Sacubitril/Valsartan in Resistant Hypertension

Blood Pressure Clinical Trial

— HEVA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04637152
• Other study ID #: HGeralRobertoSantos
• Status: Recruiting
• Phase: Phase 2
• Start date: November 11, 2020
• Est. completion date: November 11, 2022

Study information

• Verified date: November 2020
• Source: Hospital Geral Roberto Santos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 11, 2022
• Est. primary completion date: October 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension
• Resistant Hypertension

Intervention

Drug:
• Sacubitril-Valsartan
Use of sacubitril/valsartan after suspension of ACE inhibitors or ARBs.

Locations

Country	Name	City	State
Brazil	General Hospital Roberto Santos	Salvador	Bahia
Brazil	Hospital Universitário Professor Edgard Santos	Salvador	Bahia

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Geral Roberto Santos	Hospital Universitário Professor Edgard Santos

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in systolic blood pressure and diastolic blood pressure in the sitting position.	The mean reduction in systolic blood pressure and diastolic blood pressure in the sitting position	12 weeks
Primary	Mean reduction in ambulatory systolic blood pressure (maSBP) and ambulatory diastolic blood pressure	The mean reduction in ambulatory systolic blood pressure (maSBP) and ambulatory diastolic blood pressure (maDBP)	12 weeks
Secondary	Safety outcomes	Rate of hypotension, angioedema, uncontrolled blood pressure above 220x120, relevant hydroelectrolytic disorders, hospitalization, stroke and other cardiovascular events.	12 weeks