Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127322
Status:
UNKNOWN
Last Update Posted:
2006-02-13
First Post:
2005-08-03
Brief Title:
The Early High Risk Period for Patients With Heart Failure
Sponsor:
Royal Brompton Harefield NHS Foundation Trust
Organization:
Royal Brompton Harefield NHS Foundation Trust
Study Overview
Official Title:
The Early High Risk Period for Patients With Incident Heart Failure A Population Based Study
Status:
UNKNOWN
Status Verified Date:
2006-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PG03097 | None | None | None |