American Registry of Ambulatory or Acutely Decompensated Heart Failure

NCT05295641 | Completed DMC

• 1 other identifier: FVL-1310
• Study Type: observational
• Target: 6,732
• Locations: 19 countries
• Sites: 101

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

Conditions

Heart Failure; Acute Heart Failure (AHF); Chronic Heart Failure

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Characteristics of population with diagnosis of heart failure in America

  Sociodemographic characteristics of patients with heart failure

  Baseline

• Characteristics of population with diagnosis of heart failure in America

  Clinical and paraclinical characteristics of patients with heart failure

  Baseline, at Month 1, Month 6 and Month 12

Secondary Outcomes (16)

• Outpatient management of heart failure

  Baseline and at Month 12

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

  Baseline and at Month 12

• Clinical and hemodynamic presentation of acutely decompensated heart failure

  Baseline

• In-hospital management of acutely decompensated heart failure

  Baseline

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

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Heart failure patients with either ambulatory diagnosis or an acute decompensation

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Fundacion Clinica Valle del Lili: lead
• Sociedad Interamericana de Cardiología (SIAC): collaborator
• Consejo Interamericano de Falla Cardíaca e Hipertensión Pulmonar (CIFACAH): collaborator

Study Sites (119)

North Shore University Hospital, Nothwell Health

Manhasset, New York, 11030, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Sanatorio Modelo Quilmes

Quilmes, Buenos Aires, 1878, Argentina

Location

Sanatorio de la Trinidad Quilmes y Centro Gallego

Quilmes, Buenos Aires, Argentina

Location

Hospital Italiano de Córdoba

Córdoba, Córdoba Province, Argentina

Location

Clinica Vrsalovic / Clinica del Angelo

Formosa, Formosa Province, 3600, Argentina

Location

Establecimiento Asistencial Gobernador Centeno

Santa Rosa, La Pampa Province, 6300, Argentina

Location

Hospital San Bernardo

Salta, Salta Province, 4400, Argentina

Location

Clínica El Castaño - CIMAC

San Juan, San Juan Province, 5400, Argentina

Location

Clínica CERHU / Hospital Central Ramón Carrillo

San Luis, San Luis Province, Argentina

Location

Instituto Cardiovascular del Rosario

Rosario, Santa Fe Province, 2000, Argentina

Location

Sanatorio Santa Clara Talar

Buenos Aires, 1617, Argentina

Location

Hospital General de Agudos Carlos G. Durand

Buenos Aires, Argentina

Location

Instituto de Cardiología Juana Francisca Cabral Bolívar

Corrientes, 3400, Argentina

Location

Hospital Privado Universitario de Córdoba

Córdoba, 5000, Argentina

Location

Instituto Modelo de Cardiología Privado SRL

Córdoba, Argentina

Location

Hospital Descentralizado Dr. Guillermo Rawson

San Juan, Argentina

Location

Hospital Público Dr. Marcial V. Quiroga

San Juan, Argentina

Location

Hospital Universitario Japonés

Santa Cruz de la Sierra, Santa Cruz Department, Bolivia

Location

Caja Petrolera de Salud

Santa Cruz de la Sierra, Bolivia

Location

Instituto Nacional del Tórax

Santiago, Chile

Location

Clinica Cardio VID

Medellín, Antioquia, 050001, Colombia

Location

Sociedad Clínica Iberoamericana

Barranquilla, Atlántico, 08000, Colombia

Location

Instituto Todo Por El Corazón

Manizales, Caldas Department, 170002, Colombia

Location

Clínica del Occidente

Bogotá, Cundinamarca, 110851, Colombia

Location

Fundación Cardioinfantil

Bogotá, Cundinamarca, 110911, Colombia

Location

Fundación Santa Fé de Bogotá

Bogotá, Cundinamarca, 110911, Colombia

Location

Hospicardio

Montería, Departamento de Córdoba, Colombia

Location

Unimedic Ips

Pasto, Departamento de Nariño, Colombia

Location

Clínica Medilaser Florencia

Florencia, Departamento del Caquetá, 180001-180009, Colombia

Location

Instituto Grupsalud

Santa Marta, Magdalena Department, 470001, Colombia

Location

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

Pereira, Risaralda Department, 660003, Colombia

Location

Fundación Cardiovascular de Colombia

Floridablanca, Santander Department, Colombia

Location

Clinica Avidanti S.A.S

Ibagué, Tolima Department, 730001, Colombia

Location

Fundación Valle del Lili

Cali, Valle del Cauca Department, 760032, Colombia

Location

Clínica General del Norte

Barranquilla, Colombia

Location

Hospital Santa Clara

Bogotá, Colombia

Location

Sociedad Cardiológica Colombiana S.A.S.

