Actively Recruiting

Early Phase 1
Age: 18Years - 75Years
All Genders
ID06169241

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

Led by National Institute of Cardiology, Laranjeiras, Brazil · Updated on 2026-04-13

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying resistant arterial hypertension, a serious condition where high blood pressure remains elevated despite treatment. This condition increases risks for heart disease, stroke, kidney failure, and death. The study aims to evaluate if nitrate supplementation from beetroot powder can improve blood pressure and microvascular function in these patients. Beetroot powder is being considered as a simpler way to boost nitric oxide, which helps widen blood vessels. Participants are randomly assigned to one of two groups: one receives beetroot extract powder containing 400mg of nitrate daily, taken as 10 grams orally, while the other group receives a placebo supplement made of maltodextrin that matches the beetroot powder in color and flavor. The study is designed with quadruple masking to keep participants and staff unaware of group assignments. The main treatment period lasts 60 days. During the trial, participants will have their blood pressure monitored regularly to assess changes over the 60-day period. Researchers will track how blood pressure evolves and may evaluate systemic microvascular function. The total duration of participation corresponds to the treatment period, with safety and adherence monitored throughout. This study is led by the National Institute of Cardiology in Brazil and aims to provide clearer evidence on nitrate supplementation's effects in resistant hypertension.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed resistant hypertension documented in medical records
  • No changes in hypertension medications or doses within the last 30 days
  • Age between 18 and 75 years
  • Both genders included
Not Eligible

You will not qualify if you...

  • Presence of any type of cancer (neoplasms)
  • Diagnosis of heart failure
  • Current use of medications containing nitrate
  • Patients who have undergone renal denervation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 60 days

Participants receive either beetroot extract or placebo supplementation orally daily to assess effects on blood pressure and microvascular function.

Daily supplementation with crossover design

Trial Site Locations

Total: 1 location

1

National Institute of Cardiology

Rio de Janeiro, Brazil, 21040-360

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Research Team

E

EDUARDO TIBIRICA, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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