Clinical trial NCT00127322: The Early High Risk Period for Patients With Heart Failure
Official title: The Early High Risk Period for Patients With Incident Heart Failure: A Population Based Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure, Congestive
Keywords: Heart Failure, Congestive
survival
patient admission
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Imperial College London
First posted: 2005-08-05
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

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.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of heart failure

Exclusion Criteria:

* Under age of 18 years
* Unable to give consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hastings
country: United Kingdom
facility: The Conquest Hospital
city: London
country: United Kingdom
facility: Hillingdon Hospital, Pield Heath Road
Study officials:
affiliation: Imperial College London and Royal Brompton NHS Trust
name: Martin R Cowie, MD MRCP MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College and Royal Brompton Trust
name: Paresh A Mehta, MBChB MRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hillingdon Hospitals NHS Foundation Trust
name: Simon W Dubrey, MD MRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: East Sussex Hospitals NHS Trust
name: Hugh F McIntyre, MD FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: East Sussex Hospitals NHS Trust
name: David M Walker, MD FRCP
role: PRINCIPAL_INVESTIGATOR
References: