The Early High Risk Period for Patients With Heart Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by Royal Brompton & Harefield NHS Foundation Trust.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Imperial College London
Information provided by:
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00127322
First received: August 3, 2005
Last updated: February 9, 2006
Last verified: February 2006

August 3, 2005
February 9, 2006
January 2004
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Complete list of historical versions of study NCT00127322 on ClinicalTrials.gov Archive Site
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The Early High Risk Period for Patients With Heart Failure
The Early High Risk Period for Patients With Incident Heart Failure: A Population Based Study

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.

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Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
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Heart Failure, Congestive
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
450
January 2006
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Inclusion Criteria:

  • Clinical diagnosis of heart failure

Exclusion Criteria:

  • Under age of 18 years
  • Unable to give consent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00127322
2003EP005B, PG/03/097
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Royal Brompton & Harefield NHS Foundation Trust
Imperial College London
Principal Investigator: 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
Royal Brompton & Harefield NHS Foundation Trust
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP