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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 3, 2005

Last Updated Date

February 9, 2006

Start Date ^ICMJE

January 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00127322 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Early High Risk Period for Patients With Heart Failure

Official Title ^ICMJE

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

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:

The high mortality and hospitalisation rate in the early period after diagnosis of heart failure is related to progressive pump failure; or
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 Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Heart Failure, Congestive

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

450

Completion Date

January 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Clinical diagnosis of heart failure

Exclusion Criteria:

Under age of 18 years
Unable to give consent

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00127322

Other Study ID Numbers ^ICMJE

2003EP005B, PG/03/097

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Royal Brompton & Harefield NHS Foundation Trust

Collaborators ^ICMJE

Imperial College London

Investigators ^ICMJE

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	Hillingdon Hospital NHS 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

Information Provided By

Royal Brompton & Harefield NHS Foundation Trust

Verification Date

February 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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