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Sacubitril/Valsartan in Resistant Hypertension (HEVA)
NCT04637152Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2020
- Primary completion
- Jul 2022
- Countries
- 1
- Sponsor
- Hospital Geral Roberto Santos
- Modality
- Small Molecules
- Conditions
- resistant hypertension (RH)
01
Overview
Phase 2, randomised, open-label trial of sacubitril + valsartan in resistant hypertension (RH) (2 arms), sponsored by Hospital Geral Roberto Santos. Primary endpoints: Proportion of patients achieving blood pressure target <140/90 mmHg at 8 weeks, Reduction in mean sitting systolic blood pressure at 8 weeks and 2 more. Started Nov 2020; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Usual recommended therapy
Optimized antihypertensive therapy (ACEi/ARB + others).
Sacubitril/Valsartan
Sacubitril/Valsartan 49/51mg bid titrated to 97/103mg bid.
03
Who it enrols
Adult patients with resistant hypertension on 3+ agents including ACEi/ARB, CCB, and diuretic. Excludes patients with heart failure, severe renal dysfunction (CrCl <30), or active liver disease.
04
Endpoints
Primary
Proportion of patients achieving blood pressure target <140/90 mmHg
Reduction in mean sitting systolic blood pressure
Reduction in mean sitting diastolic blood pressure
Reduction in mean sitting pulse pressure
Secondary
Blood pressure reduction stratified by Sacubitril/Valsartan dose
Incidence of adverse events
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