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The Early High Risk Period for Patients With Heart Failure

NCT ID: NCT00127322

Last Updated: 2006-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-01-31

Study Completion Date

2006-01-31

Brief Summary

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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. The high mortality and hospitalisation rate in the early period after diagnosis of heart failure is related to progressive pump failure; or
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.

This research should help to identify ways of improving the outlook for people with newly diagnosed heart failure. The analysis of the data generated by this study will be supervised by a statistician. Clinical and demographic data will be described using mean + standard deviation, for continuous variables, and absolute numbers and percentages for categorical variables. Group differences will be examined by t-tests for continuous variables and Chi-square (x2) test for categorical variables. Survival will be reported in terms of Kaplan-Meier curves with differences analysed by Cox proportional hazards.

Detailed Description

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Conditions

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Heart Failure, Congestive

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of heart failure

Exclusion Criteria

* Under age of 18 years
* Unable to give consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role collaborator

Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role lead

Principal Investigators

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Martin R Cowie, MD MRCP MSc

Role: PRINCIPAL_INVESTIGATOR

Imperial College London and Royal Brompton NHS Trust

Paresh A Mehta, MBChB MRCP

Role: PRINCIPAL_INVESTIGATOR

Imperial College and Royal Brompton Trust

Simon W Dubrey, MD MRCP

Role: PRINCIPAL_INVESTIGATOR

The Hillingdon Hospitals NHS Foundation Trust

Hugh F McIntyre, MD FRCP

Role: PRINCIPAL_INVESTIGATOR

East Sussex Hospitals NHS Trust

David M Walker, MD FRCP

Role: PRINCIPAL_INVESTIGATOR

East Sussex Hospitals NHS Trust

Locations

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The Conquest Hospital

Hastings, , United Kingdom

Site Status

Hillingdon Hospital, Pield Heath Road

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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PG/03/097

Identifier Type: -

Identifier Source: secondary_id

2003EP005B

Identifier Type: -

Identifier Source: org_study_id