A new clinical trial of Anti-Hypertensive Effect of Sacubitril/Valsartan in Resistant Hypertension: Randomized Clinical Trial - The HEVA Study

The Hospital Geral Roberto Santos is enrolling patients into the clinical trial investigating Sacubitril/Valsartan in Resistant Hypertension (HEVA).

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.

The intervention/treatment is: use of sacubitril/valsartan after suspension of ACE inhibitors or ARBs.

The trial is designed to enroll male and female of 18 Years and older and is being conducted in the General Hospital Roberto Santos, Salvador, Bahia, Brazil; Hospital Universitário Professor Edgard Santos, Salvador, Bahia, Brazil.

The study start date is November 11, 2020.

The patients that can be enrolled into this study include:

  • Men or women, over 18, diagnosed with resistant hypertension, using three or more antihypertensive agents of different classes (angiotensin-converting enzyme inhibitor, angiotensin II receptor blocker, calcium channel blockers, loop and thiazide diuretics or potassium-sparing diuretics), at least 4 weeks before recruitment, with a BP that remains above the goal of 140/90 mmHg.

The population that are excluded from participation:

  • Secondary and treatable hypertension; history of angioedema; significant cerebrovascular disease; active liver disease, kidney dialysis or kidney transplantation; previous or current diagnosis of heart failure; malignancy; and any significant laboratory abnormalities such as serum potassium > 5.5 mmol/L, alanine aminotransferase or aspartate aminotransferase > 2 times the upper limit of the normal range and serum creatinine> 1.5 times the upper limit of the normal range.

This page provides a more detailed overview of this clinical trial: 

https://ichgcp.net/clinical-trials-registry/NCT04637152

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