American Registry of Ambulatory or Acute Decompensated Heart Failure

Study Overview
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Brief Summary
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The purpose of this study is to better characterize and understand the population of patients with ambulatory or acutely decompensated heart failure in the American continent, getting to know their sociodemographic, clinical and paraclinical characteristics

Detailed Description
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An observational, prospective and multicenter study in which ambulatory patients with a confirmed diagnosis of heart failure and those admitted to the hospitalization service due to an episode of acutely decompensated heart failure will be invited to participate in order to better characterize this population Participants who meet the eligibility criteria will be evaluated at the moment of recruitment. Follow-ups will be performed at 1, 6 and 12 months after the initial registry for hospitalized patients. For ambulatory patients follow-up will only be performed at 12 months. These initial evaluations and subsequents follow-ups will be carried out using a standardized form for the collection of hospital and outpatient data through an electronic platform The purpose of this study is to know sociodemographic, clinical (clinical presentation, hemodynamic profiles, in-hospital and outpatient management, re-hospitalization rate, proportion of mortality, cumulative survival and heart failure readmission-free survival) and paraclinical characteristics of this population

Official Title
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American Registry of Ambulatory or Acute Decompensated Heart Failure

Conditions
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Heart Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged 18 years or older and one of the following: Hospitalized patient with admission diagnosis of acutely decompensated heart failure or Outpatient with confirmed diagnosis (main or complementary) of heart failure Exclusion Criteria: Hospitalized patient with principal diagnosis of another cardiovascular / non-cardiovascular pathology and who develops an acute decompensation of heart failure during hospitalization. Patient on heart transplant waiting list Patient who has implanted or is in process of implanting a long-term ventricular assist device (eg, Heart Mate II, Heart Mate III) as a target therapy or bridge therapy to other therapies Patient in whom palliative management has been previously defined for his/her cardiac condition (i.e. Heart failure) or for another associated medical condition (cancer, chronic obstructive pulmonary disease (COPD), etc.) Patient who is discharged or referred to another institution within 48 hours of hospital stay Inability to comply with programmed follow-ups (telephone or in person) due to social, personal or other conditions considered by the principal investigator Life expectancy less than 6 months given a condition other than heart failure (Cancer, COPD, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of population with diagnosis of heart failure in America | Sociodemographic characteristics of patients with heart failure | Baseline | 
| Characteristics of population with diagnosis of heart failure in America | Clinical and paraclinical characteristics of patients with heart failure | Baseline, at Month 1, Month 6 and Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outpatient management of heart failure | Describe the ambulatory/outpatient management of patients with heart failure | Baseline and at Month 12 | 
| Relation between outpatient treatment of heart failure with proportion of hospitalization and mortality | Relate outpatient pharmacological treatment with the proportion of hospitalization and mortality | Baseline and at Month 12 | 
| Clinical and hemodynamic presentation of acutely decompensated heart failure | Describe the clinical and hemodynamic presentation of patients with acute decompensated heart failure | Baseline | 
| In-hospital management of acutely decompensated heart failure | Describe the in-hospital management of patients with acutely decompensated heart failure | Baseline | 
| Proportion of in-hospital mortality related with acute decompensation of heart failure | Determine the proportion of in-hospital mortality related with acute decompensation of heart failure | Baseline | 
| Proportion of rehospitalization at 1, 6, 12 months after hospital discharge | Determine the proportion of rehospitalization at 1, 6 and 12 months after hospital discharge | Month 1, Month 6 and Month 12 | 
| Proportion of mortality at 1, 6, 12 months after hospital discharge | Determine the proportion of mortality at 1, 6 and 12 months after hospital discharge | Month 1, Month 6 and Month 12 | 
| Relation between hemodynamic profile of decompensation with proportion of mortality at 1, 6, 12 months after hospital discharge | Relate the hemodynamic profile of decompensation with the proportion of in-hospital and ambulatory mortality at 1, 6 and 12 months after hospital discharge. | Baseline, Month 1, Month 6 and Month 12 | 
| Relation between in-hospital pharmacological treatment with mortality at 1, 6, 12 months after hospital discharge | Relate hospital pharmacological treatment with inpatient and outpatient mortality at 1, 6 and 12 months after hospital discharge. | Month 1, Month 6 and Month 12 | 
| Relation between in-hospital pharmacological treatment with proportion of readmissions at 1, 6, 12 months after hospital discharge | Relate hospital pharmacological treatment with the proportion of readmissions at 1, 6 and 12 months after hospital discharge. | Month 1, Month 6 and Month 12 | 
| Relation between outpatient pharmacological treatment with proportion of hospitalization and mortality at 1, 6, 12 months after hospital discharge | Relate outpatient pharmacological treatment with the proportion of hospitalization and mortality at 1, 6 and 12 months after hospital discharge. | Month 1, Month 6 and Month 12 | 
| Differences among heart failure treatment considering sociodemographic characteristics | Describe the differences among inpatient and outpatient treatment taking into account different demographic characteristics such as: gender, age, comorbidities, among others | Baseline | 
| Differences among proportion of rehospitalization and heart failure mortality considering sociodemographic characteristics | Describe the differences in the proportion of rehospitalization, hospital and outpatient mortality, taking into account different demographic characteristics: gender, age, comorbidities, among others | Baseline | 
| Differences among proportion of rehospitalization and heart failure mortality considering implementation of optimal medical treatment | Describe the differences in the proportion of rehospitalization, hospital and outpatient mortality, taking into account the implementation of optimal or recommended medical treatment in national and international guidelines | Baseline, Month 1, Month 6 and Month 12 | 
| Differences among hospitalization and heart failure mortality considering the use of cardiac devices | Describe the differences between hospitalization and outpatient mortality taking into account the use of cardiac devices (cardiac resynchronization and/or implantable cardiac defibrillator) recommended in international guidelines | Baseline, Month 1, Month 6 and Month 12 | 
| Cumulative heart failure survival and readmission-free survival | Evaluate cumulative survival and heart failure readmission-free survival | Baseline, Month 1, Month 6 and Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Decompensated, Outpatient, Treatment, Hospitalization, Mortality