Sacubitril/Valsartan in Resistant Hypertension

NCT04637152 | Completed Phase 2 DMC

• 1 other identifier: HGeralRobertoSantos
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Resistant Hypertension; Blood Pressure

Keywords

Resistant Hypertension; LCZ696; Blood pressure control; sacubitril/valsartan

Outcome Measures

Primary Outcomes (2)

• 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

  8 weeks

• Secondary efficacy outcomes included BP reduction stratified by Sac-Val dose compared to standard therapy.

  Secondary outcome

  8 weeks

Secondary Outcomes (1)

• Secondary safety outcomes included incidence of acute myocardial infarction, hospitalization, stroke, hypotension, angioedema, electrolyte disturbances, CKD progression, and CV mortality

  8 weeks

Study Arms (2)

Group A: Usual recommended therapy

NO INTERVENTION

Antihypertensive regimen based on the usual recommended (optimized) therapy.

Group B: Sacubitril/Valsartan

EXPERIMENTAL

Suspension of ACE inhibitors - for at least 36h of the last dose - or ARB. Initial dosage: Sacubitril/valsartan 49mg/51mg, 1 tablet twice daily. Target dose (after two weeks): 97mg/103 mg, 1 tablet twice daily.

Drug: Sacubitril-Valsartan

Interventions

Sacubitril-Valsartan DRUG

Use of sacubitril/valsartan after suspension of ACE inhibitors or ARBs.

Group B: Sacubitril/Valsartan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Geral Roberto Santos: lead
• Hospital Universitário Professor Edgard Santos: collaborator

Study Sites (2)

General Hospital Roberto Santos

Salvador, Estado de Bahia, 40301-110, Brazil

Location

Hospital Universitário Professor Edgard Santos

Salvador, Estado de Bahia, 40301-155, Brazil

Location

MeSH Terms

Interventions

sacubitril and valsartan sodium hydrate drug combination

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single (Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Model Details: It was adopted an equal allocation of patients to each treatment (i.e., 1:1 randomization)

Study Record Dates

• First Submitted: November 14, 2020
• First Posted: November 19, 2020
• Study Start: November 11, 2020
• Primary Completion: July 22, 2022
• Study Completion: August 17, 2022
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

BR (2)