American Registry of Ambulatory or Acutely Decompensated Heart Failure (AMERICCAASS)

April 9, 2025 updated by: Juan Esteban Gomez, Fundacion Clinica Valle del Lili
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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

6732

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1617
        • Sanatorio Santa Clara Talar
      • Buenos Aires, Argentina
        • Hospital General de Agudos Carlos G. Durand
      • Corrientes, Argentina, 3400
        • Instituto de Cardiología Juana Francisca Cabral Bolívar
      • Córdoba, Argentina, 5000
        • Hospital Privado Universitario de Cordoba
      • Córdoba, Argentina
        • Hospital Italiano de Córdoba
      • Córdoba, Argentina
        • Instituto Modelo de Cardiología Privado SRL
      • Formosa, Argentina, 3600
        • Clinica Vrsalovic / Clinica del Angelo
      • Salta, Argentina, 4400
        • Hospital San Bernardo
      • San Juan, Argentina, 5400
        • Clínica El Castaño - CIMAC
      • San Juan, Argentina
        • Hospital Descentralizado Dr. Guillermo Rawson
      • San Juan, Argentina
        • Hospital Público Dr. Marcial V. Quiroga
      • San Luis, Argentina
        • Clínica CERHU / Hospital Central Ramón Carrillo
    • Buenos Aires
      • Quilmes, Buenos Aires, Argentina, 1878
        • Sanatorio Modelo Quilmes
      • Quilmes, Buenos Aires, Argentina
        • Sanatorio de la Trinidad Quilmes y Centro Gallego
    • La Pampa
      • Santa Rosa, La Pampa, Argentina, 6300
        • Establecimiento Asistencial Gobernador Centeno
    • Santa Fé
      • Rosario, Santa Fé, Argentina, 2000
        • Instituto Cardiovascular del Rosario
  • Bolivia
      • Santa Cruz de la Sierra, Bolivia
        • Caja Petrolera de Salud
    • Santa Cruz
      • Santa Cruz de la Sierra, Santa Cruz, Bolivia
        • Hospital Universitario Japonés
  • Chile
      • Santiago, Chile
        • Instituto Nacional del tórax
  • Colombia
      • Barranquilla, Colombia
        • Clínica General del Norte
      • Bogotá, Colombia
        • Hospital Santa Clara
      • Villavicencio, Colombia
        • Sociedad Cardiológica Colombiana S.A.S.
    • Antioquia
      • Medellín, Antioquia, Colombia, 050001
        • Clinica Cardio VID
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 08000
        • Sociedad Clínica Iberoamericana
    • Caldas
      • Manizales, Caldas, Colombia, 170002
        • Instituto Todo Por El Corazón
    • Caquetá
      • Florencia, Caquetá, Colombia, 180001-180009
        • Clínica Medilaser Florencia
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia, 110851
        • Clinica del Occidente
      • Bogotá, Cundinamarca, Colombia, 110911
        • Fundacion Cardioinfantil
      • Bogotá, Cundinamarca, Colombia, 110911
        • Fundacion Santa Fe de Bogota
    • Córdoba
      • Montería, Córdoba, Colombia
        • Hospicardio
    • Magdalena
      • Santa Marta, Magdalena, Colombia, 470001
        • Instituto Grupsalud
    • Nariño
      • Pasto, Nariño, Colombia
        • Unimedic Ips
    • Risaralda
      • Pereira, Risaralda, Colombia, 660003
        • Clínica los Rosales S.A. - Centro Médico para el Corazón
    • Santander
      • Floridablanca, Santander, Colombia
        • Fundacion Cardiovascular de Colombia
    • Tolima
      • Ibagué, Tolima, Colombia, 730001
        • Clinica Avidanti S.A.S
    • Valle
      • Santiago de Cali, Valle, Colombia, 760032
        • Fundación Valle Del Lili
  • Costa Rica
      • Heredia, Costa Rica, 40103
        • Hospital San Vicente de Paul
      • San José, Costa Rica, 10102
        • Hospital Clínica Bíblica
      • San José, Costa Rica, 10102
        • Hospital México, CCSS
  • Cuba
      • Bayamo, Cuba
        • Hospital Provincial Clínico Quirúrgico Docente Carlos Manuel De Céspedes
      • Camagüey, Cuba
        • Hospital Provincial Clínico Quirúrgico Docente Manuel Ascunce Domenech
      • Ciego De Ávila, Cuba
        • Hospital Provincial Dr. Antonio Luaces Iraola
      • Contramaestre, Cuba
        • Hospital General Orlando Pantoja Tamayo
      • La Habana, Cuba
        • Hospital Clínico Quirúrgico Docente Calixto García Íñiguez
      • La Habana, Cuba
        • Hospital Clínico Quirúrgico Docente Dr. Enrique Cabrera
      • La Habana, Cuba
        • Hospital Provincial Camilo Cienfuegos
      • Las Tunas, Cuba
        • Hospital General Docente Dr. Ernesto Guevara De La Serna
      • Matanzas, Cuba
        • Hospital Provincial Clínico Quirúrgico Docente Cmte. Faustino Pérez
      • Nueva Gerona, Cuba
        • Hospital Clínico Quirúrgico Docente Héroes Del Baire
      • Nuevitas, Cuba
        • Hospital Provincial Docente Marting Chang Puga
      • Pinar Del Río, Cuba
        • Hospital Provincial Clínico Quirúrgico Docente Abel Santamaría
      • Pinar del Rio, Cuba, 20100
        • Hospital Provincial Clinico Quirurgico Docente Leon Cuervo Rubio
      • Santiago de Cuba, Cuba
        • Cardiocentro Santiago de Cuba
      • Santiago de Cuba, Cuba
        • Hospital Provincial Saturnino Lora
    • Artemisa
      • San Antonio de los Baños, Artemisa, Cuba, 32700
        • Hospital Clinico Quirurgico Docente Ivan Portuondo
    • Departamento Occidental
      • La Habana, Departamento Occidental, Cuba, 10000-19999
        • Instituto de Cardiología y Cirugía Cardiovascular
  • Dominican Republic
      • San Francisco de Macoris, Dominican Republic
        • Centro Médico Siglo 21
      • Santiago De Los Caballeros, Dominican Republic
        • Hospital Metropolitano de Santiago Homs
    • Santiago
      • Santiago De Los Caballeros, Santiago, Dominican Republic, 51000
        • Clínica Universitaria Unión Médica del Norte
      • Santiago De Los Caballeros, Santiago, Dominican Republic, 51000
        • Hospital Regional Presidente Estrella Ureña
  • Ecuador
      • Cuenca, Ecuador
        • Hospital José Carrasco Arteaga / Instituto ecuatoriano de seguridad social
      • Machala, Ecuador
        • Clinica Jesús De Nazareth / Hospital San Marcos
      • Portoviejo, Ecuador
        • Hospital General EISS Portoviejo
      • Samborondón, Ecuador
        • Centro De Diagnóstico Y Tratamiento De Enfermedades (Cdt) Cardiovasculares Cardioheredia
    • Guayas
      • Guayaquil, Guayas, Ecuador, 090101 - 090158
        • Hospital Luis Vernaza
      • Guayaquil, Guayas, Ecuador, 090512
        • Hospital Clínica Kennedy
