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NCT Number: NCT06169241

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

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.

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Key information

Conditions

Arterial Hypertension Cardiovascular Diseases Hypertension Microvascular Function Nitrate Supplementation Resistant Hypertension Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

National Institute of Cardiology

Rio de Janeiro, 21040-360, Brazil

Location status: Recruiting

Location contact

Eduardo Tibirica

CONTACT

[email protected]

2125921265

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Placebo

Dietary Supplement

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

Primary outcomes

  1. Assessment of blood pressure evolution

    Time frame: 60 days

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

Study contacts

Contact information is provided by the study sponsor or research team.

EDUARDO TIBIRICA, MD, PhD

CONTACT

[email protected]

+55-21-99914-6075

Sponsors and collaborators

Lead sponsor

National Institute of Cardiology, Laranjeiras, Brazil

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 13, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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