Sacubitril/Valsartan in Resistant Hypertension

• Status: Recruiting
• Trial end date: 2022-11-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Geral Roberto Santos
• Collaborator: Hospital Universitário Professor Edgard Santos
• Treatments: LCZ 696; Sacubitril and valsartan sodium hydrate drug combination; Valsartan

Criteria

Inclusion Criteria:

• Men or women, over 18;

• Diagnosed with resistant hypertension (using three or more antihypertensive agents of different classes - eg. 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.

Exclusion Criteria:

• Secondary and treatable hypertension;

• History of angioedema; significant cerebrovascular disease;

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

• Kidney dialysis or kidney transplantation or serum creatinine> 1.5 times the upper limit 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.