Effect of Nitrate Supplementation on Blood Pressure and Microvascular Function of Resistant Hypertensive Patients

Study Overview
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Brief Summary
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Arterial hypertension (AH) has been identified as an important public health problem and considered a new epidemic with high mortality and morbidity. High blood pressure (BP) levels increase the chances of coronary artery disease (CAD), heart failure (HF), stroke, chronic renal failure (CRF) and death. Beetroot powder may be an easier way to increase the availability of nitric oxide and consequently vasodilation in these patients. However, studies are needed to evaluate its benefits in patients with AH.

Official Title
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Effect of Nitrate Supplementation on Blood Pressure and Systemic Microvascular Function of Resistant Hypertensive Patients

Conditions
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Arterial Hypertension, Resistant Hypertension, Microvascular Function, Nitrate Supplementation

Intervention / Treatment
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* Dietary Supplement: Beetroot extract
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Resistant hypertension, with a diagnosis described in the medical record, without changing medications or increasing doses in the last 30 days. Exclusion Criteria: neoplasms heart failure use of medications with nitrate in their formula patients undergoing renal denervation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Treatment with beetroot extract powder - nutritional supplementation
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>The placebo group will be administered as a colored and flavored isocaloric supplement composed of maltodextrin. | Dietary Supplement: Placebo<br>* The placebo will be administered as a colored and flavored isocaloric supplement composed of maltodextrin.<br>|
| Active Comparator: Beetroot extract<br>Beetroot extract powder supplementation with 400mg of nitrate per dose in the amount of 10g per day orally will be used in the group. | Dietary Supplement: Beetroot extract<br>* Beetroot extract powder supplementation with 400mg of nitrate per dose in the amount of 10g per day orally will be used in the group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of blood pressure evolution | Evaluation using Ambulatory Blood Pressure Monitoring: systolic, diastolic and mean arterial pressures | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microcirculation, capillary density, microvascular reactivity, systemic resistant hypertension