Clinical trial NCT05295641: American Registry of Ambulatory or Acutely Decompensated Heart Failure
Official title: American Registry of Ambulatory or Acutely Decompensated Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Acute Heart Failure (AHF)
Chronic Heart Failure
Keywords: Decompensated
Outpatient
Treatment
Hospitalization
Mortality
Heart Failure
Americas
Registry
Inpatient
Lead sponsor: Fundacion Clinica Valle del Lili
Sponsor class: OTHER
Collaborators: name: Sociedad Interamericana de Cardiología (SIAC)
name: Consejo Interamericano de Falla Cardíaca e Hipertensión Pulmonar (CIFACAH)
First posted: 2022-03-25
Enrollment: 6732
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart failure patients with either ambulatory diagnosis or an acute decompensation

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

Eligibility criteria: 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.)

Primary outcomes:
measure: Characteristics of population with diagnosis of heart failure in America
timeFrame: Baseline
measure: Characteristics of population with diagnosis of heart failure in America
timeFrame: Baseline, at Month 1, Month 6 and Month 12
Secondary outcomes:
measure: Outpatient management of heart failure
timeFrame: Baseline and at Month 12
measure: Relation between outpatient treatment of heart failure with proportion of hospitalization and mortality
timeFrame: Baseline and at Month 12
measure: Clinical and hemodynamic presentation of acutely decompensated heart failure
timeFrame: Baseline
measure: In-hospital management of acutely decompensated heart failure
timeFrame: Baseline
measure: Proportion of in-hospital mortality related with acute decompensation of heart failure
timeFrame: Baseline
measure: Proportion of rehospitalization at 1, 6, 12 months after hospital discharge
timeFrame: Month 1, Month 6 and Month 12
measure: Proportion of mortality at 1, 6, 12 months after hospital discharge
timeFrame: Month 1, Month 6 and Month 12
measure: Relation between hemodynamic profile of decompensation with proportion of mortality at 1, 6, 12 months after hospital discharge
timeFrame: Baseline, Month 1, Month 6 and Month 12
measure: Relation between in-hospital pharmacological treatment with mortality at 1, 6, 12 months after hospital discharge
timeFrame: Month 1, Month 6 and Month 12
measure: Relation between in-hospital pharmacological treatment with proportion of readmissions at 1, 6, 12 months after hospital discharge
timeFrame: Month 1, Month 6 and Month 12
measure: Relation between outpatient pharmacological treatment with proportion of hospitalization and mortality at 1, 6, 12 months after hospital discharge
timeFrame: Month 1, Month 6 and Month 12
measure: Differences among heart failure treatment considering sociodemographic characteristics
timeFrame: Baseline
measure: Differences among proportion of rehospitalization and heart failure mortality considering sociodemographic characteristics
timeFrame: Baseline
measure: Differences among proportion of rehospitalization and heart failure mortality considering implementation of optimal medical treatment
timeFrame: Baseline, Month 1, Month 6 and Month 12
measure: Differences among hospitalization and heart failure mortality considering the use of cardiac devices
timeFrame: Baseline, Month 1, Month 6 and Month 12
measure: Cumulative heart failure survival and readmission-free survival
timeFrame: Baseline, Month 1, Month 6 and Month 12
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: North Shore University Hospital, Nothwell Health
state: New York
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Quilmes
country: Argentina
facility: Sanatorio Modelo Quilmes
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Sanatorio de la Trinidad Quilmes y Centro Gallego
state: Buenos Aires
city: Santa Rosa
country: Argentina
facility: Establecimiento Asistencial Gobernador Centeno
state: La Pampa
city: Rosario
country: Argentina
facility: Instituto Cardiovascular del Rosario
state: Santa Fé
city: Buenos Aires
country: Argentina
facility: Sanatorio Santa Clara Talar
city: Buenos Aires
country: Argentina
facility: Hospital General de Agudos Carlos G. Durand
city: Corrientes
country: Argentina
facility: Instituto de Cardiología Juana Francisca Cabral Bolívar
city: Córdoba
country: Argentina
facility: Hospital Privado Universitario de Córdoba
city: Córdoba
country: Argentina
facility: Hospital Italiano de Córdoba
city: Córdoba
country: Argentina
facility: Instituto Modelo de Cardiología Privado SRL
city: Formosa
country: Argentina
facility: Clinica Vrsalovic / Clinica del Angelo
city: Salta
country: Argentina
facility: Hospital San Bernardo
city: San Juan
country: Argentina
facility: Clínica El Castaño - CIMAC
city: San Juan
country: Argentina
facility: Hospital Descentralizado Dr. Guillermo Rawson
city: San Juan
country: Argentina
facility: Hospital Público Dr. Marcial V. Quiroga
city: San Luis
country: Argentina
facility: Clínica CERHU / Hospital Central Ramón Carrillo
city: Santa Cruz de la Sierra
country: Bolivia
facility: Hospital Universitario Japonés
state: Santa Cruz
city: Santa Cruz de la Sierra
country: Bolivia
facility: Caja Petrolera de Salud
city: Santiago
country: Chile
facility: Instituto Nacional del Tórax
city: Medellín
country: Colombia
facility: Clinica Cardio VID
state: Antioquia
city: Barranquilla
country: Colombia
facility: Sociedad Clínica Iberoamericana
state: Atlantico
city: Manizales
country: Colombia
facility: Instituto Todo Por El Corazón
state: Caldas
city: Florencia
country: Colombia
facility: Clínica Medilaser Florencia
state: Caquetá
city: Bogotá
country: Colombia
facility: Clínica del Occidente
state: Cundinamarca
city: Bogotá
country: Colombia
facility: Fundación Cardioinfantil
state: Cundinamarca
city: Bogotá
country: Colombia
facility: Fundación Santa Fé de Bogotá
state: Cundinamarca
city: Montería
country: Colombia
facility: Hospicardio
state: Córdoba
city: Santa Marta
country: Colombia
facility: Instituto Grupsalud
state: Magdalena
city: Pasto
country: Colombia
facility: Unimedic Ips
state: Nariño
city: Pereira
country: Colombia
facility: Clínica los Rosales S.A. - Centro Médico para el Corazón
state: Risaralda
city: Floridablanca
country: Colombia
facility: Fundación Cardiovascular de Colombia
state: Santander
city: Ibagué
country: Colombia
facility: Clinica Avidanti S.A.S
state: Tolima
city: Santiago de Cali
country: Colombia
facility: Fundación Valle del Lili
state: Valle
city: Barranquilla
country: Colombia
facility: Clínica General del Norte
city: Bogotá
country: Colombia
facility: Hospital Santa Clara
city: Villavicencio
country: Colombia
facility: Sociedad Cardiológica Colombiana S.A.S.
