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

NCT ID: NCT06169241

Last Updated: 2025-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-12-31

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.

Detailed Description

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Conditions

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Arterial Hypertension Resistant Hypertension Microvascular Function Nitrate Supplementation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Treatment with beetroot extract powder - nutritional supplementation
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Beetroot extract

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

Group Type ACTIVE_COMPARATOR

Beetroot extract

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Beetroot extract

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Cardiology, Laranjeiras, Brazil

OTHER_GOV

Sponsor Role lead

Responsible Party

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Eduardo Tibirica, MD, PhD

Senior Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Institute of Cardiology

Rio de Janeiro, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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EDUARDO TIBIRICA, MD, PhD

Role: CONTACT

+55-21-99914-6075

Facility Contacts

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Eduardo Tibirica

Role: primary

2125921265

Other Identifiers

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70847523.9.0000.5272

Identifier Type: -

Identifier Source: org_study_id

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