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

National Institute of Cardiology, Laranjeiras, Brazil

Status and phase: Enrolling; Early Phase 1

Conditions: Microvascular Function; Resistant Hypertension; Arterial Hypertension; Nitrate Supplementation

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Beetroot extract

Study type: Interventional

Funder types: Other

Identifiers

NCT06169241

70847523.9.0000.5272

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

The placebo group will be administered as a colored and flavored isocaloric supplement composed of maltodextrin.

Treatment:

Dietary Supplement: Placebo

Beetroot extract

Active Comparator group

Description:

Beetroot extract powder supplementation with 400mg of nitrate per dose in the amount of 10g per day orally will be used in the group.

Treatment:

Dietary Supplement: Beetroot extract