OPTIMUM Study of Remote Patient Monitoring in Ambulatory Heart Failure Care
NCT07439081
Acute Heart Failure (AHF), Cardiovascular Diseases
Lyon, Auvergne-Rhône-Alpes, France
View Trial DetailsNCT Number: NCT05295641
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
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Notify Me18 year and older
All sexes
Observational
Sanatorio Modelo Quilmes, Quilmes, Buenos Aires, Argentina
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
Sociodemographic characteristics of patients with heart failure
Time frame: Baseline, at Month 1, Month 6 and Month 12
Clinical and paraclinical characteristics of patients with heart failure
Time frame: Baseline and at Month 12
Describe the ambulatory/outpatient management of patients with heart failure
Time frame: Baseline and at Month 12
Relate outpatient pharmacological treatment with the proportion of hospitalization and mortality
Time frame: Baseline
Describe the clinical and hemodynamic presentation of patients with acute decompensated heart failure
Time frame: Baseline
Describe the in-hospital management of patients with acutely decompensated heart failure
Time frame: Baseline
Determine the proportion of in-hospital mortality related with acute decompensation of heart failure
Time frame: Month 1, Month 6 and Month 12
Determine the proportion of rehospitalization at 1, 6 and 12 months after hospital discharge
Time frame: Month 1, Month 6 and Month 12
Determine the proportion of mortality at 1, 6 and 12 months after hospital discharge
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Describe the differences among inpatient and outpatient treatment taking into account different demographic characteristics such as: gender, age, comorbidities, among others
Time frame: Baseline
Describe the differences in the proportion of rehospitalization, hospital and outpatient mortality, taking into account different demographic characteristics: gender, age, comorbidities, among others
Time frame: 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
Time frame: 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
Time frame: Baseline, Month 1, Month 6 and Month 12
Evaluate cumulative survival and heart failure readmission-free survival
Fundacion Clinica Valle del Lili
Other
Acronym: AMERICCAASS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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