American Registry of Ambulatory or Acute Decompensated Heart Failure

Heart Failure Clinical Trial

— AMERICCAASS  

Official title:

American Registry of Ambulatory or Acute Decompensated Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05295641
• Other study ID #: FVL-1310
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: June 2024

Study information

• Verified date: October 2022
• Source: Fundacion Clinica Valle del Lili
• Contact: Juan E Gomez-Mesa, MD
• Phone: 3319090
• Email: juan.gomez.me[@]fvl.org.co
• Is FDA regulated: No
• 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: Recruiting
• Enrollment: 1380
• 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.)

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Argentina	Centro Médico Talar	Buenos Aires
Argentina	Hospital Italiano de Córdoba	Córdoba
Argentina	Hospital Privado Universitario de Córdoba	Córdoba
Argentina	Instituto de Cardiología Juana Francisca Cabral Bolívar	Corrientes
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
Colombia	Sociedad Clínica Iberoamericanas.	Barranquilla	Atlantico
Colombia	Clínica del Occidente	Bogotá	Cundinamarca
Colombia	Fundación Cardioinfantil	Bogotá	Cundinamarca
Colombia	Fundación Santa Fé de Bogotá	Bogotá	Cundinamarca
Colombia	Clínica Medilaser Florencia	Florencia	Caquetá
Colombia	Fundación Cardiovascular de Colombia	Floridablanca	Santander
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
Costa Rica	Hospital San Vicente de Paúl	Heredia
Costa Rica	Hospital México, CCSS	San José
Costa Rica	Hospital San Juan de Dios	San José
Cuba	Instituto de Cardiología y Cirugía Cardiovascular	La Habana	Departamento Occidental
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	Centro Médico de Especialidades Ameds	Manta	Manabí
Ecuador	HOSPICOR	Manta	Manabí
Ecuador	Centro Cardiológico A.C.I	Portoviejo	Manabí
Ecuador	Hospital Metropolitano	Quito	Pichincha
El Salvador	Clínica de Cardiología y Ortopedia CCO	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	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	Clinicor Estudios Cardiológicos	Concepción
Paraguay	Hospital Nacional de Itaugua	Itauguá	Central
Paraguay	Hospital de Clínicas - Facultad de ciencias médicas	San Lorenzo
Peru	Hospital III EsSalud Chimbote	Chimbote	Áncash
Peru	Hospital María Auxiliadora	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
Venezuela	Cardiología Tropical Azoátegui	Anzoátegui
Venezuela	ASCARDIO	Barquisimeto	Lara
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	Centro Policlínico Valencia	Valencia	Carabobo

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,  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 all — Click 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