The Early High Risk Period for Patients With Heart Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by Royal Brompton & Harefield NHS Foundation Trust.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Imperial College London
Information provided by:
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00127322
First received: August 3, 2005
Last updated: February 9, 2006
Last verified: February 2006
  Purpose

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.


Condition
Heart Failure, Congestive

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: The Early High Risk Period for Patients With Incident Heart Failure: A Population Based Study

Resource links provided by NLM:


Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

Estimated Enrollment: 450
Study Start Date: January 2004
Estimated Study Completion Date: January 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of heart failure

Exclusion Criteria:

  • Under age of 18 years
  • Unable to give consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127322

Locations
United Kingdom
The Conquest Hospital
Hastings, United Kingdom
Hillingdon Hospital, Pield Heath Road
London, United Kingdom, UB8 3NN
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Imperial College London
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00127322     History of Changes
Other Study ID Numbers: 2003EP005B, PG/03/097
Study First Received: August 3, 2005
Last Updated: February 9, 2006
Health Authority: United Kingdom: National Health Service

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Heart Failure, Congestive
survival
patient admission

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014