The Early High Risk Period for Patients With Heart Failure

Status Active, not recruiting

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.

Clinical Trial Description

n/a

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00127322
Study type	Observational
Source	Royal Brompton & Harefield NHS Foundation Trust
Contact
Status	Active, not recruiting
Phase	N/A
Start date	January 2004
Completion date	January 2006

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01357850` - A Multi-center, Placebo-controlled Study to Evaluate the Safety of GSK716155 and Its Effects on Myocardial Metabolism, Myocardial Function, and Exercise Capacity in Patients With NYHA Class II/III Congestive Heart Failure	Phase 2
Recruiting	`NCT00532688` - N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure	Phase 2/Phase 3
Terminated	`NCT00383630` - Bone Marrow Cell Transplantation to Improve Heart Function in Individuals With End-Stage Heart Failure	Phase 2
Completed	`NCT00531661` - CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients	N/A
Terminated	`NCT00125437` - Larger Dose of Spironolactone for the Treatment of Patients With Nonischemic Cardiomyopathy	N/A
Completed	`NCT00159614` - Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With CHF and Renal Impairment	Phase 2
Completed	`NCT00241761` - Epidemiology of Depression and Heart Failure in Aging	N/A
Completed	`NCT00149435` - Cardiovascular Health Study (CHS) Events Follow-up Study
Terminated	`NCT00357591` - Randomized Trial for Patients With Chronic Heart Failure With Acute Decompensation	N/A
Completed	`NCT00202579` - Efficacy and Safety of Ivabradine in Severe Congestive Heart Failure	Phase 2
Completed	`NCT00094263` - Long-Term Predictors of Morbidity in Older Age	N/A
Completed	`NCT00048425` - Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure.	Phase 3
Completed	`NCT00530426` - Heart Failure Registry	Phase 4
Completed	`NCT00023556` - Genetic Architecture of Heart Disease in Rural Brazil	N/A
Terminated	`NCT00190359` - Growth Hormone and Heart Failure	N/A
Completed	`NCT00004562` - Occluded Artery Trial (OAT)	Phase 3
Completed	`NCT00005265` - Natural History of Coronary Heart Disease	N/A
Completed	`NCT02772068` - Hemodynamic Response to Exercise in HFpEF Patients After Upregulation of SERCA2a	Early Phase 1
Completed	`NCT02925546` - A Phase I Study to Assess the Pharmacokinetics of GSK2798745 Tablets	Phase 1
Completed	`NCT01074307` - A Prospective, Open-labeled, Multi-centric Trial in Subjects With Systolic Heart Failure to Evaluate Bisoprolol Treatment for the Effects on Surrogate Markers of Heart Failure in Korea	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.