Sacubitril/Valsartan in Resistant Hypertension

Last updated: February 20, 2025
Sponsor: Hospital Geral Roberto Santos
Overall Status: Completed

Phase

2

Condition

Williams Syndrome

Diabetes And Hypertension

Circulation Disorders

Treatment

Sacubitril-Valsartan

Clinical Study ID

NCT04637152
HGeralRobertoSantos
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men or women, over 18;

  • Diagnosed with resistant hypertension (using three or more antihypertensive agentsof different classes - eg. angiotensin-converting enzyme inhibitor, angiotensin IIreceptor blocker, calcium channel blockers, loop and thiazide diuretics orpotassium-sparing diuretics), at least 4 weeks before recruitment, with a BP thatremains above the goal of 140/90 mmHg.

Exclusion

Exclusion Criteria:

  • Secondary and treatable hypertension;

  • History of angioedema; significant cerebrovascular disease;

  • Active liver disease (alanine aminotransferase or aspartate aminotransferase > 2times the upper limit of the normal range and)

  • Kidney dialysis or kidney transplantation or serum creatinine> 1.5 times the upperlimit of the normal range or CrCl <30 mL/min;

  • Previous or current diagnosis of heart failure;

  • Malignancy;

  • Any significant laboratory abnormalities such as serum potassium > 5.5 mmol/L.

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Sacubitril-Valsartan
Phase: 2
Study Start date:
November 11, 2020
Estimated Completion Date:
August 17, 2022

Study Description

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.

Connect with a study center

  • General Hospital Roberto Santos

    Salvador, Bahia 40301-110
    Brazil

    Site Not Available

  • Hospital Universitário Professor Edgard Santos

    Salvador, Bahia 40301-155
    Brazil

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.