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

NCT06169241 | Recruiting Early Phase 1

• 1 other identifier: 70847523.9.0000.5272
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arterial Hypertension; Resistant Hypertension; Microvascular Function; Nitrate Supplementation

Keywords

microcirculation; capillary density; microvascular reactivity; systemic resistant hypertension

Outcome Measures

Primary Outcomes (1)

• Assessment of blood pressure evolution

  Evaluation using Ambulatory Blood Pressure Monitoring: systolic, diastolic and mean arterial pressures

  60 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Beetroot extract

ACTIVE COMPARATOR

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

Interventions

Beetroot extract 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.

Beetroot extract

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Resistant hypertension, with a diagnosis described in the medical record, without changing medications or increasing doses in the last 30 days.

You may not qualify if:

• neoplasms
• heart failure
• use of medications with nitrate in their formula
• patients undergoing renal denervation

Sponsors & Collaborators

• National Institute of Cardiology, Laranjeiras, Brazil: lead

Study Sites (1)

National Institute of Cardiology

Rio de Janeiro, 21040-360, Brazil

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

EDUARDO TIBIRICA, MD, PhD

CONTACT

+55-21-99914-6075; etibi@uol.com.br

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Model Details: Treatment with beetroot extract powder - nutritional supplementation

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)