MedPath

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

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
NameTimeMethod
Characteristics of population with diagnosis of heart failure in AmericaBaseline, at Month 1, Month 6 and Month 12

Clinical and paraclinical characteristics of patients with heart failure

Secondary Outcome Measures
NameTimeMethod
Outpatient management of heart failureBaseline 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 treatmentBaseline, 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 survivalBaseline, Month 1, Month 6 and Month 12

Evaluate cumulative survival and heart failure readmission-free survival

In-hospital management of acutely decompensated heart failureBaseline

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 dischargeMonth 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 characteristicsBaseline

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 failureBaseline

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

Proportion of in-hospital mortality related with acute decompensation of heart failureBaseline

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 dischargeBaseline, 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 devicesBaseline, 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 mortalityBaseline 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 dischargeMonth 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 dischargeMonth 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 dischargeMonth 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 dischargeMonth 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 characteristicsBaseline

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)

University of Texas Southwestern Medical Center

🇺🇸

Dallas, Texas, United States

Hospital Luis Vernaza

🇪🇨

Guayaquil, Guayas, Ecuador

Hospital Clínica Kennedy

🇪🇨

Guayaquil, Guayas, Ecuador

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

Clinica Avidanti S.A.S

🇨🇴

Ibagué, Tolima, Colombia

Hospital Provincial Clínico Quirúrgico Docente Manuel Ascunce Domenech

🇨🇺

Camagüey, Cuba

Sociedad Cardiológica Colombiana S.A.S.

