Heart FailureAMERICCAASSNCT05295641
American Registry of Ambulatory or Acutely Decompensated Heart Failure
An observational study of Heart Failure and Acute Heart Failure (AHF), run by Fundacion Clinica Valle del Lili at 119 sites in 21 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Acute Heart Failure (AHF), Chronic Heart Failure
- How many people
- 6,732 participants
- Where
- 119 sitesin 21 countries
- Study dates
- 1 Apr 2022to 31 Jan 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart failure patients with either ambulatory diagnosis or an acute decompensation
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
119 sites in 21 countries.
119 sites in 21 countries
Colombia17 sites
Sociedad Clínica Iberoamericana
Barranquilla, Atlántico, 08000
Clínica General del Norte
Barranquilla
Clínica del Occidente
Bogotá, Cundinamarca, 110851
Fundación Cardioinfantil
Bogotá, Cundinamarca, 110911
Fundación Santa Fé de Bogotá
Bogotá, Cundinamarca, 110911
Hospital Santa Clara
Bogotá
Fundación Valle del Lili
Cali, Valle del Cauca Department, 760032
Clínica Medilaser Florencia
Florencia, Departamento del Caquetá, 180001-180009
Fundación Cardiovascular de Colombia
Floridablanca, Santander Department
Clinica Avidanti S.A.S
Ibague, Tolima Department, 730001
Instituto Todo Por El Corazón
Manizales, Caldas Department, 170002
Clinica Cardio VID
Medellín, Antioquia, 050001
Hospicardio
Montería, Departamento de Córdoba
Unimedic Ips
Pasto, Departamento de Nariño
Clínica los Rosales S.A. - Centro Médico para el Corazón
Pereira, Risaralda Department, 660003
Instituto Grupsalud
Santa Marta, Magdalena Department, 470001
Sociedad Cardiológica Colombiana S.A.S.
Villavicencio
Cuba17 sites
Hospital Provincial Clínico Quirúrgico Docente Carlos Manuel De Céspedes
Bayamo
Hospital Provincial Clínico Quirúrgico Docente Manuel Ascunce Domenech
Camagüey
Hospital Provincial Dr. Antonio Luaces Iraola
Ciego de Ávila
Hospital General Orlando Pantoja Tamayo
Contramaestre
Instituto de Cardiología y Cirugía Cardiovascular
La Habana, Departamento Occidental, 10000-19999
Hospital Clínico Quirúrgico Docente Calixto García Íñiguez
La Habana
Hospital Clínico Quirúrgico Docente Dr. Enrique Cabrera
La Habana
Hospital Provincial Camilo Cienfuegos
La Habana
Hospital General Docente Dr. Ernesto Guevara De La Serna
Las Tunas
Hospital Provincial Clínico Quirúrgico Docente Cmte. Faustino Pérez
Matanzas
Hospital Clínico Quirúrgico Docente Héroes Del Baire
Nueva Gerona
Hospital Provincial Docente Marting Chang Puga
Nuevitas
Hospital Provincial Clinico Quirurgico Docente Leon Cuervo Rubio
Pinar del Río, Provincia de Pinar del Río, 20100
Hospital Provincial Clínico Quirúrgico Docente Abel Santamaría
Pinar del Río
Hospital Clinico Quirurgico Docente Ivan Portuondo
San Antonio de los Baños, Artemisa, 32700
Cardiocentro Santiago de Cuba
Santiago de Cuba
Hospital Provincial Saturnino Lora
Santiago de Cuba
