Left-side heart failure
Conditions
Interventions
60 ambulatorial patients will be randomized 1:1 by independent random sample to either keep standard heart failure treatment (control group) or have renin-angiotensin-system inhibitors and neprilisin
if daily dose is above those values, medications will have daily dose reduced by half, and, after two teeks, they will be suspended. After this, angiotensin-converting enzyme inhibitors or angiotensin
D02.033.100.624.151
Sponsors
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with previous diagnosis of reduced ejection fraction heart failure and documented ejection fraction equal or under 40% and actual ejection fraction equal or more than 50% and 10% greater than previous; Age equal or greater than 18 years old; absence of symptoms related to heart failure; Currently using carvedilol and angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers or neprilisin inhibitor with or without spironolactone; NT-proBNP under 250pg/mL; heart rate between 50 and 60 or maximum tolerated dose of carvedilol after runin fase or at least 50mg/day of carvedilol.
Exclusion criteria
Exclusion criteria: Ischemic cardiomyopathy; hypertensive cardiomyopathy: stage 3 hypertension as defined by the Brazilian Guideline of Hypertension or current blood pressure higher than 160x90mmHg; chagasic cardiomyopathy; valvar cardiomyopathy; infiltrative cardiomyopathy; chronic renal disease with creatinine clearance less than 30mL/min/1,73m²; formal indication for angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers such as diabetic patients with hypertension, diabetic nephropathy or another nephropathy with proteinuria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate relapse of ventricular dysfunction in 6 months. We will consider a positive outcome if the patient fulfill one of the following criteria: reduction in left ventricular ejection fraction by more than 10% to less than 50% using transthoracic echocardiogram; an increase in left ventricular end diastolic volume indexed to body surface area by more than 10% and to higher the normal range using transthoracic echocardiogram; a 100% increase in N-terminal pro-brain natriuretic peptide to more than 400pg/mL; or clinical evidence of heart failure | — |
Secondary
| Measure | Time frame |
|---|---|
| We will evaluate mortality in 24 weeks;We will evaluate if hospitalization due to decompensated heart failure will happen ;We will evaluate occurrence of sustained supraventricular and ventricular arrhythmias using clinical evaluation;We will evaluate echocardiographic parameters using transthoracic echocardiogram: left atrial volume and size, left ventricular systolic and diastolic diameters, diastolic left ventricular function, right ventricular function, presence and graduation of valvar insufficiencies, systolic pulmonary artery pressure, contractility score of left ventricular function in a 17 segments model ;We will evaluate quality of life using the validated by Minnesota Living with Heart Failure Questionnaire;Peak oxygen uptake value in ergospirometry in milliliters per kilogram per minute;Evaluation of distance in meters achieved in 6-minute walk test ;We will evaluate heart rate in beats per minute and blood pressure in millimeters of mercury;We will evaluate medication adherence by the questionnaire used in Repetitive Education and Monitoring for ADherence for Heart Failure study | — |
Countries
Brazil
Contacts
Public ContactDeborah Belfort
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed