

February 2, 2015

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    1 year

Study Arms (1)

Heart Failure

All patients in the audit that meets the eligibility criteria

Other: Heart Failure Management

Interventions

Heart Failure ManagementOTHER
Heart Failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Unscheduled heart failure admissions in England and Wales are recorded in the National Heart Failure Audit. Therefore, patients with data in the audit will be eligible for inclusion if they meet the inclusion criteria listed below.

You may qualify if:

  • aged 18 and above
  • survived to discharge
  • have mortality status at 1 year post-discharge

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London

London, United Kingdom

Location

Related Publications (4)

  • 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. doi: 10.1093/eurheartj/ehi555. Epub 2005 Oct 11.

    PMID: 16219658BACKGROUND

  • 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. doi: 10.1016/j.ahj.2004.08.005.

    PMID: 15846257BACKGROUND

  • 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. doi: 10.1161/CIRCULATIONAHA.105.584102. Epub 2006 Mar 13.

    PMID: 16534009BACKGROUND

  • Pocock SJ, Ariti CA, McMurray JJ, Maggioni A, Kober 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.

    PMID: 23095984BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Information Analyst, University College London

Study Record Dates

First Submitted

January 28, 2015

First Posted

February 2, 2015

Study Start

April 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

February 3, 2015

Record last verified: 2015-02

Locations

GB(1)