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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05295641
Other study ID # FVL-1310
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 1, 2022
Est. completion date June 2024

Study information

Verified date June 2024
Source Fundacion Clinica Valle del Lili
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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


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 information / eligibility

Status Active, not recruiting
Enrollment 6679
Est. completion date June 2024
Est. primary completion date November 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
Argentina Hospital General de Agudos Carlos G. Durand Buenos Aires
Argentina Sanatorio Santa Clara Talar Buenos Aires
Argentina Hospital Italiano de Córdoba Córdoba
Argentina Hospital Privado Universitario de Córdoba Córdoba
Argentina Instituto Modelo de Cardiología Privado SRL Córdoba
Argentina Instituto de Cardiología Juana Francisca Cabral Bolívar Corrientes
Argentina Clinica Vrsalovic / Clinica del Angelo Formosa
Argentina Sanatorio de la Trinidad Quilmes y Centro Gallego Quilmes Buenos Aires
Argentina Sanatorio Modelo Quilmes Quilmes Buenos Aires
Argentina Instituto Cardiovascular del Rosario Rosario Santa Fé
Argentina Hospital San Bernardo Salta
Argentina Clínica El Castaño - CIMAC San Juan
Argentina Hospital Descentralizado Dr. Guillermo Rawson San Juan
Argentina Hospital Público Dr. Marcial V. Quiroga San Juan
Argentina Clínica CERHU / Hospital Central Ramón Carrillo San Luis
Argentina Establecimiento Asistencial Gobernador Centeno Santa Rosa La Pampa
Bolivia Caja Petrolera de Salud Santa Cruz de la Sierra
Bolivia Hospital Universitario Japonés Santa Cruz de la Sierra Santa Cruz
Chile Instituto Nacional del Tórax Santiago
Colombia Clínica General del Norte Barranquilla
Colombia Sociedad Clínica Iberoamericana Barranquilla Atlantico
Colombia Clínica del Occidente Bogotá Cundinamarca
Colombia Fundación Cardioinfantil Bogotá Cundinamarca
Colombia Fundación Santa Fé de Bogotá Bogotá Cundinamarca
Colombia Hospital Santa Clara Bogotá
Colombia Clínica Medilaser Florencia Florencia Caquetá
Colombia Fundación Cardiovascular de Colombia Floridablanca Santander
Colombia Clinica Avidanti S.A.S Ibagué Tolima
Colombia Instituto Todo Por El Corazón Manizales Caldas
Colombia Clinica Cardio VID Medellín Antioquia
Colombia Hospicardio Montería Córdoba
Colombia Unimedic Ips Pasto Nariño
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 Sociedad Cardiológica Colombiana S.A.S. Villavicencio
Costa Rica Hospital San Vicente de Paúl Heredia
Costa Rica Hospital Clínica Bíblica San José
Costa Rica Hospital México, CCSS San José
Cuba Hospital Provincial Clínico Quirúrgico Docente Carlos Manuel De Céspedes Bayamo
Cuba Hospital Provincial Clínico Quirúrgico Docente Manuel Ascunce Domenech Camagüey
Cuba Hospital Provincial Dr. Antonio Luaces Iraola Ciego De Ávila
Cuba Hospital General Orlando Pantoja Tamayo Contramaestre
Cuba Hospital Clínico Quirúrgico Docente Calixto García Íñiguez La Habana
Cuba Hospital Clínico Quirúrgico Docente Dr. Enrique Cabrera La Habana
Cuba Hospital Provincial Camilo Cienfuegos La Habana
Cuba Instituto de Cardiología y Cirugía Cardiovascular La Habana Departamento Occidental
Cuba Hospital General Docente Dr. Ernesto Guevara De La Serna Las Tunas
Cuba Hospital Provincial Clínico Quirúrgico Docente Cmte. Faustino Pérez Matanzas
Cuba Hospital Clínico Quirúrgico Docente Héroes Del Baire Nueva Gerona
Cuba Hospital Provincial Docente Marting Chang Puga Nuevitas
Cuba Hospital Provincial Clinico Quirurgico Docente Leon Cuervo Rubio Pinar del Rio
Cuba Hospital Provincial Clínico Quirúrgico Docente Abel Santamaría Pinar Del Río
Cuba Hospital Clinico Quirurgico Docente Ivan Portuondo San Antonio de los Baños Artemisa
Cuba Cardiocentro Santiago de Cuba Santiago de Cuba
