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American Registry of Ambulatory or Acutely Decompensated Heart Failure

American Registry of Ambulatory or Acutely Decompensated Heart Failure

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05295641
Acronym
AMERICCAASS
Enrollment
6732
Registered
2022-03-25
Start date
2022-04-01
Completion date
2025-01-31
Last updated
2025-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Heart Failure (AHF), Chronic Heart Failure, Heart Failure

Keywords

Decompensated, Outpatient, Treatment, Hospitalization, Mortality, Heart Failure, Americas, Registry, Inpatient

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

Interventions

None listed

Sponsors

Sociedad Interamericana de Cardiología (SIAC)
CollaboratorUNKNOWN
Consejo Interamericano de Falla Cardíaca e Hipertensión Pulmonar (CIFACAH)
CollaboratorUNKNOWN
Fundacion Clinica Valle del Lili
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
Characteristics of population with diagnosis of heart failure in AmericaBaselineSociodemographic characteristics of patients with heart failure

Secondary

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

Countries

Argentina, Bolivia, Chile, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Jamaica, Mexico, Nicaragua, Panama, Paraguay, Peru, Suriname, United States, Uruguay, Venezuela

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026