Villavicencio, Colombia

Location

Hospital San Vicente de Paúl

Heredia, 40103, Costa Rica

Location

Hospital Clínica Bíblica

San José, 10102, Costa Rica

Location

Hospital México, CCSS

San José, 10102, Costa Rica

Location

Hospital Clinico Quirurgico Docente Ivan Portuondo

San Antonio de los Baños, Artemisa, 32700, Cuba

Location

Instituto de Cardiología y Cirugía Cardiovascular

La Habana, Departamento Occidental, 10000-19999, Cuba

Location

Hospital Provincial Clinico Quirurgico Docente Leon Cuervo Rubio

Pinar del Río, Provincia de Pinar del Río, 20100, Cuba

Location

Hospital Provincial Clínico Quirúrgico Docente Carlos Manuel De Céspedes

Bayamo, Cuba

Location

Hospital Provincial Clínico Quirúrgico Docente Manuel Ascunce Domenech

Camagüey, Cuba

Location

Hospital Provincial Dr. Antonio Luaces Iraola

Ciego de Ávila, Cuba

Location

Hospital General Orlando Pantoja Tamayo

Contramaestre, Cuba

Location

Hospital Clínico Quirúrgico Docente Calixto García Íñiguez

La Habana, Cuba

Location

Hospital Clínico Quirúrgico Docente Dr. Enrique Cabrera

La Habana, Cuba

Location

Hospital Provincial Camilo Cienfuegos

La Habana, Cuba

Location

Hospital General Docente Dr. Ernesto Guevara De La Serna

Las Tunas, Cuba

Location

Hospital Provincial Clínico Quirúrgico Docente Cmte. Faustino Pérez

Matanzas, Cuba

Location

Hospital Clínico Quirúrgico Docente Héroes Del Baire

Nueva Gerona, Cuba

Location

Hospital Provincial Docente Marting Chang Puga

Nuevitas, Cuba

Location

Hospital Provincial Clínico Quirúrgico Docente Abel Santamaría

Pinar del Río, Cuba

Location

Cardiocentro Santiago de Cuba

Santiago de Cuba, Cuba

Location

Hospital Provincial Saturnino Lora

Santiago de Cuba, Cuba

Location

Clínica Universitaria Unión Médica del Norte

Santiago de los Caballeros, Santiago Province, 51000, Dominican Republic

Location

Hospital Regional Presidente Estrella Ureña

Santiago de los Caballeros, Santiago Province, 51000, Dominican Republic

Location

Centro Médico Siglo 21

San Francisco de Macorís, Dominican Republic

Location

Hospital Metropolitano de Santiago Homs

Santiago de los Caballeros, Dominican Republic

Location

Hospital Luis Vernaza

Guayaquil, Guayas, 090101 - 090158, Ecuador

Location

Hospital Clínica Kennedy

Guayaquil, Guayas, 090512, Ecuador

Location

Centro Médico de Especialidades Ameds

Manta, Manabí, EC130850, Ecuador

Location

HOSPICOR

Manta, Manabí, EC130850, Ecuador

Location

Centro Cardiológico A.C.I

Portoviejo, Manabí, EC130150, Ecuador

Location

Hospital Metropolitano

Quito, Pichincha, 170521, Ecuador

Location

Hospital José Carrasco Arteaga / Instituto ecuatoriano de seguridad social

Cuenca, Ecuador

Location

Clinica Jesús De Nazareth / Hospital San Marcos

Machala, Ecuador

Location

Hospital General EISS Portoviejo

Portoviejo, Ecuador

Location

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

Samborondón, Ecuador

Location

Clínica de Cardiología y Ortopedia CCO

San Salvador, San Salvador Department, El Salvador

Location

Instituto Salvadoreño del Seguro Social

San Salvador, San Salvador Department, El Salvador

Location

Clínica del Corazón Sinusal

San Salvador, El Salvador

Location

Hospital General San Juan de Dios

Guatemala City, Departamento de Guatemala, 1001 - 1073, Guatemala

Location

Hospital Roosevelt

Guatemala City, Departamento de Guatemala, 1001 - 1073, Guatemala

Location

Clínicas HART y Hospital Regional de Occidente

Quetzaltenango, Departamento de Quetzaltenango, 09001, Guatemala

