The Early High Risk Period for Patients With Heart Failure

Heart Failure, Congestive Clinical Trial

Official title:

The Early High Risk Period for Patients With Incident Heart Failure: A Population Based Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00127322
• Other study ID #: 2003EP005B
• Secondary ID: PG/03/097
• Status: Active, not recruiting
• Phase: N/A
• First received: August 3, 2005
• Last updated: February 9, 2006
• Start date: January 2004
• Est. completion date: January 2006

Study information

• Verified date: February 2006
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of heart failure

Exclusion Criteria:

• Under age of 18 years

• Unable to give consent

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Locations

Country	Name	City	State
United Kingdom	The Conquest Hospital	Hastings
United Kingdom	Hillingdon Hospital, Pield Heath Road	London

Sponsors (2)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust	Imperial College London

Country where clinical trial is conducted

United Kingdom,