The Early High Risk Period for Patients With Heart Failure

• Conditions: Heart Failure, Congestive

• Registration Number: NCT00127322
• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust

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. 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

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-08-03
• Study First Submitted QC: 2005-08-03
• Study First Posted: 2005-08-05
• Study Completion: 2006-01
• Status Verified: 2006-02
• Last Update Submitted: 2006-02-09
• Last Update Posted: 2006-02-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Clinical diagnosis of heart failure

Exclusion Criteria

• Under age of 18 years
• Unable to give consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

The Conquest Hospital; 🇬🇧 Hastings, United Kingdom

Hillingdon Hospital, Pield Heath Road; 🇬🇧 London, United Kingdom