American Registry of Ambulatory or Acutely Decompensated Heart Failure

NCT ID: NCT05295641

Last Updated: 2025-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6732 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2025-01-31

Brief Summary

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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

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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

Conditions

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Heart Failure Acute Heart Failure (AHF) Chronic Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sociedad Interamericana de Cardiología (SIAC)

UNKNOWN

Sponsor Role collaborator

Consejo Interamericano de Falla Cardíaca e Hipertensión Pulmonar (CIFACAH)

UNKNOWN

Sponsor Role collaborator

Fundacion Clinica Valle del Lili

OTHER

Sponsor Role lead

Responsible Party

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Juan Esteban Gomez

Chief of the Cardiology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juan E Gomez-Mesa, MD

Role: PRINCIPAL_INVESTIGATOR

Fundacion Clinica Valle del Lili

Mario Speranza, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínica Bíblica

Eduardo R. Perna, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto De Cardiología J. F. Cabral

Víctor A. Rossel, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional del Tórax

Daniel Quesada, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital San Vicente de Paul

Mark H. Drazner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Alexander Romero, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Santo Tomas

Walter Alarco, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional Cardiovascular INCOR

Sebastian Seni-Molina, MD

Role: PRINCIPAL_INVESTIGATOR

Fundación Valle del Lili - Registry Coordinator

Locations

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North Shore University Hospital, Nothwell Health

Manhasset, New York, United States

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Sanatorio Modelo Quilmes

Quilmes, Buenos Aires, Argentina

Site Status

Sanatorio de la Trinidad Quilmes y Centro Gallego

Quilmes, Buenos Aires, Argentina

Site Status

Hospital Italiano de Córdoba

Córdoba, Córdoba Province, Argentina

Site Status

Clinica Vrsalovic / Clinica del Angelo

Formosa, Formosa Province, Argentina

Site Status

Establecimiento Asistencial Gobernador Centeno

Santa Rosa, La Pampa Province, Argentina

Site Status

Hospital San Bernardo

Salta, Salta Province, Argentina

Site Status

Clínica El Castaño - CIMAC

San Juan, San Juan Province, Argentina

Site Status

Clínica CERHU / Hospital Central Ramón Carrillo

San Luis, San Luis Province, Argentina

Site Status

Instituto Cardiovascular del Rosario

Rosario, Santa Fe Province, Argentina

Site Status

Sanatorio Santa Clara Talar

Buenos Aires, , Argentina

Site Status

Hospital General de Agudos Carlos G. Durand

Buenos Aires, , Argentina

Site Status

Instituto de Cardiología Juana Francisca Cabral Bolívar

Corrientes, , Argentina

Site Status

Hospital Privado Universitario de Córdoba

Córdoba, , Argentina

Site Status

Instituto Modelo de Cardiología Privado SRL

Córdoba, , Argentina

Site Status

Hospital Descentralizado Dr. Guillermo Rawson

San Juan, , Argentina

Site Status

Hospital Público Dr. Marcial V. Quiroga

San Juan, , Argentina

Site Status

Hospital Universitario Japonés

Santa Cruz de la Sierra, Santa Cruz Department, Bolivia

Site Status

Caja Petrolera de Salud

Santa Cruz de la Sierra, , Bolivia

Site Status

Instituto Nacional del Tórax

Santiago, , Chile

Site Status

Clinica Cardio VID

Medellín, Antioquia, Colombia

Site Status

Sociedad Clínica Iberoamericana

Barranquilla, Atlántico, Colombia

Site Status

Instituto Todo Por El Corazón

Manizales, Caldas Department, Colombia

Site Status

Clínica del Occidente

Bogotá, Cundinamarca, Colombia

Site Status

Fundación Cardioinfantil

Bogotá, Cundinamarca, Colombia

Site Status

Fundación Santa Fé de Bogotá

Bogotá, Cundinamarca, Colombia

Site Status

Hospicardio

Montería, Departamento de Córdoba, Colombia

Site Status

Unimedic Ips

Pasto, Departamento de Nariño, Colombia

Site Status

Clínica Medilaser Florencia

Florencia, Departamento del Caquetá, Colombia

Site Status

Instituto Grupsalud

Santa Marta, Magdalena Department, Colombia

Site Status

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

Pereira, Risaralda Department, Colombia

Site Status

Fundación Cardiovascular de Colombia

Floridablanca, Santander Department, Colombia

Site Status

Clinica Avidanti S.A.S

Ibagué, Tolima Department, Colombia

Site Status

Fundación Valle del Lili

Cali, Valle del Cauca Department, Colombia

Site Status

Clínica General del Norte

Barranquilla, , Colombia

Site Status

Hospital Santa Clara

Bogotá, , Colombia

Site Status

Sociedad Cardiológica Colombiana S.A.S.

