The Early High Risk Period for Patients With Heart Failure
|ClinicalTrials.gov Identifier: NCT00127322|
Recruitment Status : Unknown
Verified February 2006 by Royal Brompton & Harefield NHS Foundation Trust.
Recruitment status was: Active, not recruiting
First Posted : August 5, 2005
Last Update Posted : February 13, 2006
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.
- The high mortality and hospitalisation rate in the early period after diagnosis of heart failure is related to progressive pump failure; or
- 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 or disease|
|Heart Failure, Congestive|
|Study Type :||Observational|
|Enrollment :||450 participants|
|Observational Model:||Defined Population|
|Observational Model:||Natural History|
|Official Title:||The Early High Risk Period for Patients With Incident Heart Failure: A Population Based Study|
|Study Start Date :||January 2004|
|Study Completion Date :||January 2006|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00127322
|The Conquest Hospital|
|Hastings, United Kingdom|
|Hillingdon Hospital, Pield Heath Road|
|London, United Kingdom, UB8 3NN|
|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|