    • Manabí
      • Manta, Manabí, Ecuador, EC130850
        • Centro Médico de Especialidades Ameds
      • Manta, Manabí, Ecuador, EC130850
        • HOSPICOR
      • Portoviejo, Manabí, Ecuador, EC130150
        • Centro Cardiológico A.C.I
    • Pichincha
      • Quito, Pichincha, Ecuador, 170521
        • Hospital Metropolitano
  • El Salvador
      • San Salvador, El Salvador
        • Clínica de Cardiología y Ortopedia CCO
      • San Salvador, El Salvador
        • Clínica del Corazón Sinusal
      • San Salvador, El Salvador
        • Instituto Salvadoreño del Seguro Social
  • Guatemala
      • Chimaltenango, Guatemala, 04001
        • Cardiocentro Chimaltenango
      • Ciudad de Guatemala, Guatemala, 1001 - 1073
        • Hospital General San Juan de Dios
      • Ciudad de Guatemala, Guatemala, 1001 - 1073
        • Hospital Roosevelt
      • Quetzaltenango, Guatemala, 09001
        • Clínicas HART y Hospital Regional de Occidente
      • Zacapa, Guatemala, 19001
        • Hospital Regional de Zacapa
  • Honduras
    • Francisco Morazán
      • Tegucigalpa, Francisco Morazán, Honduras, 11101
        • Cardio Medical Center
      • Tegucigalpa, Francisco Morazán, Honduras, 11101
        • Instituto Nacional Cardiopulmonar
  • Jamaica
      • Kingston, Jamaica
        • Heart institute of the caribbean
  • Mexico
      • Aguascalientes, Mexico, 20000 - 20999
        • Centenario Hospital Miguel Hidalgo
      • Ciudad de México, Mexico, 01000-16999
        • Hospital Español. Sociedad de Beneficencia Española I.A.P
      • Ciudad de México, Mexico, 14080
        • Instituto Nacional de Cardiologia Ignacio Chavez
      • Ciudad de México, Mexico, 14080
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
      • Ciudad de México, Mexico
        • Servicios Profesionales Del Sagrado Corazón De Jesús S.C.
      • Monterrey, Mexico
        • TecSalud, Escuela de Medicina y Ciencias de la Salud del ITESM
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64000
        • Christus Muguerza Hospital Alta Especialidad
  • Nicaragua
      • Managua, Nicaragua
        • Hospital Carlos R Huembes/Clinica Plaza España/Clinica Centro Medico Juigalpa
  • Panama
      • Ciudad de Panamá, Panama
        • Hospital Santo Tomas
  • Paraguay
      • Asunción, Paraguay
        • Sanatorio Italiano
      • Asunción, Paraguay, 1001-1925
        • Hospital Central - Instituto de Previsión Social
      • Asunción, Paraguay, 1001-1925
        • Instituto Nacional de Cardiología "Prof. Dr. Juan A. Catonni"
      • Asunción, Paraguay
        • Instituto Cardiovascular del Sanatorio Migone
      • Asunción, Paraguay
        • Sanatorio Adventista de Asunción
      • Concepción, Paraguay
        • Clinicor Estudios Cardiológicos
      • San Lorenzo, Paraguay
        • Hospital de Clínicas - Facultad de ciencias médicas
    • Central
      • Itauguá, Central, Paraguay, 2740
        • Hospital Nacional de Itaugua
  • Peru
      • Chiclayo, Peru
        • Luis Heysen Inchaustegui - ESSALUD
      • Lima, Peru
        • Hospital Nacional Arzobispo Loayza
      • Lima, Peru, 15056
        • Hospital Maria Auxiliadora
      • Lima, Peru
        • Hospital Nacional Daniel Alcides Carrión
      • Lima, Peru
        • Instituto Cardiovascular Clinicor Norte
    • Áncash
      • Chimbote, Áncash, Peru
        • Hospital III EsSalud Chimbote
  • Suriname
      • Paramaribo, Suriname
        • Thorax Centrum Paramaribo /Academic Hospital Paramaribo
  • United States
    • New York
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital, Nothwell Health
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
  • Uruguay
      • Montevideo, Uruguay, 11000
        • Hospital de Clínicas Doctor Manuel Quintela
      • Montevideo, Uruguay
        • Médica Uruguaya
  • Venezuela
      • Anzoátegui, Venezuela
        • Cardiología Tropical Azoátegui
      • Cumaná, Venezuela
        • Atimed C.A
      • Mérida, Venezuela, 5101
        • Instituto Autónomo Hospital Universitario de Los Andes
      • Punto Fijo, Venezuela
        • IVSS Hospital Dr. Rafael Calles Sierra
      • Valencia, Venezuela
        • Unicor/Funvic
    • Bolívar
      • Puerto Ordaz, Bolívar, Venezuela, 8050
        • Clínica Chilemex
    • Carabobo
      • Puerto Cabello, Carabobo, Venezuela
        • Unidad Cardiovascular Ferrer
      • Valencia, Carabobo, Venezuela, 2001
        • Centro Policlínico Valencia
    • Lara
      • Barquisimeto, Lara, Venezuela, 3001
        • ASCARDIO
    • Sucre
      • Cumaná, Sucre, Venezuela, 6101
        • Centro Clinico Santa Rosa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Heart failure patients with either ambulatory diagnosis or an acute decompensation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outpatient management of heart failure
Time Frame: Baseline and at Month 12
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
Time Frame: Baseline and at Month 12
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
Time Frame: Baseline
Describe the clinical and hemodynamic presentation of patients with acute decompensated heart failure
Baseline
In-hospital management of acutely decompensated heart failure
Time Frame: Baseline
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
Time Frame: Baseline
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
Time Frame: Month 1, Month 6 and Month 12
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
Time Frame: Month 1, Month 6 and Month 12
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
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.
Baseline, Month 1, Month 6 and Month 12
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.
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
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.
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
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.
Month 1, Month 6 and Month 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
Baseline
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
Baseline
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
Baseline, Month 1, Month 6 and Month 12
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
Baseline, Month 1, Month 6 and Month 12
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
Baseline, Month 1, Month 6 and Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Clinica Valle del Lili

