Overview

This trial is active, not recruiting.

Condition heart failure, congestive
Sponsor Royal Brompton & Harefield NHS Foundation Trust
Collaborator Imperial College London
Start date January 2004
End date January 2006
Trial size 450 participants
Trial identifier NCT00127322, 2003EP005B, PG/03/097

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model defined population
Time perspective longitudinal

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Clinical diagnosis of heart failure Exclusion Criteria: - Under age of 18 years - Unable to give consent

Additional Information

Official title The Early High Risk Period for Patients With Incident Heart Failure: A Population Based Study
Principal investigator Martin R Cowie, MD MRCP MSc
Trial information was received from ClinicalTrials.gov and was last updated in February 2006.
Information provided to ClinicalTrials.gov by Royal Brompton & Harefield NHS Foundation Trust.