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.

Condition
Heart Failure, Congestive

Further Study Details: 

Expected Total Enrollment:  450

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Clinical diagnosis of heart failure

Exclusion Criteria:

• Under age of 18 years
• Unable to give consent

Please refer to this study by ClinicalTrials.gov identifier  NCT00127322

Martin R Cowie, MD MRCP MSc      +442073518856    m.cowie@imperial.ac.uk
Paresh A Mehta, MBCHB MRCP      +442073518856    p.mehta@imperial.ac.uk

United Kingdom
      Hillingdon Hospital, Pield Heath Road, London,  UB8 3NN,  United Kingdom; Recruiting
      The Conquest Hospital, Hastings,  United Kingdom; Recruiting

Study chairs or principal investigators

Martin R Cowie, MD MRCP MSc,  Principal Investigator,  Imperial College London and Royal Brompton NHS Trust   
Paresh A Mehta, MBChB MRCP,  Principal Investigator,  Imperial College and Royal Brompton Trust   
Simon W Dubrey, MD MRCP,  Principal Investigator,  Hillingdon Hospital NHS Trust   
Hugh F McIntyre, MD FRCP,  Principal Investigator,  East Sussex Hospitals NHS trust   
David M Walker, MD FRCP,  Principal Investigator,  East Sussex Hospitals NHS trust   

Study ID Numbers:  2003EP005B; PG/03/097
Last Updated:  August 22, 2005
Record first received:  August 3, 2005
ClinicalTrials.gov Identifier:  NCT00127322
Health Authority: United Kingdom: National Health Service
ClinicalTrials.gov processed this record on 2005-08-23