Villavicencio, , Colombia

Site Status

Hospital San Vicente de Paúl

Heredia, , Costa Rica

Site Status

Hospital Clínica Bíblica

San José, , Costa Rica

Site Status

Hospital México, CCSS

San José, , Costa Rica

Site Status

Hospital Clinico Quirurgico Docente Ivan Portuondo

San Antonio de los Baños, Artemisa, Cuba

Site Status

Instituto de Cardiología y Cirugía Cardiovascular

La Habana, Departamento Occidental, Cuba

Site Status

Hospital Provincial Clinico Quirurgico Docente Leon Cuervo Rubio

Pinar del Río, Provincia de Pinar del Río, Cuba

Site Status

Hospital Provincial Clínico Quirúrgico Docente Carlos Manuel De Céspedes

Bayamo, , Cuba

Site Status

Hospital Provincial Clínico Quirúrgico Docente Manuel Ascunce Domenech

Camagüey, , Cuba

Site Status

Hospital Provincial Dr. Antonio Luaces Iraola

Ciego de Ávila, , Cuba

Site Status

Hospital General Orlando Pantoja Tamayo

Contramaestre, , Cuba

Site Status

Hospital Clínico Quirúrgico Docente Calixto García Íñiguez

La Habana, , Cuba

Site Status

Hospital Clínico Quirúrgico Docente Dr. Enrique Cabrera

La Habana, , Cuba

Site Status

Hospital Provincial Camilo Cienfuegos

La Habana, , Cuba

Site Status

Hospital General Docente Dr. Ernesto Guevara De La Serna

Las Tunas, , Cuba

Site Status

Hospital Provincial Clínico Quirúrgico Docente Cmte. Faustino Pérez

Matanzas, , Cuba

Site Status

Hospital Clínico Quirúrgico Docente Héroes Del Baire

Nueva Gerona, , Cuba

Site Status

Hospital Provincial Docente Marting Chang Puga

Nuevitas, , Cuba

Site Status

Hospital Provincial Clínico Quirúrgico Docente Abel Santamaría

Pinar del Río, , Cuba

Site Status

Cardiocentro Santiago de Cuba

Santiago de Cuba, , Cuba

Site Status

Hospital Provincial Saturnino Lora

Santiago de Cuba, , Cuba

Site Status

Clínica Universitaria Unión Médica del Norte

Santiago de los Caballeros, Santiago Province, Dominican Republic

Site Status

Hospital Regional Presidente Estrella Ureña

Santiago de los Caballeros, Santiago Province, Dominican Republic

Site Status

Centro Médico Siglo 21

San Francisco de Macorís, , Dominican Republic

Site Status

Hospital Metropolitano de Santiago Homs

Santiago de los Caballeros, , Dominican Republic

Site Status

Hospital Luis Vernaza

Guayaquil, Guayas, Ecuador

Site Status

Hospital Clínica Kennedy

Guayaquil, Guayas, Ecuador

Site Status

Centro Médico de Especialidades Ameds

Manta, Manabí, Ecuador

Site Status

HOSPICOR

Manta, Manabí, Ecuador

Site Status

Centro Cardiológico A.C.I

Portoviejo, Manabí, Ecuador

Site Status

Hospital Metropolitano

Quito, Pichincha, Ecuador

Site Status

Hospital José Carrasco Arteaga / Instituto ecuatoriano de seguridad social

Cuenca, , Ecuador

Site Status

Clinica Jesús De Nazareth / Hospital San Marcos

Machala, , Ecuador

Site Status

Hospital General EISS Portoviejo

Portoviejo, , Ecuador

Site Status

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

Samborondón, , Ecuador

Site Status

Clínica de Cardiología y Ortopedia CCO

San Salvador, San Salvador Department, El Salvador

Site Status

Instituto Salvadoreño del Seguro Social

San Salvador, San Salvador Department, El Salvador

Site Status

Clínica del Corazón Sinusal

San Salvador, , El Salvador

Site Status

Hospital General San Juan de Dios

Guatemala City, Departamento de Guatemala, Guatemala

Site Status

Hospital Roosevelt

Guatemala City, Departamento de Guatemala, Guatemala

Site Status

Clínicas HART y Hospital Regional de Occidente

Quetzaltenango, Departamento de Quetzaltenango, Guatemala

Site Status

Cardiocentro Chimaltenango

Chimaltenango, , Guatemala

Site Status

Hospital Regional de Zacapa

Zacapa, , Guatemala

Site Status

Cardio Medical Center

Tegucigalpa, Francisco Morazán Department, Honduras

Site Status

Instituto Nacional Cardiopulmonar

Tegucigalpa, Francisco Morazán Department, Honduras

Site Status

Heart institute of the caribbean

Kingston, , Jamaica

Site Status

Centenario Hospital Miguel Hidalgo

Aguascalientes, Aguascalientes, Mexico

Site Status

Christus Muguerza Hospital Alta Especialidad

Monterrey, Nuevo León, Mexico

Site Status

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

Mexico City, , Mexico

Site Status

Instituto Nacional de Cardiología Ignacio Chávez

Mexico City, , Mexico

Site Status

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran

Mexico City, , Mexico

Site Status

Servicios Profesionales Del Sagrado Corazón De Jesús S.C.

Mexico City, , Mexico

Site Status

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

Monterrey, , Mexico

Site Status

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

Managua, , Nicaragua

Site Status

Hospital Santo Tomás

Panama City, , Panama

Site Status

Hospital Nacional de Itaugua

Itauguá, Central Department, Paraguay

Site Status

Hospital Central - Instituto de Previsión Social

Asunción, , Paraguay

Site Status

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

Asunción, , Paraguay

Site Status

Instituto Cardiovascular del Sanatorio Migone

Asunción, , Paraguay

Site Status

Sanatorio Adventista de Asunción

Asunción, , Paraguay

Site Status

Sanatorio Italiano

Asunción, , Paraguay

Site Status

Clinicor Estudios Cardiológicos

Concepción, , Paraguay

Site Status

Hospital de Clínicas - Facultad de ciencias médicas

San Lorenzo, , Paraguay

Site Status

Hospital III EsSalud Chimbote

Chimbote, Ancash, Peru

Site Status

Luis Heysen Inchaustegui - ESSALUD

Chiclayo, , Peru

Site Status

Hospital María Auxiliadora

Lima, , Peru

Site Status

Hospital Nacional Arzobispo Loayza

Lima, , Peru

Site Status

Hospital Nacional Daniel Alcides Carrión

Lima, , Peru

Site Status

Instituto Cardiovascular Clinicor Norte

Lima, , Peru

Site Status

Thorax Centrum Paramaribo /Academic Hospital Paramaribo

Paramaribo, , Suriname

Site Status

Hospital de Clínicas Doctor Manuel Quintela

Montevideo, , Uruguay

Site Status

Médica Uruguaya

Montevideo, , Uruguay

Site Status

Clínica Chilemex

Puerto Ordaz and San Felix, Bolívar, Venezuela

Site Status

Unidad Cardiovascular Ferrer

Puerto Cabello, Carabobo, Venezuela

Site Status

Centro Policlínico Valencia

Valencia, Carabobo, Venezuela

Site Status

ASCARDIO

Barquisimeto, Lara, Venezuela

Site Status

Instituto Autónomo Hospital Universitario de Los Andes

Mérida, Mérida, Venezuela

Site Status

Centro Clinico Santa Rosa

Cumaná, Sucre, Venezuela

Site Status

Cardiología Tropical Azoátegui

Anzoátegui, , Venezuela

Site Status

Atimed C.A

Cumaná, , Venezuela

Site Status

IVSS Hospital Dr. Rafael Calles Sierra

Punto Fijo, , Venezuela

Site Status

Unicor/Funvic

Valencia, , Venezuela

Site Status

Countries

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United States Argentina Bolivia Chile Colombia Costa Rica Cuba Dominican Republic Ecuador El Salvador Guatemala Honduras Jamaica Mexico Nicaragua Panama Paraguay Peru Suriname Uruguay Venezuela

References

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Ho KK, Pinsky JL, Kannel WB, Levy D. The epidemiology of heart failure: the Framingham Study. J Am Coll Cardiol. 1993 Oct;22(4 Suppl A):6A-13A. doi: 10.1016/0735-1097(93)90455-a.

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Metra M, Ponikowski P, Dickstein K, McMurray JJ, Gavazzi A, Bergh CH, Fraser AG, Jaarsma T, Pitsis A, Mohacsi P, Bohm M, Anker S, Dargie H, Brutsaert D, Komajda M; Heart Failure Association of the European Society of Cardiology. Advanced chronic heart failure: A position statement from the Study Group on Advanced Heart Failure of the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2007 Jun-Jul;9(6-7):684-94. doi: 10.1016/j.ejheart.2007.04.003. Epub 2007 May 3.

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Other Identifiers

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FVL-1310

Identifier Type: -

Identifier Source: org_study_id

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