Skip to main content
OpenTrials
Completed

NCT Number: NCT05295641

American Registry of Ambulatory or Acutely Decompensated Heart Failure

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sanatorio Modelo Quilmes, Quilmes, Buenos Aires, Argentina

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Primary outcomes

  1. Characteristics of population with diagnosis of heart failure in America

    Time frame: Baseline

    Sociodemographic characteristics of patients with heart failure

  2. Characteristics of population with diagnosis of heart failure in America

    Time frame: Baseline, at Month 1, Month 6 and Month 12

    Clinical and paraclinical characteristics of patients with heart failure

Secondary outcomes

  1. Outpatient management of heart failure

    Time frame: Baseline and at Month 12

    Describe the ambulatory/outpatient management of patients with heart failure

  2. Relation between outpatient treatment of heart failure with proportion of hospitalization and mortality

    Time frame: Baseline and at Month 12

    Relate outpatient pharmacological treatment with the proportion of hospitalization and mortality

  3. Clinical and hemodynamic presentation of acutely decompensated heart failure

    Time frame: Baseline

    Describe the clinical and hemodynamic presentation of patients with acute decompensated heart failure

  4. In-hospital management of acutely decompensated heart failure

    Time frame: Baseline

    Describe the in-hospital management of patients with acutely decompensated heart failure

  5. Proportion of in-hospital mortality related with acute decompensation of heart failure

    Time frame: Baseline

    Determine the proportion of in-hospital mortality related with acute decompensation of heart failure

  6. Proportion of rehospitalization at 1, 6, 12 months after hospital discharge

    Time frame: Month 1, Month 6 and Month 12

    Determine the proportion of rehospitalization at 1, 6 and 12 months after hospital discharge

  7. Proportion of mortality at 1, 6, 12 months after hospital discharge

    Time frame: Month 1, Month 6 and Month 12

    Determine the proportion of mortality at 1, 6 and 12 months after hospital discharge

  8. Relation between hemodynamic profile of decompensation with proportion of mortality at 1, 6, 12 months after hospital discharge

    Time frame: 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.

  9. Relation between in-hospital pharmacological treatment with mortality at 1, 6, 12 months after hospital discharge

    Time frame: 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.

  10. Relation between in-hospital pharmacological treatment with proportion of readmissions at 1, 6, 12 months after hospital discharge

    Time frame: 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.

  11. Relation between outpatient pharmacological treatment with proportion of hospitalization and mortality at 1, 6, 12 months after hospital discharge

    Time frame: 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.

  12. Differences among heart failure treatment considering sociodemographic characteristics

    Time frame: Baseline

    Describe the differences among inpatient and outpatient treatment taking into account different demographic characteristics such as: gender, age, comorbidities, among others

  13. Differences among proportion of rehospitalization and heart failure mortality considering sociodemographic characteristics

    Time frame: Baseline

    Describe the differences in the proportion of rehospitalization, hospital and outpatient mortality, taking into account different demographic characteristics: gender, age, comorbidities, among others

  14. Differences among proportion of rehospitalization and heart failure mortality considering implementation of optimal medical treatment

    Time frame: 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

  15. Differences among hospitalization and heart failure mortality considering the use of cardiac devices

    Time frame: 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

  16. Cumulative heart failure survival and readmission-free survival

    Time frame: Baseline, Month 1, Month 6 and Month 12

    Evaluate cumulative survival and heart failure readmission-free survival

Sponsors and collaborators

Lead sponsor

Fundacion Clinica Valle del Lili

Other

Collaborators

  • Consejo Interamericano de Falla Cardíaca e Hipertensión Pulmonar (CIFACAH)
  • Sociedad Interamericana de Cardiología (SIAC)

Registry information

Acronym: AMERICCAASS

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 25, 2022
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.