Collaborators

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

Investigators

  • Principal Investigator: Juan E Gomez-Mesa, MD, Fundacion Clinica Valle del Lili
  • Principal Investigator: Mario Speranza, MD, Hospital Clínica Bíblica
  • Principal Investigator: Eduardo R. Perna, MD, Instituto De Cardiología J. F. Cabral
  • Principal Investigator: Víctor A. Rossel, MD, Instituto Nacional del tórax
  • Principal Investigator: Daniel Quesada, MD, Hospital San Vicente de Paul
  • Principal Investigator: Mark H. Drazner, MD, University of Texas Southwestern Medical Center
  • Principal Investigator: Alexander Romero, MD, Hospital Santo Tomas
  • Principal Investigator: Walter Alarco, MD, Instituto Nacional Cardiovascular INCOR
  • Principal Investigator: Sebastian Seni-Molina, MD, Fundación Valle del Lili - Registry Coordinator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

January 31, 2025

Study Completion (Actual)

January 31, 2025

Study Registration Dates

First Submitted

March 15, 2022

First Submitted That Met QC Criteria

March 15, 2022

First Posted (Actual)

March 25, 2022

Study Record Updates

Last Update Posted (Actual)

April 13, 2025

Last Update Submitted That Met QC Criteria

April 9, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FVL-1310

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan to share IPD, since we are not allowed to share information concerning medical history of our patients

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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