AMERICCAASS: American Registry of Ambulatory or Acute Decompensated Heart Failure

Sponsor

Fundacion Clinica Valle del Lili (Other)

Overall Status

Recruiting

CT.gov ID

NCT05295641

Collaborator

Sociedad Interamericana de Cardiología (SIAC) (Other), Consejo Interamericano de Falla Cardíaca e Hipertensión Pulmonar (CIFACAH) (Other)

1,380

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to better characterize and understand the population of patients with ambulatory or acutely decompensated heart failure in the American continent, getting to know their sociodemographic, clinical and paraclinical characteristics

Condition or Disease	Intervention/Treatment	Phase
Heart Failure

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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1380 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

American Registry of Ambulatory or Acute Decompensated Heart Failure

Actual Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Outcome Measures

Primary Outcome Measures

Characteristics of population with diagnosis of heart failure in America [Baseline]
Sociodemographic characteristics of patients with heart failure
Characteristics of population with diagnosis of heart failure in America [Baseline, at Month 1, Month 6 and Month 12]
Clinical and paraclinical characteristics of patients with heart failure

Secondary Outcome Measures

Outpatient management of heart failure [Baseline and at Month 12]
Describe the ambulatory/outpatient management of patients with heart failure
Relation between outpatient treatment of heart failure with proportion of hospitalization and mortality [Baseline and at Month 12]
Relate outpatient pharmacological treatment with the proportion of hospitalization and mortality
Clinical and hemodynamic presentation of acutely decompensated heart failure [Baseline]
Describe the clinical and hemodynamic presentation of patients with acute decompensated heart failure
In-hospital management of acutely decompensated heart failure [Baseline]
Describe the in-hospital management of patients with acutely decompensated heart failure
Proportion of in-hospital mortality related with acute decompensation of heart failure [Baseline]
Determine the proportion of in-hospital mortality related with acute decompensation of heart failure
Proportion of rehospitalization at 1, 6, 12 months after hospital discharge [Month 1, Month 6 and Month 12]
Determine the proportion of rehospitalization at 1, 6 and 12 months after hospital discharge
Proportion of mortality at 1, 6, 12 months after hospital discharge [Month 1, Month 6 and Month 12]
Determine the proportion of mortality at 1, 6 and 12 months after hospital discharge
Relation between hemodynamic profile of decompensation with proportion of mortality at 1, 6, 12 months after hospital discharge [Baseline, Month 1, Month 6 and Month 12]
Relate the hemodynamic profile of decompensation with the proportion of in-hospital and ambulatory mortality at 1, 6 and 12 months after hospital discharge.
Relation between in-hospital pharmacological treatment with mortality at 1, 6, 12 months after hospital discharge [Month 1, Month 6 and Month 12]
Relate hospital pharmacological treatment with inpatient and outpatient mortality at 1, 6 and 12 months after hospital discharge.
Relation between in-hospital pharmacological treatment with proportion of readmissions at 1, 6, 12 months after hospital discharge [Month 1, Month 6 and Month 12]
Relate hospital pharmacological treatment with the proportion of readmissions at 1, 6 and 12 months after hospital discharge.
Relation between outpatient pharmacological treatment with proportion of hospitalization and mortality at 1, 6, 12 months after hospital discharge [Month 1, Month 6 and Month 12]
Relate outpatient pharmacological treatment with the proportion of hospitalization and mortality at 1, 6 and 12 months after hospital discharge.
Differences among heart failure treatment considering sociodemographic characteristics [Baseline]
Describe the differences among inpatient and outpatient treatment taking into account different demographic characteristics such as: gender, age, comorbidities, among others
Differences among proportion of rehospitalization and heart failure mortality considering sociodemographic characteristics [Baseline]
Describe the differences in the proportion of rehospitalization, hospital and outpatient mortality, taking into account different demographic characteristics: gender, age, comorbidities, among others
Differences among proportion of rehospitalization and heart failure mortality considering implementation of optimal medical treatment [Baseline, Month 1, Month 6 and Month 12]
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
Differences among hospitalization and heart failure mortality considering the use of cardiac devices [Baseline, Month 1, Month 6 and Month 12]
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
Cumulative heart failure survival and readmission-free survival [Baseline, Month 1, Month 6 and Month 12]
Evaluate cumulative survival and heart failure readmission-free survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinica Cardio VID	Medellín	Antioquia	Colombia	050001
2	Sociedad Clínica Iberoamericanas.	Barranquilla	Atlantico	Colombia	08000
3	Clínica Medilaser Florencia	Florencia	Caquetá	Colombia	180001-180009
4	Clínica del Occidente	Bogotá	Cundinamarca	Colombia	110851
5	Clínica los Rosales S.A. - Centro Médico para el Corazón	Pereira	Risaralda	Colombia	660003
6	Fundación Valle del Lili	Santiago de Cali	Valle	Colombia	760032
7	Instituto de Cardiología y Cirugía Cardiovascular	La Habana	Departamento Occidental	Cuba	10000-19999
8	Hospital Regional Presidente Estrella Ureña	Santiago De Los Caballeros	Santiago	Dominican Republic	51000
9	Hospital Luis Vernaza	Guayaquil	Guayas	Ecuador	090101 - 090158
10	Centro Médico de Especialidades Ameds	Manta	Manabí	Ecuador	EC130850
11	HOSPICOR	Manta	Manabí	Ecuador	EC130850
12	Centro Cardiológico A.C.I	Portoviejo	Manabí	Ecuador	EC130150
13	Hospital Metropolitano	Quito	Pichincha	Ecuador	EC170150
14	Clínica de Cardiología y Ortopedia CCO	San Salvador		El Salvador
15	Instituto Salvadoreño del Seguro Social	San Salvador		El Salvador
16	Hospital General San Juan de Dios	Ciudad de Guatemala		Guatemala	1001 - 1073
17	Hospital Roosevelt	Ciudad de Guatemala		Guatemala	1001 - 1073
18	Clínicas HART y Hospital Regional de Occidente	Quetzaltenango		Guatemala	09001
19	Christus Muguerza Hospital Alta Especialidad	Monterrey	Nuevo León	Mexico	64000
20	Centenario Hospital Miguel Hidalgo	Aguascalientes		Mexico	20000 - 20999
21	Hospital Español. Sociedad de Beneficencia Española I.A.P	Ciudad de México		Mexico	01000-16999
22	Hospital Nacional de Itaugua	Itauguá	Central	Paraguay	2740
23	Hospital Central - Instituto de Previsión Social	Asunción		Paraguay	1001-1925
24	Instituto Nacional de Cardiología "Prof. Dr. Juan A. Catonni"	Asunción		Paraguay	1001-1925
25	Hospital III EsSalud Chimbote	Chimbote	Áncash	Peru
26	Thorax Centrum Paramaribo /Academic Hospital Paramaribo	Paramaribo		Suriname
27	Clínica Chilemex	Puerto Ordaz	Bolívar	Venezuela	8050
28	Centro Policlínico Valencia	Valencia	Carabobo	Venezuela	2001
29	ASCARDIO	Barquisimeto	Lara	Venezuela	3001
30	Instituto Autónomo Hospital Universitario de Los Andes	Mérida		Venezuela	5101