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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06169241
Other study ID # 70847523.9.0000.5272
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
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
Health authority
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

Study Design


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
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