Arterial HypertensionEarly Phase 1NCT06169241
Effect of Nitrate Supplementation on Blood Pressure and Microvascular Function of Resistant Hypertensive Patients
A Early Phase 1 study testing Beetroot extract in people with Arterial Hypertension and Resistant Hypertension, run by National Institute of Cardiology, Laranjeiras, Brazil at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arterial Hypertension, Resistant Hypertension, Microvascular Function
- What is being tested?
- Beetroot extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2023to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resistant hypertension, with a diagnosis described in the medical record, without changing medications or increasing doses in the last 30 days.
Who cannot join
- neoplasms
- heart failure
- use of medications with nitrate in their formula
- patients undergoing renal denervation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
National Institute of Cardiology
Rio de Janeiro, 21040-360
Eduardo Tibirica, 2125921265, eitib@uol.com.br
About this study
Official title: Effect of Nitrate Supplementation on Blood Pressure and Systemic 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.
- Conditions
- Arterial Hypertension, Resistant Hypertension, Microvascular Function, Nitrate Supplementation
- Being tested
- Beetroot extract, Placebo
- Keywords
- microcirculation, capillary density, microvascular reactivity, systemic resistant hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot extractDietary 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.
PlaceboDietary supplement
The placebo will be administered as a colored and flavored isocaloric supplement composed of maltodextrin.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The placebo group will be administered as a colored and flavored isocaloric supplement composed of maltodextrin. Receives: Dietary Supplement: Placebo |
| Beetroot extract | Active comparator | Beetroot extract powder supplementation with 400mg of nitrate per dose in the amount of 10g per day orally will be used in the group. Receives: Dietary Supplement: Beetroot extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of blood pressure evolution
Evaluation using Ambulatory Blood Pressure Monitoring: systolic, diastolic and mean arterial pressures
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start1 Nov 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Treatment with beetroot extract powder - nutritional supplementation
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Laranjeiras, Brazil
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169241
- Sponsor's protocol ID
- 70847523.9.0000.5272
- Status last verified
- Apr 2026
- First submitted
- 5 Dec 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nitrate Supplementation on Blood Pressure and Systemic Microvascular Function of Resistant Hypertensive Patients
- ClinicalTrials.gov ID
- NCT06169241
- Acronym / sponsor ID
- 70847523.9.0000.5272
- Conditions
- Arterial Hypertension, Resistant Hypertension, Microvascular Function, Nitrate Supplementation
- Keywords
- microcirculation, capillary density, microvascular reactivity, systemic resistant hypertension
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Institute of Cardiology, Laranjeiras, BrazilOther government
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Treatment with beetroot extract powder - nutritional supplementation
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe placebo group will be administered as a colored and flavored isocaloric supplement composed of maltodextrin. |
| Beetroot extract | Active comparator | Dietary Supplement: Beetroot extractBeetroot extract powder supplementation with 400mg of nitrate per dose in the amount of 10g per day orally will be used in the group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Resistant hypertension, with a diagnosis described in the medical record, without changing medications or increasing doses in the last 30 days.
Key exclusion criteria (4 listed)
- neoplasms
- heart failure
- use of medications with nitrate in their formula
- patients undergoing renal denervation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beetroot extractBeetroot extract powder supplementation with 400mg of nitrate per dose in the amount of 10g per day orally will be used in the group. | Dietary supplement | Beetroot extract |
| PlaceboThe placebo will be administered as a colored and flavored isocaloric supplement composed of maltodextrin. | Dietary supplement | Placebo |
Primary outcome
Assessment of blood pressure evolution
Time frame: 60 days
Evaluation using Ambulatory Blood Pressure Monitoring: systolic, diastolic and mean arterial pressures
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Arterial Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Beetroot extract in people with Arterial Hypertension and Resistant Hypertension, run by National Institute of Cardiology, Laranjeiras, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact EDUARDO TIBIRICA, MD, PhD (+55-21-99914-6075, etibi@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of blood pressure evolution (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.