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

Arterial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06169241
• Other study ID #: 70847523.9.0000.5272
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 1, 2023
• Est. completion date: June 2025

Study information

• Verified date: December 2023
• Source: National Institute of Cardiology, Laranjeiras, Brazil
• Contact: EDUARDO TIBIRICA, MD, PhD
• Phone: +55-21-99914-6075
• Email: etibi[@]uol.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arterial Hypertension
• Hypertension
• Microvascular Function
• Resistant Hypertension

Intervention

Dietary Supplement:
• 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.
• Placebo
The placebo will be administered as a colored and flavored isocaloric supplement composed of maltodextrin.

Locations

Country	Name	City	State
Brazil	National Institute of Cardiology	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cardiology, Laranjeiras, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of blood pressure evolution	Evaluation using Ambulatory Blood Pressure Monitoring: systolic, diastolic and mean arterial pressures	60 days