🇨🇴

Villavicencio, Colombia

Hospital San Vicente de Paúl

🇨🇷

Heredia, Costa Rica

Instituto de Cardiología y Cirugía Cardiovascular

🇨🇺

La Habana, Departamento Occidental, Cuba

Hospital Provincial Saturnino Lora

🇨🇺

Santiago de Cuba, Cuba

Clínica Universitaria Unión Médica del Norte

🇩🇴

Santiago De Los Caballeros, Santiago, Dominican Republic

Hospital Roosevelt

🇬🇹

Ciudad de Guatemala, Guatemala

Christus Muguerza Hospital Alta Especialidad

🇲🇽

Monterrey, Nuevo León, Mexico

Centenario Hospital Miguel Hidalgo

🇲🇽

Aguascalientes, Mexico

Sanatorio Italiano

🇵🇾

Asunción, Paraguay

IVSS Hospital Dr. Rafael Calles Sierra

🇻🇪

Punto Fijo, Venezuela

Sanatorio Santa Clara Talar

🇦🇷

Buenos Aires, Argentina

Sociedad Clínica Iberoamericana

🇨🇴

Barranquilla, Atlantico, Colombia

Hospicardio

🇨🇴

Montería, Córdoba, Colombia

Hospital Clínica Bíblica

🇨🇷

San José, Costa Rica

Hospital General de Agudos Carlos G. Durand

🇦🇷

Buenos Aires, Argentina

Atimed C.A

🇻🇪

Cumaná, Venezuela

Instituto Autónomo Hospital Universitario de Los Andes

🇻🇪

Mérida, Venezuela

Unimedic Ips

🇨🇴

Pasto, Nariño, Colombia

Hospital Carlos R Huembes/Clinica Plaza España/Clinica Centro Medico Juigalpa

🇳🇮

Managua, Nicaragua

Cardiocentro Santiago de Cuba

🇨🇺

Santiago de Cuba, Cuba

North Shore University Hospital, Nothwell Health

🇺🇸

Manhasset, New York, United States

Instituto Cardiovascular del Rosario

🇦🇷

Rosario, Santa Fé, Argentina

Instituto de Cardiología Juana Francisca Cabral Bolívar

🇦🇷

Corrientes, Argentina

Hospital Privado Universitario de Córdoba

🇦🇷

Córdoba, Argentina

Instituto Modelo de Cardiología Privado SRL

🇦🇷

Córdoba, Argentina

Hospital San Bernardo

🇦🇷

Salta, Argentina

Hospital Italiano de Córdoba

🇦🇷

Córdoba, Argentina

Clinica Vrsalovic / Clinica del Angelo

🇦🇷

Formosa, Argentina

Clínica El Castaño - CIMAC

🇦🇷

San Juan, Argentina

Caja Petrolera de Salud

🇧🇴

Santa Cruz de la Sierra, Bolivia

Hospital Descentralizado Dr. Guillermo Rawson

🇦🇷

San Juan, Argentina

Hospital Público Dr. Marcial V. Quiroga

🇦🇷

San Juan, Argentina

Hospital Universitario Japonés

🇧🇴

Santa Cruz de la Sierra, Santa Cruz, Bolivia

Clínica CERHU / Hospital Central Ramón Carrillo

🇦🇷

San Luis, Argentina

Instituto Nacional del Tórax

🇨🇱

Santiago, Chile

Clinica Cardio VID

🇨🇴

Medellín, Antioquia, Colombia

Clínica del Occidente

🇨🇴

Bogotá, Cundinamarca, Colombia

Instituto Todo Por El Corazón

🇨🇴

Manizales, Caldas, Colombia

Fundación Cardioinfantil

🇨🇴

Bogotá, Cundinamarca, Colombia

Clínica Medilaser Florencia

🇨🇴

Florencia, Caquetá, Colombia

Fundación Santa Fé de Bogotá

🇨🇴

Bogotá, Cundinamarca, Colombia

Clínica los Rosales S.A. - Centro Médico para el Corazón

🇨🇴

Pereira, Risaralda, Colombia

Instituto Grupsalud

🇨🇴

Santa Marta, Magdalena, Colombia

Fundación Valle del Lili

🇨🇴

Santiago de Cali, Valle, Colombia

Clínica General del Norte

🇨🇴

Barranquilla, Colombia

Fundación Cardiovascular de Colombia

🇨🇴

Floridablanca, Santander, Colombia

Hospital Santa Clara

🇨🇴

Bogotá, Colombia

Hospital Clinico Quirurgico Docente Ivan Portuondo

🇨🇺

San Antonio de los Baños, Artemisa, Cuba

Hospital México, CCSS

🇨🇷

San José, Costa Rica

Hospital Provincial Clínico Quirúrgico Docente Carlos Manuel De Céspedes

🇨🇺

Bayamo, Cuba

Hospital General Orlando Pantoja Tamayo

🇨🇺

Contramaestre, Cuba

Hospital Provincial Dr. Antonio Luaces Iraola

🇨🇺

Ciego De Ávila, Cuba

Hospital Clínico Quirúrgico Docente Dr. Enrique Cabrera

🇨🇺

La Habana, Cuba

Hospital Clínico Quirúrgico Docente Calixto García Íñiguez

🇨🇺

La Habana, Cuba

Hospital Provincial Camilo Cienfuegos

🇨🇺

La Habana, Cuba

Hospital Clínico Quirúrgico Docente Héroes Del Baire

🇨🇺

Nueva Gerona, Cuba

Hospital General Docente Dr. Ernesto Guevara De La Serna

🇨🇺

Las Tunas, Cuba

Hospital Provincial Docente Marting Chang Puga

🇨🇺

Nuevitas, Cuba

Hospital Provincial Clínico Quirúrgico Docente Cmte. Faustino Pérez

🇨🇺

Matanzas, Cuba

Hospital Provincial Clínico Quirúrgico Docente Abel Santamaría

🇨🇺

Pinar Del Río, Cuba

Hospital Provincial Clinico Quirurgico Docente Leon Cuervo Rubio

🇨🇺

Pinar del Rio, Cuba

Centro Médico Siglo 21

🇩🇴

San Francisco de Macoris, Dominican Republic

Hospital Metropolitano de Santiago Homs

🇩🇴

Santiago De Los Caballeros, Dominican Republic

Hospital Regional Presidente Estrella Ureña

🇩🇴

Santiago De Los Caballeros, Santiago, Dominican Republic

Centro Médico de Especialidades Ameds

🇪🇨

Manta, Manabí, Ecuador

HOSPICOR

🇪🇨

Manta, Manabí, Ecuador

Hospital Metropolitano

🇪🇨

Quito, Pichincha, Ecuador

Centro Cardiológico A.C.I

🇪🇨

Portoviejo, Manabí, Ecuador

Clinica Jesús De Nazareth / Hospital San Marcos

🇪🇨

Machala, Ecuador

Hospital José Carrasco Arteaga / Instituto ecuatoriano de seguridad social

🇪🇨

Cuenca, Ecuador

Clínica de Cardiología y Ortopedia CCO

🇸🇻

San Salvador, El Salvador

Hospital General EISS Portoviejo

🇪🇨

Portoviejo, Ecuador

Centro De Diagnóstico Y Tratamiento De Enfermedades (Cdt) Cardiovasculares Cardioheredia