city: Heredia
country: Costa Rica
facility: Hospital San Vicente de Paúl
city: San José
country: Costa Rica
facility: Hospital Clínica Bíblica
city: San José
country: Costa Rica
facility: Hospital México, CCSS
city: San Antonio de los Baños
country: Cuba
facility: Hospital Clinico Quirurgico Docente Ivan Portuondo
state: Artemisa
city: La Habana
country: Cuba
facility: Instituto de Cardiología y Cirugía Cardiovascular
state: Departamento Occidental
city: Bayamo
country: Cuba
facility: Hospital Provincial Clínico Quirúrgico Docente Carlos Manuel De Céspedes
city: Camagüey
country: Cuba
facility: Hospital Provincial Clínico Quirúrgico Docente Manuel Ascunce Domenech
city: Ciego De Ávila
country: Cuba
facility: Hospital Provincial Dr. Antonio Luaces Iraola
city: Contramaestre
country: Cuba
facility: Hospital General Orlando Pantoja Tamayo
city: La Habana
country: Cuba
facility: Hospital Clínico Quirúrgico Docente Calixto García Íñiguez
city: La Habana
country: Cuba
facility: Hospital Clínico Quirúrgico Docente Dr. Enrique Cabrera
city: La Habana
country: Cuba
facility: Hospital Provincial Camilo Cienfuegos
city: Las Tunas
country: Cuba
facility: Hospital General Docente Dr. Ernesto Guevara De La Serna
city: Matanzas
country: Cuba
facility: Hospital Provincial Clínico Quirúrgico Docente Cmte. Faustino Pérez
city: Nueva Gerona
country: Cuba
facility: Hospital Clínico Quirúrgico Docente Héroes Del Baire
city: Nuevitas
country: Cuba
facility: Hospital Provincial Docente Marting Chang Puga
city: Pinar del Rio
country: Cuba
facility: Hospital Provincial Clinico Quirurgico Docente Leon Cuervo Rubio
city: Pinar Del Río
country: Cuba
facility: Hospital Provincial Clínico Quirúrgico Docente Abel Santamaría
city: Santiago de Cuba
country: Cuba
facility: Cardiocentro Santiago de Cuba
city: Santiago de Cuba
country: Cuba
facility: Hospital Provincial Saturnino Lora
city: Santiago De Los Caballeros
country: Dominican Republic
facility: Clínica Universitaria Unión Médica del Norte
state: Santiago
city: Santiago De Los Caballeros
country: Dominican Republic
facility: Hospital Regional Presidente Estrella Ureña
state: Santiago
city: San Francisco de Macoris
country: Dominican Republic
facility: Centro Médico Siglo 21
city: Santiago De Los Caballeros
country: Dominican Republic
facility: Hospital Metropolitano de Santiago Homs
city: Guayaquil
country: Ecuador
facility: Hospital Luis Vernaza
state: Guayas
city: Guayaquil
country: Ecuador
facility: Hospital Clínica Kennedy
state: Guayas
city: Manta
country: Ecuador
facility: Centro Médico de Especialidades Ameds
state: Manabí
city: Manta
country: Ecuador
facility: HOSPICOR
state: Manabí
city: Portoviejo
country: Ecuador
facility: Centro Cardiológico A.C.I
state: Manabí
city: Quito
country: Ecuador
facility: Hospital Metropolitano
state: Pichincha
city: Cuenca
country: Ecuador
facility: Hospital José Carrasco Arteaga / Instituto ecuatoriano de seguridad social
city: Machala
country: Ecuador
facility: Clinica Jesús De Nazareth / Hospital San Marcos
city: Portoviejo
country: Ecuador
facility: Hospital General EISS Portoviejo
city: Samborondón
country: Ecuador
facility: Centro De Diagnóstico Y Tratamiento De Enfermedades (Cdt) Cardiovasculares Cardioheredia
city: San Salvador
country: El Salvador
facility: Clínica de Cardiología y Ortopedia CCO
city: San Salvador
country: El Salvador
facility: Clínica del Corazón Sinusal
city: San Salvador
country: El Salvador
facility: Instituto Salvadoreño del Seguro Social
city: Chimaltenango
country: Guatemala
facility: Cardiocentro Chimaltenango
city: Ciudad de Guatemala
country: Guatemala
facility: Hospital General San Juan de Dios
city: Ciudad de Guatemala
country: Guatemala
facility: Hospital Roosevelt
city: Quetzaltenango
country: Guatemala
facility: Clínicas HART y Hospital Regional de Occidente
city: Zacapa
country: Guatemala
facility: Hospital Regional de Zacapa
city: Tegucigalpa
country: Honduras
facility: Cardio Medical Center
state: Francisco Morazán
city: Tegucigalpa
country: Honduras
facility: Instituto Nacional Cardiopulmonar
state: Francisco Morazán
city: Kingston
country: Jamaica
facility: Heart institute of the caribbean
city: Monterrey
country: Mexico
facility: Christus Muguerza Hospital Alta Especialidad
state: Nuevo León
city: Aguascalientes
country: Mexico
facility: Centenario Hospital Miguel Hidalgo
city: Ciudad de México
country: Mexico
facility: Hospital Español. Sociedad de Beneficencia Española I.A.P
city: Ciudad de México
country: Mexico
facility: Instituto Nacional de Cardiología Ignacio Chávez
city: Ciudad de México
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran
city: Ciudad de México
country: Mexico
facility: Servicios Profesionales Del Sagrado Corazón De Jesús S.C.