Argentina16 sites
Sanatorio Santa Clara Talar
Buenos Aires, 1617
Hospital General de Agudos Carlos G. Durand
Buenos Aires
Hospital Italiano de Córdoba
Córdoba, Córdoba Province
Hospital Privado Universitario de Córdoba
Córdoba, 5000
Instituto Modelo de Cardiología Privado SRL
Córdoba
Instituto de Cardiología Juana Francisca Cabral Bolívar
Corrientes, 3400
Clinica Vrsalovic / Clinica del Angelo
Formosa, Formosa Province, 3600
Sanatorio Modelo Quilmes
Quilmes, Buenos Aires, 1878
Sanatorio de la Trinidad Quilmes y Centro Gallego
Quilmes, Buenos Aires
Instituto Cardiovascular del Rosario
Rosario, Santa Fe Province, 2000
Hospital San Bernardo
Salta, Salta Province, 4400
Clínica El Castaño - CIMAC
San Juan, San Juan Province, 5400
Hospital Descentralizado Dr. Guillermo Rawson
San Juan
Hospital Público Dr. Marcial V. Quiroga
San Juan
Clínica CERHU / Hospital Central Ramón Carrillo
San Luis, San Luis Province
Establecimiento Asistencial Gobernador Centeno
Santa Rosa, La Pampa Province, 6300
Ecuador10 sites
Hospital José Carrasco Arteaga / Instituto ecuatoriano de seguridad social
Cuenca
Hospital Luis Vernaza
Guayaquil, Guayas, 090101 - 090158
Hospital Clínica Kennedy
Guayaquil, Guayas, 090512
Clinica Jesús De Nazareth / Hospital San Marcos
Machala
Centro Médico de Especialidades Ameds
Manta, Manabí, EC130850
HOSPICOR
Manta, Manabí, EC130850
Centro Cardiológico A.C.I
Portoviejo, Manabí, EC130150
Hospital General EISS Portoviejo
Portoviejo
Hospital Metropolitano
Quito, Pichincha, 170521
Centro De Diagnóstico Y Tratamiento De Enfermedades (Cdt) Cardiovasculares Cardioheredia
Samborondón
Venezuela10 sites
Cardiología Tropical Azoátegui
Anzoátegui
ASCARDIO
Barquisimeto, Lara, 3001
Centro Clinico Santa Rosa
Cumaná, Sucre, 6101
Atimed C.A
Cumaná
Instituto Autónomo Hospital Universitario de Los Andes
Mérida, Mérida, 5101
Unidad Cardiovascular Ferrer
Puerto Cabello, Carabobo
Clínica Chilemex
Puerto Ordaz and San Felix, Bolívar, 8050
IVSS Hospital Dr. Rafael Calles Sierra
Punto Fijo
Centro Policlínico Valencia
Valencia, Carabobo, 2001
Unicor/Funvic
Valencia
Paraguay8 sites
Hospital Central - Instituto de Previsión Social
Asunción, 1001-1925
Instituto Nacional de Cardiología "Prof. Dr. Juan A. Catonni"
Asunción, 1001-1925
Instituto Cardiovascular del Sanatorio Migone
Asunción
Sanatorio Adventista de Asunción
Asunción
Sanatorio Italiano
Asunción
Clinicor Estudios Cardiológicos
Concepción
Hospital Nacional de Itaugua
Itauguá, Central Department, 2740
Hospital de Clínicas - Facultad de ciencias médicas
San Lorenzo
Mexico7 sites
Centenario Hospital Miguel Hidalgo
Aguascalientes, Aguascalientes, 20000 - 20999
Hospital Español. Sociedad de Beneficencia Española I.A.P
Mexico City, 01000-16999
Instituto Nacional de Cardiología Ignacio Chávez
Mexico City, 14080
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran
Mexico City, 14080
Servicios Profesionales Del Sagrado Corazón De Jesús S.C.