Cuba Hospital Provincial Saturnino Lora Santiago de Cuba
Dominican Republic Centro Médico Siglo 21 San Francisco de Macoris
Dominican Republic Clínica Universitaria Unión Médica del Norte Santiago De Los Caballeros Santiago
Dominican Republic Hospital Metropolitano de Santiago Homs Santiago De Los Caballeros
Dominican Republic Hospital Regional Presidente Estrella Ureña Santiago De Los Caballeros Santiago
Ecuador Hospital José Carrasco Arteaga / Instituto ecuatoriano de seguridad social Cuenca
Ecuador Hospital Clínica Kennedy Guayaquil Guayas
Ecuador Hospital Luis Vernaza Guayaquil Guayas
Ecuador Clinica Jesús De Nazareth / Hospital San Marcos Machala
Ecuador Centro Médico de Especialidades Ameds Manta Manabí
Ecuador HOSPICOR Manta Manabí
Ecuador Centro Cardiológico A.C.I Portoviejo Manabí
Ecuador Hospital General EISS Portoviejo Portoviejo
Ecuador Hospital Metropolitano Quito Pichincha
Ecuador Centro De Diagnóstico Y Tratamiento De Enfermedades (Cdt) Cardiovasculares Cardioheredia Samborondón
El Salvador Clínica de Cardiología y Ortopedia CCO San Salvador
El Salvador Clínica del Corazón Sinusal San Salvador
El Salvador Instituto Salvadoreño del Seguro Social San Salvador
Guatemala Cardiocentro Chimaltenango Chimaltenango
Guatemala Hospital General San Juan de Dios Ciudad de Guatemala
Guatemala Hospital Roosevelt Ciudad de Guatemala
Guatemala Clínicas HART y Hospital Regional de Occidente Quetzaltenango
Guatemala Hospital Regional de Zacapa Zacapa
Honduras Cardio Medical Center Tegucigalpa Francisco Morazán
Honduras Instituto Nacional Cardiopulmonar Tegucigalpa Francisco Morazán
Jamaica Heart institute of the caribbean Kingston
Mexico Centenario Hospital Miguel Hidalgo Aguascalientes
Mexico Hospital Español. Sociedad de Beneficencia Española I.A.P Ciudad de México
Mexico Instituto Nacional de Cardiología Ignacio Chávez Ciudad de México
Mexico Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran Ciudad de México
Mexico Servicios Profesionales Del Sagrado Corazón De Jesús S.C. Ciudad de México
Mexico Christus Muguerza Hospital Alta Especialidad Monterrey Nuevo León
Mexico TecSalud, Escuela de Medicina y Ciencias de la Salud del ITESM Monterrey
Nicaragua Hospital Carlos R Huembes/Clinica Plaza España/Clinica Centro Medico Juigalpa Managua
Panama Hospital Santo Tomás Ciudad de Panamá
Paraguay Hospital Central - Instituto de Previsión Social Asunción
Paraguay Instituto Cardiovascular del Sanatorio Migone Asunción
Paraguay Instituto Nacional de Cardiología "Prof. Dr. Juan A. Catonni" Asunción
Paraguay Sanatorio Adventista de Asunción Asunción
Paraguay Sanatorio Italiano Asunción
Paraguay Clinicor Estudios Cardiológicos Concepción
Paraguay Hospital Nacional de Itaugua Itauguá Central
Paraguay Hospital de Clínicas - Facultad de ciencias médicas San Lorenzo
Peru Luis Heysen Inchaustegui - ESSALUD Chiclayo
Peru Hospital III EsSalud Chimbote Chimbote Áncash
Peru Hospital María Auxiliadora Lima
Peru Hospital Nacional Arzobispo Loayza Lima
Peru Hospital Nacional Daniel Alcides Carrión Lima
Peru Instituto Cardiovascular Clinicor Norte Lima
Suriname Thorax Centrum Paramaribo /Academic Hospital Paramaribo Paramaribo
United States University of Texas Southwestern Medical Center Dallas Texas
United States North Shore University Hospital, Nothwell Health Manhasset New York
Uruguay Hospital de Clínicas Doctor Manuel Quintela Montevideo
Uruguay Médica Uruguaya Montevideo
Venezuela Cardiología Tropical Azoátegui Anzoátegui
Venezuela ASCARDIO Barquisimeto Lara
Venezuela Atimed C.A Cumaná
Venezuela Centro Clinico Santa Rosa Cumaná Sucre
Venezuela Instituto Autónomo Hospital Universitario de Los Andes Mérida
Venezuela Unidad Cardiovascular Ferrer Puerto Cabello Carabobo
Venezuela Clínica Chilemex Puerto Ordaz Bolívar
Venezuela IVSS Hospital Dr. Rafael Calles Sierra Punto Fijo
Venezuela Centro Policlínico Valencia Valencia Carabobo
Venezuela Unicor/Funvic Valencia

