Heart Failure Cardiovascular Diseases
Conditions
Interventions
This is a prospective, randomized, controlled, pragmatic, multicenter, open-label clinical trial with blinded outcome assessment. A total of 400 adult participants aged 18 years or older with heart fa
Sponsors
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adults aged 18 years or older; diagnosis of heart failure with reduced ejection fraction below 40%; patients after hospital discharge, emergency department visit, day-hospital care or outpatient follow-up without optimized pharmacological treatment; access to a communication system that allows teleconsultations and telemonitoring; ability to understand the study procedures and provide written informed consent
Exclusion criteria
Exclusion criteria: Infiltrative or storage diseases, including amyloidosis; hypertrophic cardiomyopathy; primary valvular heart disease; congenital heart disease; pericardial disease; planned cardiovascular intervention or major surgery during the follow-up period; systemic disease with life expectancy shorter than 12 months; active systemic infection; alcohol or drug abuse; psychiatric disorders limiting study participation; untreated or uncontrolled thyroid disease; uncontrolled diabetes mellitus; chronic pulmonary embolism; unstable or oxygen-dependent chronic obstructive pulmonary disease; requirement for continuous intravenous inotropic therapy; indication for heart transplantation, left ventricular assist device or cardiac resynchronization therapy; systolic blood pressure below 90 millimeters of mercury or symptomatic hypotension; serum potassium concentration greater than 5.5 millimoles per liter; untreated arrhythmias or severe cardiac conduction disorders; estimated glomerular filtration rate below 20 milliliters per minute per 1.73 square meters; pregnancy or breastfeeding; inability to comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the proportion of participants achieving optimized pharmacological treatment for heart failure with reduced ejection fraction, defined as the use of at least three medication classes recommended by clinical guidelines and achievement of at least 75% of the recommended target dose according to individual clinical tolerance, assessed through medical prescriptions and clinical records at baseline and after six months of follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of participants with all-cause hospital readmission will be assessed through medical records during the six-month follow-up;Time to first all-cause hospital readmission will be assessed in days from randomization to the first readmission during the six-month follow-up;All-cause mortality will be assessed by the proportion of deaths from any cause recorded during the six-month follow-up;Cardiovascular mortality will be assessed by the proportion of deaths attributed to cardiovascular causes during the six-month follow-up;Functional status will be assessed according to the New York Heart Association functional classification at baseline and after six months of follow-up;Quality of life will be assessed using the Kansas City Cardiomyopathy Questionnaire score at baseline and after six months of follow-up | — |
Countries
BR
Contacts
Public ContactEdimar Bocchi
Instituto do Coração (INCOR) - Faculdade de Medicina da Universidade de São Paulo (FMUSP)
Outcome results
None listed