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Development of Clinical Prediction Rules and Health Services Research in Patients With Heart Failure (ESSIC)

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ClinicalTrials.gov Identifier: NCT03512704
Recruitment Status : Completed
First Posted : May 1, 2018
Last Update Posted : February 5, 2019
Sponsor:
Collaborators:
Hospital de Basurto
Hospital Donostia
Hospital Costa del Sol
Hospital Universitari de Bellvitge
Hospital Parc Taulí, Sabadell
Hospital Universitario de Canarias
Hospital Santa Marina
Hospital de Antequera
Information provided by (Responsible Party):
JOSE M QUINTANA-LOPEZ, MD PhD, Hospital Galdakao-Usansolo

Brief Summary:

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.


Condition or disease Intervention/treatment
Heart Failure Other: Collection of possible predictors from patient data

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Study Type : Observational
Actual Enrollment : 2218 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of Clinical Prediction Rules and Health Services Research in Patients With Heart Failure (Health Services Evaluation in Heart Failure-ESSIC)
Actual Study Start Date : October 2013
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure


Intervention Details:
  • Other: Collection of possible predictors from patient data
    Collection of sociodemographic and clinical parameters, from medical records, and health related quality of life data, that may predict the outcomes of interest (mortality, complications, readmissions)


Primary Outcome Measures :
  1. Mortality [ Time Frame: One year ]
    Mortality during hospital admission, or after discharge from the emergency room (ER), and until one year after the ER index visit


Secondary Outcome Measures :
  1. Readmission [ Time Frame: One year ]
    Readmissions until one year after the hospital index admission

  2. Complications [ Time Frame: One year ]
    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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with known chronic heart failure (or de novo in the emergency department visit) attended in the emergency services of the participating hospitals prospectively diagnosed with acute or decompensated heart failure and recruited during the first year of the study, including patients admitted or given discharge in the hospital emergency. The first admission of each patient during the recruitment period will be taken as a reference, and after this episode the follow-up will be carried out during a whole year, collecting all the events that happen related to their illness.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03512704


Locations
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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, Spain
Sponsors and Collaborators
Hospital Galdakao-Usansolo
Hospital de Basurto
Hospital Donostia
Hospital Costa del Sol
Hospital Universitari de Bellvitge
Hospital Parc Taulí, Sabadell
Hospital Universitario de Canarias
Hospital Santa Marina
Hospital de Antequera
Investigators
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Principal Investigator: Jose M Quintana, MD, PhD Chief of Research Unit
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Responsible Party: JOSE M QUINTANA-LOPEZ, MD PhD, Chief of Research Unit, Hospital Galdakao-Usansolo
ClinicalTrials.gov Identifier: NCT03512704    
Other Study ID Numbers: PI12/01671
2013111071 ( Other Grant/Funding Number: Departamento de Sanidad del Gobierno Vasco )
PI13/02230 ( Other Grant/Funding Number: Instituto de Salud Carlos III )
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by JOSE M QUINTANA-LOPEZ, MD PhD, Hospital Galdakao-Usansolo:
Heart failure
clinical prediction rules
health services research
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases