The present study aims to evaluate the antihypertensive effect of sacubitril/valsartan in patients with resistant hypertension compared to the use of recommended and optimized antihypertensive therapy, through a randomized clinical trial, over 12 weeks.
Worldwide, millions of people are affected by the arterial hypertension system (SAH), so that the presence of resistant hypertension (RH) significantly influences a high cardiovascular morbidity and mortality compared to those with controlled SAH, thus corroborating the need for the development of agents antihypertensive drugs with favorable efficacy and safety profiles. It is known that they are currently using the combined therapy recommended for this group of patients, among them, a significant portion of individuals with RH are unable to achieve the goal of BP control (\>140/90 mmHg) even though in regular use, being subject to the greatest risk of cardiovascular outcomes and morbidity and mortality. Approved by the FDA for use in heart failure with reduced ejection fraction with beneficial effects on morbidity and mortality, identified in previous studies, the sacubitril/valsartan molecule (LCZ696) or Entresto® is a molecular complex composed of the sacubitril prodrug activated after ingestion in sacubitrilate - neprilysin inhibitor - associated with valsartan, an angiotensin II type-1 (AT1) receptor antagonist, with vasodilating action, capable of reducing BP, sympathetic tone, with antifibrotic and anti-hypertrophic effects, in addition to natriuresis and diuresis. Considering the knowledge gap to the benefits to LCZ696 in the control of blood pressure in resistant hypertension, the objective of the present study is to evaluate the efficacy (reduction of ambulatory systolic and diastolic blood pressure) and safety (adverse events, hospitalization and cardiovascular death) of the use of sacubitril/valsartan in comparison to the antihypertensive therapy recommended and optimized by the current guidelines, in patients diagnosed with RH, over12 weeks, through a randomized clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Use of sacubitril/valsartan after suspension of ACE inhibitors or ARBs.
General Hospital Roberto Santos
Salvador, Estado de Bahia, Brazil
Hospital Universitário Professor Edgard Santos
Salvador, Estado de Bahia, Brazil
achieving the blood pressure target of <140/90mmg and the reducing of the mean sitting systolic blood pressure (msSBP), mean sitting diastolic blood pressure (msDBP), and mean sitting pulse pressure (msPP) over an 8-week period.
2 co-primary outcomes
Time frame: 8 weeks
Secondary efficacy outcomes included BP reduction stratified by Sac-Val dose compared to standard therapy.
Secondary outcome
Time frame: 8 weeks
Secondary safety outcomes included incidence of acute myocardial infarction, hospitalization, stroke, hypotension, angioedema, electrolyte disturbances, CKD progression, and CV mortality
Safety outcomes
Time frame: 8 weeks
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