Mexico City
Christus Muguerza Hospital Alta Especialidad
Monterrey, Nuevo León, 64000
TecSalud, Escuela de Medicina y Ciencias de la Salud del ITESM
Monterrey
Peru6 sites
Luis Heysen Inchaustegui - ESSALUD
Chiclayo
Hospital III EsSalud Chimbote
Chimbote, Ancash
Hospital María Auxiliadora
Lima, 15056
Hospital Nacional Arzobispo Loayza
Lima
Hospital Nacional Daniel Alcides Carrión
Lima
Instituto Cardiovascular Clinicor Norte
Lima
Guatemala5 sites
Cardiocentro Chimaltenango
Chimaltenango, 04001
Hospital General San Juan de Dios
Guatemala City, Departamento de Guatemala, 1001 - 1073
Hospital Roosevelt
Guatemala City, Departamento de Guatemala, 1001 - 1073
Clínicas HART y Hospital Regional de Occidente
Quetzaltenango, Departamento de Quetzaltenango, 09001
Hospital Regional de Zacapa
Zacapa, 19001
Dominican Republic4 sites
Centro Médico Siglo 21
San Francisco de Macorís
Clínica Universitaria Unión Médica del Norte
Santiago de los Caballeros, Santiago Province, 51000
Hospital Regional Presidente Estrella Ureña
Santiago de los Caballeros, Santiago Province, 51000
Hospital Metropolitano de Santiago Homs
Santiago de los Caballeros
Costa Rica3 sites
Hospital San Vicente de Paúl
Heredia, 40103
Hospital Clínica Bíblica
San José, 10102
Hospital México, CCSS
San José, 10102
El Salvador3 sites
Clínica de Cardiología y Ortopedia CCO
San Salvador, San Salvador Department
Instituto Salvadoreño del Seguro Social
San Salvador, San Salvador Department
Clínica del Corazón Sinusal
San Salvador
United States2 sites
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
North Shore University Hospital, Nothwell Health
Manhasset, New York, 11030
Bolivia2 sites
Hospital Universitario Japonés
Santa Cruz de la Sierra, Santa Cruz Department
Caja Petrolera de Salud
Santa Cruz de la Sierra
Honduras2 sites
Cardio Medical Center
Tegucigalpa, Francisco Morazán Department, 11101
Instituto Nacional Cardiopulmonar
Tegucigalpa, Francisco Morazán Department, 11101
Uruguay2 sites
Hospital de Clínicas Doctor Manuel Quintela
Montevideo, 11000
Médica Uruguaya
Montevideo
Nicaragua1 site
Hospital Carlos R Huembes/Clinica Plaza España/Clinica Centro Medico Juigalpa
Managua
Suriname1 site
Thorax Centrum Paramaribo /Academic Hospital Paramaribo
Paramaribo
About this study
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
Read the 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
- Keywords
- Decompensated, Outpatient, Treatment, Hospitalization, Mortality, Heart Failure, Americas, Registry, Inpatient
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of population with diagnosis of heart failure in America
Sociodemographic characteristics of patients with heart failure
Measured: Baseline
Characteristics of population with diagnosis of heart failure in America
Clinical and paraclinical characteristics of patients with heart failure
Measured: Baseline, at Month 1, Month 6 and Month 12
Secondary outcomes (16)
Outpatient management of heart failure
Describe the ambulatory/outpatient management of patients with heart failure
Measured: Baseline and at Month 12
Relation between outpatient treatment of heart failure with proportion of hospitalization and mortality
Relate outpatient pharmacological treatment with the proportion of hospitalization and mortality
Measured: Baseline and at Month 12
Clinical and hemodynamic presentation of acutely decompensated heart failure
Describe the clinical and hemodynamic presentation of patients with acute decompensated heart failure
Measured: Baseline
In-hospital management of acutely decompensated heart failure
Describe the in-hospital management of patients with acutely decompensated heart failure
Measured: Baseline
Proportion of in-hospital mortality related with acute decompensation of heart failure
Determine the proportion of in-hospital mortality related with acute decompensation of heart failure
Measured: Baseline
Proportion of rehospitalization at 1, 6, 12 months after hospital discharge
Determine the proportion of rehospitalization at 1, 6 and 12 months after hospital discharge
Measured: Month 1, Month 6 and Month 12
Proportion of mortality at 1, 6, 12 months after hospital discharge
Determine the proportion of mortality at 1, 6 and 12 months after hospital discharge
Measured: 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
Relate the hemodynamic profile of decompensation with the proportion of in-hospital and ambulatory mortality at 1, 6 and 12 months after hospital discharge.
Measured: Baseline, Month 1, Month 6 and Month 12
Relation between in-hospital pharmacological treatment with mortality at 1, 6, 12 months after hospital discharge
Relate hospital pharmacological treatment with inpatient and outpatient mortality at 1, 6 and 12 months after hospital discharge.
Measured: 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
Relate hospital pharmacological treatment with the proportion of readmissions at 1, 6 and 12 months after hospital discharge.
Measured: 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
Relate outpatient pharmacological treatment with the proportion of hospitalization and mortality at 1, 6 and 12 months after hospital discharge.