Sponsors (3)

Lead Sponsor Collaborator
Fundacion Clinica Valle del Lili Consejo Interamericano de Falla Cardíaca e Hipertensión Pulmonar (CIFACAH), Sociedad Interamericana de Cardiología (SIAC)

Countries where clinical trial is conducted

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

References & Publications (23)

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. — View Citation

Barker 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. — View Citation

Bocchi 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. — View Citation

Brouwers 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. — View Citation

Gheorghiade M, Bonow RO. Chronic heart failure in the United States: a manifestation of coronary artery disease. Circulation. 1998 Jan 27;97(3):282-9. doi: 10.1161/01.cir.97.3.282. No abstract available. — View Citation

He J, Ogden LG, Bazzano LA, Vupputuri S, Loria C, Whelton PK. Risk factors for congestive heart failure in US men and women: NHANES I epidemiologic follow-up study. Arch Intern Med. 2001 Apr 9;161(7):996-1002. doi: 10.1001/archinte.161.7.996. — View Citation

Hernandez-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. — View Citation

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. — View Citation

Jhund 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. — View Citation

Jonsson 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. — View Citation

Kannel WB, Ho K, Thom T. Changing epidemiological features of cardiac failure. Br Heart J. 1994 Aug;72(2 Suppl):S3-9. doi: 10.1136/hrt.72.2_suppl.s3. No abstract available. — View Citation

Killip T 3rd, Kimball JT. Treatment of myocardial infarction in a coronary care unit. A two year experience with 250 patients. Am J Cardiol. 1967 Oct;20(4):457-64. doi: 10.1016/0002-9149(67)90023-9. No abstract available. — View Citation

Lam 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. — View Citation

Levy 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. — View Citation

Levy 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. — View Citation

McMurray 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. — View Citation

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. — View Citation

Meyer P, Ekundayo OJ, Adamopoulos C, Mujib M, Aban I, White M, Aronow WS, Ahmed A. A propensity-matched study of elevated jugular venous pressure and outcomes in chronic heart failure. Am J Cardiol. 2009 Mar 15;103(6):839-44. doi: 10.1016/j.amjcard.2008.11.045. — View Citation

Mosterd A, Hoes AW. Clinical epidemiology of heart failure. Heart. 2007 Sep;93(9):1137-46. doi: 10.1136/hrt.2003.025270. — View Citation

O'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. — View Citation

Ponikowski 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. Erratum In: Rev Esp Cardiol (Engl Ed). 2017 Apr;70(4):309-310. English, Spanish. — View Citation

Roger 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. — View Citation

Schmidt DE, Shah PK. Accurate detection of elevated left ventricular filling pressure by a simplified bedside application of the Valsalva maneuver. Am J Cardiol. 1993 Feb 15;71(5):462-5. doi: 10.1016/0002-9149(93)90458-o. No abstract available. — View Citation

* Note: There are 23 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Characteristics of population with diagnosis of heart failure in America Sociodemographic characteristics of patients with heart failure Baseline
Primary 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 Outpatient management of heart failure Describe the ambulatory/outpatient management of patients with heart failure Baseline and at Month 12
Secondary Relation between outpatient treatment of heart failure with proportion of hospitalization and mortality Relate outpatient pharmacological treatment with the proportion of hospitalization and mortality Baseline and at Month 12
Secondary Clinical and hemodynamic presentation of acutely decompensated heart failure Describe the clinical and hemodynamic presentation of patients with acute decompensated heart failure Baseline
Secondary In-hospital management of acutely decompensated heart failure Describe the in-hospital management of patients with acutely decompensated heart failure Baseline
Secondary 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 Baseline
Secondary 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 Month 1, Month 6 and Month 12
Secondary 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 Month 1, Month 6 and Month 12
Secondary 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. Baseline, Month 1, Month 6 and Month 12
Secondary 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. Month 1, Month 6 and Month 12
Secondary 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. Month 1, Month 6 and Month 12
Secondary 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. Month 1, Month 6 and Month 12
Secondary 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 Baseline
Secondary 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 Baseline
Secondary 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 Baseline, Month 1, Month 6 and Month 12
Secondary 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 Baseline, Month 1, Month 6 and Month 12
Secondary Cumulative heart failure survival and readmission-free survival Evaluate cumulative survival and heart failure readmission-free survival Baseline, Month 1, Month 6 and Month 12
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