American Registry of Ambulatory or Acutely Decompensated Heart Failure

Completed

• Conditions: Acute Heart Failure (AHF); Heart Failure; Chronic Heart Failure

• Registration Number: NCT05295641
• Lead Sponsor: Fundacion Clinica Valle del Lili

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-03-15
• Study First Posted: 2022-03-25
• Study Start: 2022-04-01
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6732

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characteristics of population with diagnosis of heart failure in America	Baseline, at Month 1, Month 6 and Month 12	Clinical and paraclinical characteristics of patients with heart failure

Secondary Outcome Measures

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

Trial Locations

Locations (119)

North Shore University Hospital, Nothwell Health; 🇺🇸 Manhasset, New York, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Sanatorio Modelo Quilmes; 🇦🇷 Quilmes, Buenos Aires, Argentina

Sanatorio de la Trinidad Quilmes y Centro Gallego; 🇦🇷 Quilmes, Buenos Aires, Argentina

Establecimiento Asistencial Gobernador Centeno; 🇦🇷 Santa Rosa, La Pampa, Argentina

Instituto Cardiovascular del Rosario; 🇦🇷 Rosario, Santa Fé, Argentina

Sanatorio Santa Clara Talar; 🇦🇷 Buenos Aires, Argentina

Hospital General de Agudos Carlos G. Durand; 🇦🇷 Buenos Aires, Argentina

Instituto de Cardiología Juana Francisca Cabral Bolívar; 🇦🇷 Corrientes, Argentina

Hospital Privado Universitario de Córdoba; 🇦🇷 Córdoba, Argentina

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