Location

Cardiocentro Chimaltenango

Chimaltenango, 04001, Guatemala

Location

Hospital Regional de Zacapa

Zacapa, 19001, Guatemala

Location

Cardio Medical Center

Tegucigalpa, Francisco Morazán Department, 11101, Honduras

Location

Instituto Nacional Cardiopulmonar

Tegucigalpa, Francisco Morazán Department, 11101, Honduras

Location

Heart institute of the caribbean

Kingston, Jamaica

Location

Centenario Hospital Miguel Hidalgo

Aguascalientes, Aguascalientes, 20000 - 20999, Mexico

Location

Christus Muguerza Hospital Alta Especialidad

Monterrey, Nuevo León, 64000, Mexico

Location

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

Mexico City, 01000-16999, Mexico

Location

Instituto Nacional de Cardiología Ignacio Chávez

Mexico City, 14080, Mexico

Location

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran

Mexico City, 14080, Mexico

Location

Servicios Profesionales Del Sagrado Corazón De Jesús S.C.

Mexico City, Mexico

Location

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

Monterrey, Mexico

Location

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

Managua, Nicaragua

Location

Hospital Santo Tomás

Panama City, Panama

Location

Hospital Nacional de Itaugua

Itauguá, Central Department, 2740, Paraguay

Location

Hospital Central - Instituto de Previsión Social

Asunción, 1001-1925, Paraguay

Location

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

Asunción, 1001-1925, Paraguay

Location

Instituto Cardiovascular del Sanatorio Migone

Asunción, Paraguay

Location

Sanatorio Adventista de Asunción

Asunción, Paraguay

Location

Sanatorio Italiano

Asunción, Paraguay

Location

Clinicor Estudios Cardiológicos

Concepción, Paraguay

Location

Hospital de Clínicas - Facultad de ciencias médicas

San Lorenzo, Paraguay

Location

Hospital III EsSalud Chimbote

Chimbote, Ancash, Peru

Location

Luis Heysen Inchaustegui - ESSALUD

Chiclayo, Peru

Location

Hospital María Auxiliadora

Lima, 15056, Peru

Location

Hospital Nacional Arzobispo Loayza

Lima, Peru

Location

Hospital Nacional Daniel Alcides Carrión

Lima, Peru

Location

Instituto Cardiovascular Clinicor Norte

Lima, Peru

Location

Thorax Centrum Paramaribo /Academic Hospital Paramaribo

Paramaribo, Suriname

Location

Hospital de Clínicas Doctor Manuel Quintela

Montevideo, 11000, Uruguay

Location

Médica Uruguaya

Montevideo, Uruguay

Location

Clínica Chilemex

Puerto Ordaz and San Felix, Bolívar, 8050, Venezuela

Location

Unidad Cardiovascular Ferrer

Puerto Cabello, Carabobo, Venezuela

Location

Centro Policlínico Valencia

Valencia, Carabobo, 2001, Venezuela

Location

ASCARDIO

Barquisimeto, Lara, 3001, Venezuela

Location

Instituto Autónomo Hospital Universitario de Los Andes

Mérida, Mérida, 5101, Venezuela

Location

Centro Clinico Santa Rosa

Cumaná, Sucre, 6101, Venezuela

Location

Cardiología Tropical Azoátegui

Anzoátegui, Venezuela

Location

Atimed C.A

Cumaná, Venezuela

Location

IVSS Hospital Dr. Rafael Calles Sierra

Punto Fijo, Venezuela

Location

Unicor/Funvic

Valencia, Venezuela

Location

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MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Cardiology Department

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 25, 2022
• Study Start: April 1, 2022
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (8); DO (4); JA (1); ME (7); PE (6); SU (1); EC (10); CO (3); EL (3); GU (5); UR (2); CL (1); NI (1); AR (16); VE (10); BO (2); US (2); CU (17); HO (2)