NCT00127322

Brief Summary

Many people with heart failure either die or are admitted to the hospital in the first few months after the condition is diagnosed. The reasons for this are currently unclear- but may be due to worsening heart failure or other medical conditions such as angina, heart attack or sudden electrical problems of the heart. The investigators propose to recruit and follow-up 450 people, with a new diagnosis of heart failure for a minimum of six months in a multi-centre observational study at two hospital sites: The Hillingdon (Uxbridge) and The Conquest (Hastings) hospitals. The total study duration will be two years. People will be recruited after a diagnosis of heart failure is made and the study will assess reasons for death or admission to hospital and the psychological impact of the condition on both patients and their carers. This is an observational study and no change will be made to patients' conventional treatment. Hypotheses:

  1. 1.The high mortality and hospitalisation rate in the early period after diagnosis of heart failure is related to progressive pump failure; or
  2. 2.The high mortality in the early period after the diagnosis of heart failure is related to co-morbid events- principally major coronary events such as myocardial infarction or acute coronary syndrome.

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
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2004

Geographic Reach
1 country

2 active sites

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

January 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

February 13, 2006

Status Verified

February 1, 2006

First QC Date

August 3, 2005

Last Update Submit

February 9, 2006

Conditions

Heart Failure, Congestive

Keywords

Heart Failure, Congestivesurvivalpatient admission

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of heart failure

You may not qualify if:

  • Under age of 18 years
  • Unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Conquest Hospital

Hastings, United Kingdom

Location

Hillingdon Hospital, Pield Heath Road

London, UB8 3NN, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Martin R Cowie, MD MRCP MSc

    Imperial College London and Royal Brompton NHS Trust

    PRINCIPAL INVESTIGATOR

  • Paresh A Mehta, MBChB MRCP

    Imperial College and Royal Brompton Trust

    PRINCIPAL INVESTIGATOR

  • Simon W Dubrey, MD MRCP

    The Hillingdon Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

  • Hugh F McIntyre, MD FRCP

    East Sussex Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

  • David M Walker, MD FRCP

    East Sussex Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 3, 2005

First Posted

August 5, 2005

Study Start

January 1, 2004

Study Completion

January 1, 2006

Last Updated

February 13, 2006

Record last verified: 2006-02

Locations

GB(2)