city: Monterrey
country: Mexico
facility: TecSalud, Escuela de Medicina y Ciencias de la Salud del ITESM
city: Managua
country: Nicaragua
facility: Hospital Carlos R Huembes/Clinica Plaza España/Clinica Centro Medico Juigalpa
city: Ciudad de Panamá
country: Panama
facility: Hospital Santo Tomás
city: Itauguá
country: Paraguay
facility: Hospital Nacional de Itaugua
state: Central
city: Asunción
country: Paraguay
facility: Hospital Central - Instituto de Previsión Social
city: Asunción
country: Paraguay
facility: Instituto Nacional de Cardiología "Prof. Dr. Juan A. Catonni"
city: Asunción
country: Paraguay
facility: Instituto Cardiovascular del Sanatorio Migone
city: Asunción
country: Paraguay
facility: Sanatorio Adventista de Asunción
city: Asunción
country: Paraguay
facility: Sanatorio Italiano
city: Concepción
country: Paraguay
facility: Clinicor Estudios Cardiológicos
city: San Lorenzo
country: Paraguay
facility: Hospital de Clínicas - Facultad de ciencias médicas
city: Chiclayo
country: Peru
facility: Luis Heysen Inchaustegui - ESSALUD
city: Lima
country: Peru
facility: Hospital María Auxiliadora
city: Lima
country: Peru
facility: Hospital Nacional Arzobispo Loayza
city: Lima
country: Peru
facility: Hospital Nacional Daniel Alcides Carrión
city: Lima
country: Peru
facility: Instituto Cardiovascular Clinicor Norte
city: Chimbote
country: Peru
facility: Hospital III EsSalud Chimbote
state: Áncash
city: Paramaribo
country: Suriname
facility: Thorax Centrum Paramaribo /Academic Hospital Paramaribo
city: Montevideo
country: Uruguay
facility: Hospital de Clínicas Doctor Manuel Quintela
city: Montevideo
country: Uruguay
facility: Médica Uruguaya
city: Puerto Ordaz
country: Venezuela
facility: Clínica Chilemex
state: Bolívar
city: Puerto Cabello
country: Venezuela
facility: Unidad Cardiovascular Ferrer
state: Carabobo
city: Valencia
country: Venezuela
facility: Centro Policlínico Valencia
state: Carabobo
city: Barquisimeto
country: Venezuela
facility: ASCARDIO
state: Lara
city: Cumaná
country: Venezuela
facility: Centro Clinico Santa Rosa
state: Sucre
city: Anzoátegui
country: Venezuela
facility: Cardiología Tropical Azoátegui
city: Cumaná
country: Venezuela
facility: Atimed C.A
city: Mérida
country: Venezuela
facility: Instituto Autónomo Hospital Universitario de Los Andes
city: Punto Fijo
country: Venezuela
facility: IVSS Hospital Dr. Rafael Calles Sierra
city: Valencia
country: Venezuela
facility: Unicor/Funvic
Study officials:
affiliation: Fundacion Clinica Valle del Lili
name: Juan E Gomez-Mesa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínica Bíblica
name: Mario Speranza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto De Cardiología J. F. Cabral
name: Eduardo R. Perna, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional del Tórax
name: Víctor A. Rossel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital San Vicente de Paul
name: Daniel Quesada, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Southwestern Medical Center
name: Mark H. Drazner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Santo Tomas
name: Alexander Romero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional Cardiovascular INCOR
name: Walter Alarco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundación Valle del Lili - Registry Coordinator
name: Sebastian Seni-Molina, MD
role: PRINCIPAL_INVESTIGATOR
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