Blood Pressure Clinical Trial
— HEVAOfficial title:
Anti-Hypertensive Effect of Sacubitril/Valsartan in Resistant Hypertension: Randomized Clinical Trial - The HEVA Study
Verified date | November 2020 |
Source | Hospital Geral Roberto Santos |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Brazil | General Hospital Roberto Santos | Salvador | Bahia |
Brazil | Hospital Universitário Professor Edgard Santos | Salvador | Bahia |
Lead Sponsor | Collaborator |
---|---|
Hospital Geral Roberto Santos | Hospital Universitário Professor Edgard Santos |
Brazil,
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 |
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