Measured: Month 1, Month 6 and Month 12
Differences among heart failure treatment considering sociodemographic characteristics
Describe the differences among inpatient and outpatient treatment taking into account different demographic characteristics such as: gender, age, comorbidities, among others
Measured: Baseline
Differences among proportion of rehospitalization and heart failure mortality considering sociodemographic characteristics
Describe the differences in the proportion of rehospitalization, hospital and outpatient mortality, taking into account different demographic characteristics: gender, age, comorbidities, among others
Measured: Baseline
Differences among proportion of rehospitalization and heart failure mortality considering implementation of optimal medical treatment
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
Measured: Baseline, Month 1, Month 6 and Month 12
Differences among hospitalization and heart failure mortality considering the use of cardiac devices
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
Measured: Baseline, Month 1, Month 6 and Month 12
Cumulative heart failure survival and readmission-free survival
Evaluate cumulative survival and heart failure readmission-free survival
Measured: Baseline, Month 1, Month 6 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 Apr 2022
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,732 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Fundacion Clinica Valle del Lili
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedad Interamericana de Cardiología (SIAC), Consejo Interamericano de Falla Cardíaca e Hipertensión Pulmonar (CIFACAH)
- Responsible party
- Principal investigator, Juan Esteban Gomez, Fundacion Clinica Valle del Lili
- Investigators
- Juan E Gomez-Mesa, MD, Principal investigator, Fundacion Clinica Valle del LiliMario Speranza, MD, Principal investigator, Hospital Clínica BíblicaEduardo R. Perna, MD, Principal investigator, Instituto De Cardiología J. F. CabralVíctor A. Rossel, MD, Principal investigator, Instituto Nacional del TóraxDaniel Quesada, MD, Principal investigator, Hospital San Vicente de PaulMark H. Drazner, MD, Principal investigator, University of Texas Southwestern Medical CenterAlexander Romero, MD, Principal investigator, Hospital Santo TomasWalter Alarco, MD, Principal investigator, Instituto Nacional Cardiovascular INCOR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295641
- Sponsor's protocol ID
- FVL-1310
- Acronym
- AMERICCAASS
- Status last verified
- Apr 2025
- First submitted
- 15 Mar 2022
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share IPD, since we are not allowed to share information concerning medical history of our patients
Publications
Adams KF Jr, Fonarow GC, Emerman CL, LeJemtel TH, Costanzo MR, Abraham WT, Berkowitz RL, Galvao M, Horton DP; ADHERE Scientific Advisory Committee and Investigators. Characteristics and outcomes of patients hospitalized for heart failure in the United States: rationale, design, and preliminary observations from the first 100,000 cases in the Acute Decompensated Heart Failure National Registry (ADHERE). Am Heart J. 2005 Feb;149(2):209-16. doi: 10.1016/j.ahj.2004.08.005.
PubMed 15846257Jonsson A, Edner M, Alehagen U, Dahlstrom U. Heart failure registry: a valuable tool for improving the management of patients with heart failure. Eur J Heart Fail. 2010 Jan;12(1):25-31. doi: 10.1093/eurjhf/hfp175.
PubMed 20023041McMurray JJ, Stewart S. Epidemiology, aetiology, and prognosis of heart failure. Heart. 2000 May;83(5):596-602. doi: 10.1136/heart.83.5.596. No abstract available.
PubMed 10768918Mosterd A, Hoes AW. Clinical epidemiology of heart failure. Heart. 2007 Sep;93(9):1137-46. doi: 10.1136/hrt.2003.025270.
PubMed 17699180Hernandez-Leiva E. [Epidemiology of acute coronary syndrome and heart failure in Latin America]. Rev Esp Cardiol. 2011 Jul;64 Suppl 2:34-43. doi: 10.1016/j.recesp.2011.01.022. Spanish.
PubMed 21807285Bocchi EA, Arias A, Verdejo H, Diez M, Gomez E, Castro P; Interamerican Society of Cardiology. The reality of heart failure in Latin America. J Am Coll Cardiol. 2013 Sep 10;62(11):949-58. doi: 10.1016/j.jacc.2013.06.013. Epub 2013 Jul 10.
PubMed 23850910Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P. 2016 ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure. Rev Esp Cardiol (Engl Ed). 2016 Dec;69(12):1167. doi: 10.1016/j.rec.2016.11.005. No abstract available. English, Spanish.
PubMed 27894487O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Jan 29;61(4):e78-e140. doi: 10.1016/j.jacc.2012.11.019. Epub 2012 Dec 17. No abstract available.
PubMed 23256914Brouwers FP, de Boer RA, van der Harst P, Voors AA, Gansevoort RT, Bakker SJ, Hillege HL, van Veldhuisen DJ, van Gilst WH. Incidence and epidemiology of new onset heart failure with preserved vs. reduced ejection fraction in a community-based cohort: 11-year follow-up of PREVEND. Eur Heart J. 2013 May;34(19):1424-31. doi: 10.1093/eurheartj/eht066. Epub 2013 Mar 6.
PubMed 23470495Lam CS, Donal E, Kraigher-Krainer E, Vasan RS. Epidemiology and clinical course of heart failure with preserved ejection fraction. Eur J Heart Fail. 2011 Jan;13(1):18-28. doi: 10.1093/eurjhf/hfq121. Epub 2010 Aug 3.
PubMed 20685685Levy D, Kenchaiah S, Larson MG, Benjamin EJ, Kupka MJ, Ho KK, Murabito JM, Vasan RS. Long-term trends in the incidence of and survival with heart failure. N Engl J Med. 2002 Oct 31;347(18):1397-402. doi: 10.1056/NEJMoa020265.
PubMed 12409541Roger VL, Weston SA, Redfield MM, Hellermann-Homan JP, Killian J, Yawn BP, Jacobsen SJ. Trends in heart failure incidence and survival in a community-based population. JAMA. 2004 Jul 21;292(3):344-50. doi: 10.1001/jama.292.3.344.
PubMed 15265849Barker WH, Mullooly JP, Getchell W. Changing incidence and survival for heart failure in a well-defined older population, 1970-1974 and 1990-1994. Circulation. 2006 Feb 14;113(6):799-805. doi: 10.1161/CIRCULATIONAHA.104.492033. Epub 2006 Feb 6.
PubMed 16461823Jhund PS, Macintyre K, Simpson CR, Lewsey JD, Stewart S, Redpath A, Chalmers JW, Capewell S, McMurray JJ. Long-term trends in first hospitalization for heart failure and subsequent survival between 1986 and 2003: a population study of 5.1 million people. Circulation. 2009 Feb 3;119(4):515-23. doi: 10.1161/CIRCULATIONAHA.108.812172. Epub 2009 Jan 19.
PubMed 19153268Levy D, Larson MG, Vasan RS, Kannel WB, Ho KK. The progression from hypertension to congestive heart failure. JAMA. 1996 May 22-29;275(20):1557-62.
PubMed 8622246
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- American Registry of Ambulatory or Acutely Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT05295641
- Acronym / sponsor ID
- AMERICCAASS / FVL-1310
- Keywords
- Decompensated, Outpatient, Treatment, Hospitalization, Mortality, Heart Failure, Americas, Registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,732 participants (actual)
- Lead sponsor
- Fundacion Clinica Valle del LiliUniversity, hospital or other
- Collaborators
- Sociedad Interamericana de Cardiología (SIAC), Consejo Interamericano de Falla Cardíaca e Hipertensión Pulmonar (CIFACAH)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart failure patients with either ambulatory diagnosis or an acute decompensation
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characteristics of population with diagnosis of heart failure in America
Time frame: Baseline
Sociodemographic characteristics of patients with heart failure
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
16 secondary outcomes
Outpatient management of heart failure
Time frame: 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
Clinical and hemodynamic presentation of acutely decompensated heart failure
Time frame: Baseline
In-hospital management of acutely decompensated heart failure
Time frame: Baseline
Proportion of in-hospital mortality related with acute decompensation of heart failure
Time frame: Baseline
Proportion of rehospitalization at 1, 6, 12 months after hospital discharge
Time frame: 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
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
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
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
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
Differences among heart failure treatment considering sociodemographic characteristics
Time frame: Baseline
Differences among proportion of rehospitalization and heart failure mortality considering sociodemographic characteristics
Time frame: 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
Differences among hospitalization and heart failure mortality considering the use of cardiac devices
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Background: PubMed 15846257Adams KF Jr, Fonarow GC, Emerman CL, LeJemtel TH, Costanzo MR, Abraham WT, Berkowitz RL, Galvao M, Horton DP; ADHERE Scientific Advisory Committee and Investigators. Characteristics and outcomes of patients hospitalized for heart failure in the United States: rationale, design, and preliminary observations from the first 100,000 cases in the Acute Decompensated Heart Failure National Registry (ADHERE). Am Heart J. 2005 Feb;149(2):209-16. doi: 10.1016/j.ahj.2004.08.005.
- Background: PubMed 20023041Jonsson A, Edner M, Alehagen U, Dahlstrom U. Heart failure registry: a valuable tool for improving the management of patients with heart failure. Eur J Heart Fail. 2010 Jan;12(1):25-31. doi: 10.1093/eurjhf/hfp175.
- Background: PubMed 10768918McMurray JJ, Stewart S. Epidemiology, aetiology, and prognosis of heart failure. Heart. 2000 May;83(5):596-602. doi: 10.1136/heart.83.5.596. No abstract available.
- Background: PubMed 17699180Mosterd A, Hoes AW. Clinical epidemiology of heart failure. Heart. 2007 Sep;93(9):1137-46. doi: 10.1136/hrt.2003.025270.
- Background: PubMed 21807285Hernandez-Leiva E. [Epidemiology of acute coronary syndrome and heart failure in Latin America]. Rev Esp Cardiol. 2011 Jul;64 Suppl 2:34-43. doi: 10.1016/j.recesp.2011.01.022. Spanish.
- Background: PubMed 23850910Bocchi EA, Arias A, Verdejo H, Diez M, Gomez E, Castro P; Interamerican Society of Cardiology. The reality of heart failure in Latin America. J Am Coll Cardiol. 2013 Sep 10;62(11):949-58. doi: 10.1016/j.jacc.2013.06.013. Epub 2013 Jul 10.
- Background: PubMed 27894487Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P. 2016 ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure. Rev Esp Cardiol (Engl Ed). 2016 Dec;69(12):1167. doi: 10.1016/j.rec.2016.11.005. No abstract available. English, Spanish.
- Background: PubMed 23256914O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Jan 29;61(4):e78-e140. doi: 10.1016/j.jacc.2012.11.019. Epub 2012 Dec 17. No abstract available.
- Background: PubMed 23470495Brouwers FP, de Boer RA, van der Harst P, Voors AA, Gansevoort RT, Bakker SJ, Hillege HL, van Veldhuisen DJ, van Gilst WH. Incidence and epidemiology of new onset heart failure with preserved vs. reduced ejection fraction in a community-based cohort: 11-year follow-up of PREVEND. Eur Heart J. 2013 May;34(19):1424-31. doi: 10.1093/eurheartj/eht066. Epub 2013 Mar 6.
- Background: PubMed 20685685Lam CS, Donal E, Kraigher-Krainer E, Vasan RS. Epidemiology and clinical course of heart failure with preserved ejection fraction. Eur J Heart Fail. 2011 Jan;13(1):18-28. doi: 10.1093/eurjhf/hfq121. Epub 2010 Aug 3.
- Background: PubMed 12409541Levy D, Kenchaiah S, Larson MG, Benjamin EJ, Kupka MJ, Ho KK, Murabito JM, Vasan RS. Long-term trends in the incidence of and survival with heart failure. N Engl J Med. 2002 Oct 31;347(18):1397-402. doi: 10.1056/NEJMoa020265.
- Background: PubMed 15265849Roger VL, Weston SA, Redfield MM, Hellermann-Homan JP, Killian J, Yawn BP, Jacobsen SJ. Trends in heart failure incidence and survival in a community-based population. JAMA. 2004 Jul 21;292(3):344-50. doi: 10.1001/jama.292.3.344.
- Individual participant dataSharing planned: No. We do not plan to share IPD, since we are not allowed to share information concerning medical history of our patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan E Gomez-Mesa, MD principal investigator
Fundacion Clinica Valle del Lili
Mario Speranza, MD principal investigator
Hospital Clínica Bíblica
Eduardo R. Perna, MD principal investigator
Instituto De Cardiología J. F. Cabral
119 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Acute Heart Failure (AHF), run by Fundacion Clinica Valle del Lili at 119 sites in 21 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 119 sites in Colombia, Cuba, Argentina, Ecuador, Venezuela and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristics of population with diagnosis of heart failure in America (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05295641, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.