Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Recruiting NCT05684055 - "Community-based, eHealth Supported Management of Cardiovascular Risk Factors by Lay Village Health Workers (ComBaCaL aHT TwiC 1 & ComBaCaL aHT TwiC 2) N/A
Active, not recruiting NCT05436730 - "Escape" Phenomenon of the Antihypertensive Therapy Efficacy
Not yet recruiting NCT03294070 - Fimasartan Plus Amlodipine on Hemodynamic Parameters and Arterial Stiffness in Patients With Hypertension Phase 4
Recruiting NCT01959997 - Comparison of Redo PVI With vs. Without Renal Denervation for Recurrent AF After Initial PVI Phase 2
Completed NCT00983632 - Selective Vagus Nerve Stimulation in Human N/A
Recruiting NCT06098300 - Effects of Change in Blood Pressure on Retinal Capillary Rarefaction in Patients With Arterial Hypertension
Completed NCT04564118 - A Retrospective Analysis of the Adherence to Clinical Practice Guidelines Using the "MedicBK" Digital Platform in Patients With Hypertension and Atrial Fibrillation
Terminated NCT04677322 - TO ASSESS THE EFFECTIVENESS OF THE INTERVENTION OF THE LOW-SODIUM DIET IN PATIENTS WITH HTA
Completed NCT04278001 - Clinical Usefullness of the Cuffless SOMNOtouch NIBP Device for 24-hour Ambulatory Blood Pressure Measurement N/A
Withdrawn NCT03047538 - Fixed Combination for Lipid and Blood Pressure Control Phase 4
Completed NCT03046264 - Invasive Validation of Non-invasive Central Blood Pressure Measurements Using Oscillometric Pulse Wave Analysis N/A
Completed NCT02620995 - Effects of Sildenafil on Penile Vascular Function in Hypertensive Men With Erectile Dysfunction Phase 4
Completed NCT02041832 - Detection of Subclinical Atrial Fibrillation in High Risk Patients Using Implantable Loop Recorder N/A
Completed NCT01459120 - Comparison of Door-to-door Versus Community Gathering to Provide HIV Counseling and Testing Services in Rural Lesotho N/A
Completed NCT01546181 - Retinal Imaging by Adaptive Optics in Healthy Eyes and During Retinal and General Diseases
Recruiting NCT01132001 - Ambulatory Versus Home Blood Pressure Measurement N/A
Completed NCT01454583 - Registry for Ambulant Therapy With RAS-Inhibitors in Hypertension-patients in Germany N/A
Recruiting NCT03917758 - Antidiuretic Function Before and During Treatment With SGLT2 Inhibitors N/A
Completed NCT03722524 - The Use of TrIple Fixed-dose Combination in the Treatment of Arterial Hypertension
Completed NCT03539627 - Azilsartan Medoxomil in Hypertensive pAtients With Stable Ischemic Heart Disease and DiabEtes MEllitus.