Heart Failure Clinical Trial
— ESSICOfficial title:
Development of Clinical Prediction Rules and Health Services Research in Patients With Heart Failure (Health Services Evaluation in Heart Failure-ESSIC)
Verified date | February 2019 |
Source | Hospital Galdakao-Usansolo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Objectives: Objective of this project are to create several clinical prediction rules (CPR)
to stratify patients into different prognostic levels: on arrival at the emergency room, at
hospital discharge, in the evolution at 90 days, and up to 1 year; for clinical parameters
(mortality, complications, readmissions) and the evolution of the patient health related
quality of life. Additional objectives include the analysis of equity in access, continuity
of care after discharge, costs, psychosocial support received, and variability in clinical
decisions and in the results obtained from inclusion in the study after the visit to the
emergency room until 1 year of follow-up. Methods: Prospective observational cohort study
with a one year follow-up. Multicenter and coordinated study with 9 hospital in Spain. This
project will include around 1000 patients diagnosed of heart failure who come to emergency
services of these hospitals, whether discharge home or admitted to the hospital. Multiple
parameters (about the process of care, clinical outcomes, and quality of life), will be
retrieved in the emergency room visits, admission, discharge and up to one year follow up
after discharge. This project bases its work in the large number of variables to be collected
and would not be viable with few centers, so centers from other communities will collaborate
providing more cases.
Statistical analysis using multivariate logistic regression models or Cox or general linear
models or multilevel analysis will derive the CPR in a subsample of the original sample which
will be validated in another different subsample.
Status | Completed |
Enrollment | 2218 |
Est. completion date | December 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: - Patients with a diagnosis of heart failure (code ICD-9-CM: 428.x, some of the 402.x) who come to hospital emergencies according to the definition, signs and symptoms used to diagnose the disease according to the clinical practice guide of the European Society of Cardiology (ESC) for the diagnosis and treatment of acute and chronic heart failure, such as, among others, lack of air or fatigue at rest or during exercise; signs of fluid retention, such as pulmonary congestion or swelling of the ankles, and objective evidence of a structural or functional cardiac disturbance at rest . - Patients over 18 years of age and belonging to the hospital's coverage area. - Patients who agree to participate and sign the informed consent. Exclusion criteria: - Patients who develop episode of HF during admission, if they have been admitted for another cause. - Patients transferred from other health centers, since study variables may be missing. - Cerebrovascular accident in the 4 weeks before admission. - Patients who do not wish to participate. - Terminal status that prevents them from participating in completing the questionnaires. - Impossibility to complete the questionnaires or with external help (reviewer, family, social) due to neurosensory, dementia or ignorance of the language. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Comarcal de Antequera | Antequera | |
Spain | Hospital Santa Marina | Bilbao | |
Spain | Hospital U Basurto | Bilbao | |
Spain | Hospital Universitario Donostia | Donostia/San Sebastian | |
Spain | Hospital Galdakao-Usansolo | Galdakao | |
Spain | Hospital de Bellvitge | Hospitalet de Llobregat | |
Spain | Hospital Costa del Sol | Marbella | |
Spain | Hospital Universitari Parc Taulí | Sabadell | |
Spain | Hospital Universitario de Canarias | Tenerife |
Lead Sponsor | Collaborator |
---|---|
Hospital Galdakao-Usansolo | Hospital Costa del Sol, Hospital de Antequera, Hospital de Basurto, Hospital Donostia, Hospital Parc Taulí, Sabadell, Hospital Santa Marina, Hospital Universitari de Bellvitge, Hospital Universitario de Canarias |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality | Mortality during hospital admission, or after discharge from the emergency room (ER), and until one year after the ER index visit | One year | |
Secondary | Readmission | Readmissions until one year after the hospital index admission | One year | |
Secondary | Complications | Complications during admission and until one year after the ER index visit (life threatening conditions: acute myocardial infarction, ventricular fibrillation, cardiogenic shock, cardiac arrest, intensive treatments: resuscitation-intubation or mechanical ventilation, cardiac compression, resuscitation, and defibrillation, and (2) treatment of reperfusion - CABG, percutaneous transluminal coronary angiography or intravenous thrombolysis; Other complications: cardiological, kidney, liver, thromboembolic, stroke, nosocomial infection, side effects or drug interactions) | One year |
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