🇪🇨

Samborondón, Ecuador

Clínica del Corazón Sinusal

🇸🇻

San Salvador, El Salvador

Instituto Salvadoreño del Seguro Social

🇸🇻

San Salvador, El Salvador

Cardiocentro Chimaltenango

🇬🇹

Chimaltenango, Guatemala

Hospital Regional de Zacapa

🇬🇹

Zacapa, Guatemala

Hospital General San Juan de Dios

🇬🇹

Ciudad de Guatemala, Guatemala

Clínicas HART y Hospital Regional de Occidente

🇬🇹

Quetzaltenango, Guatemala

Cardio Medical Center

🇭🇳

Tegucigalpa, Francisco Morazán, Honduras

Instituto Nacional Cardiopulmonar

🇭🇳

Tegucigalpa, Francisco Morazán, Honduras

Hospital Español. Sociedad de Beneficencia Española I.A.P

🇲🇽

Ciudad de México, Mexico

Heart institute of the caribbean

🇯🇲

Kingston, Jamaica

Instituto Nacional de Cardiología Ignacio Chávez

🇲🇽

Ciudad de México, Mexico

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran

🇲🇽

Ciudad de México, Mexico

TecSalud, Escuela de Medicina y Ciencias de la Salud del ITESM

🇲🇽

Monterrey, Mexico

Servicios Profesionales Del Sagrado Corazón De Jesús S.C.

🇲🇽

Ciudad de México, Mexico

Hospital Santo Tomás

🇵🇦

Ciudad de Panamá, Panama

Hospital Nacional de Itaugua

🇵🇾

Itauguá, Central, Paraguay

Hospital Central - Instituto de Previsión Social

🇵🇾

Asunción, Paraguay

Instituto Nacional de Cardiología "Prof. Dr. Juan A. Catonni"

🇵🇾

Asunción, Paraguay

Instituto Cardiovascular del Sanatorio Migone

🇵🇾

Asunción, Paraguay

Sanatorio Adventista de Asunción

🇵🇾

Asunción, Paraguay

Clinicor Estudios Cardiológicos

🇵🇾

Concepción, Paraguay

Hospital de Clínicas - Facultad de ciencias médicas

🇵🇾

San Lorenzo, Paraguay

Hospital María Auxiliadora

🇵🇪

Lima, Peru

Luis Heysen Inchaustegui - ESSALUD

🇵🇪

Chiclayo, Peru

Hospital Nacional Daniel Alcides Carrión

🇵🇪

Lima, Peru

Instituto Cardiovascular Clinicor Norte

🇵🇪

Lima, Peru

Hospital Nacional Arzobispo Loayza

🇵🇪

Lima, Peru

Unidad Cardiovascular Ferrer

🇻🇪

Puerto Cabello, Carabobo, Venezuela

Thorax Centrum Paramaribo /Academic Hospital Paramaribo

🇸🇷

Paramaribo, Suriname

Hospital de Clínicas Doctor Manuel Quintela

🇺🇾

Montevideo, Uruguay

Médica Uruguaya

🇺🇾

Montevideo, Uruguay

Hospital III EsSalud Chimbote

🇵🇪

Chimbote, Áncash, Peru

Clínica Chilemex

🇻🇪

Puerto Ordaz, Bolívar, Venezuela

ASCARDIO

🇻🇪

Barquisimeto, Lara, Venezuela

Centro Policlínico Valencia

🇻🇪

Valencia, Carabobo, Venezuela

Centro Clinico Santa Rosa

🇻🇪

Cumaná, Sucre, Venezuela

Cardiología Tropical Azoátegui

🇻🇪

Anzoátegui, Venezuela

Unicor/Funvic

🇻🇪

Valencia, Venezuela

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