HypertensionNCT04403347
Effect of Gut Microbiome Restoration on Primary Hypertension Via Dietary Intervention
A study testing Innovative Dietary Formulation (Patent ID: CN110250417A) and Regular Diet in people with Hypertension, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 8 sites in China.
Trial summary
Mounting preclinical and clinical evidences have proved the optimal role of diets (i.e. DASH (Dietary Approaches to Stop Hypertension) diet, Mediterranean diet) on BP control and a causal role of gut microbiota on the pathogenesis of primary hypertension. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Innovative Dietary Formulation (Patent ID: CN110250417A) and Regular Diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 8 sitesChina
- Study dates
- 8 Jul 2021to 12 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18~60 years.
- Established Diagnosis of Grade 1 Hypertension (initial diagnosis or free from antihypertensive drugs within a month): 140mmHg≤ Office SBP<160mmHg for three measurements at different days without any antihypertensive medications, according to the "2010 Chinese Guidelines for Prevention and Treatment of Hypertension".
- Patients with informed consent after thorough explanation.
Who cannot join
- Antibiotics or probiotics usage within last 4 weeks
- Participants of other clinical trials related to hypertension currently or within last 3 months
- Antihypertensive medications usage currently or within last month
- Diagnosed secondary hypertension
- Severe hepatic or renal diseases ((ALT >3 times the upper limit of normal value, or end stage renal disease on dialysis or eGFR <30 mL/min/1.73 m2, or serum creatinine >2.5 mg/dl [>221 μmol/L])
- History of large atherosclerotic cerebral infarction or hemorrhagic stroke (not including lacunar infarction and transient ischemic attack [TIA])
Show all 15Show fewer
- Hospitalization for myocardial infarction within last 6 months; Coronary revascularization (PCI or CABG) within last 12 months; Planned for PCI or CABG in the next 12 months.
- Sustained atrial fibrillation or arrhythmias at recruitment disturbing the electronic BP measurement.
- NYHA class III-IV heart failure; Hospitalization for chronic heart failure exacerbation within last 6 months.
- Severe valvular diseases; Potential for surgery or percutaneous valve replacement within the study period.
- Dilated cardiomyopathy; Hypertrophic cardiomyopathy; Rheumatic heart disease; Congenital heart disease.
- Other severe diseases influencing the entry or survival of participants, such as malignant tumor or acquired immune deficiency syndrome.
- Cognitive impairment or severe neuropsychiatric comorbidities who are incapable of providing their own informed consent.
- Participants preparing for or under pregnancy and/or lactation.
- Other conditions inappropriate for recruitment according to the investigators.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Beijing Pinggu Hospital
Beijing, Beijing Municipality
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing
Clinical Medical College&Affiliated Hospital of Chengdu University
Chengdu, Sichuan
First Affiliated Hospital of Chongqing Medical University
Chongqing
First Affiliated Hospital of Jinan University
Guangzhou, Guangdong
Second Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong
Longgang District People's Hospital of Shenzhen
Shenzhen, Guangdong
the People's Hospital of Ji Xian District
Tianjin
About this study
Official title: Effect of Tartary Buckwheat Diet Intervention on Primary Hypertension and the Underlying Mechanism of Gut Microbiome Restoration
Mounting preclinical and clinical evidences have proved the optimal role of diets (i.e. DASH (Dietary Approaches to Stop Hypertension) diet, Mediterranean diet) on BP control and a causal role of gut microbiota on the pathogenesis of primary hypertension. Dietary changes appeared to reshape gut microbiota and to ameliorate diseases such as Type 2 Diabetes. A hypothesis is thus raised that dietary changes can be a potential approach to ameliorate hypertension via gut microbiome restoration. This pilot study will utilize an innovative natural dietary formulation (patent ID: CN110250417A) derived from Tartary buckwheat(TBW) diet, in comparison with usual care (guideline-based patient education and lifestyle recommendations), to investigate its effect and safety on primary hypertension treatment, and the underlying mechanisms of gut microbiome restoration.
Read the detailed description
Primary hypertension is a most prevalent cardiovascular diseases, and becomes a severe global public health issue because of the high morbidity and potential risk to other cardiovascular diseases. Several animal studies and diverse patient cohorts reported that the disorder of gut microbiome correlated with hypertension. Based on the investigators' previous work findings of metagenomics analysis, fecal transplantation and metabolomics changes in hypertension and pre-hypertension patients, a casual role of gut microbiome disorder was observed in primary hypertension and raised a hypothesis that gut microbiome restoration can be a potential approach to ameliorate hypertension. Recent studies indicated FMT, prebiotics, probiotics, dietary changes and other methodologies can assist gut microbiome restoration in diseases such as type 2 diabetes. The investigators therefore develop two pilot studies respectively utilizing FMT capsules (Pilot Study I) and innovative dietary changes (Pilot Study II) to explore the methodologies, effect, safety and underlying mechanisms of gut microbiome restoration on hypertension. These pilot studies also present as the clinical translational part of the research project "The Role of Gut Microbiome in the Pathogenesis of Essential Hypertension"(Project ID 81630014, sponsored by National Natural Science Foundation of China).
This study is the Pilot Study II:
Objective: With reference of DASH diet and Mediterranean diet, this study aims to explore the effect and safety of an innovative natural dietary formulation (deriving from TBW diet) on primary hypertension, and the underlying mechanisms of gut microbiome restoration.
Study Design: A multicenter, randomized, open-label, controlled study.
Data quality control and statistical analysis: The investigators have invited professional statistic analysts to assist analyzing data and a third party to supervise data quality.
Ethics: The Ethics Committee of Fuwai Hospital approved this study. Informed consents before patient enrollment are required.
- Conditions
- Hypertension
- Being tested
- Innovative Dietary Formulation (Patent ID: CN110250417A), Regular Diet
- Keywords
- Hypertension, Microbiome, Treatment, Diet
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Innovative Dietary Formulation (Patent ID: CN110250417A)Dietary supplement
In addition to adherence to a regular diet and standard hypertension care, participants will receive an innovative dietary formulation incorporated into their daily meals and administered orally.
Regular DietOther
Regular Diet with Usual Care
| Study group | Role | What they receive |
|---|---|---|
| Innovative Dietary Formulation | Experimental | In addition to adherence to a regular diet and usual hypertension care, participants will receive an innovative dietary formulation (TBW diet) incorporated into their daily meals and administered orally. Receives: Dietary Supplement: Innovative Dietary Formulation (Patent ID: CN110250417A) |
| Usual Care | Other | Usual Care (Guideline-based patient education and lifestyle recommendations) Receives: Other: Regular Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change for Office Systolic Blood Pressure (SBP)
Change for Office Systolic Blood Pressure (SBP)
Measured: From Baseline to the Month 2 (Week 8) follow-up visit
Secondary outcomes (13)
Change for office SBP
Change for office SBP
Measured: Baseline, Month 1(Week 4), Month 3(Week 12)
Change for Office Diastolic Blood Pressure (DBP)
Change for Office Diastolic Blood Pressure (DBP)
Measured: Baseline, Month 1(Week 4), Month 2 (Week 8), Month 3 (Week 12)
Change for daytime average SBP via 24-hour Ambulatory BP Monitoring
Change for daytime average SBP via 24-hour Ambulatory BP Monitoring
Measured: Baseline, Month 1(Week 4), Month 2(Week 8), Month 3(Week 12)
Change for daytime average DBP via 24-hour Ambulatory BP Monitoring
Change for daytime average DBP via 24-hour Ambulatory BP Monitoring
Measured: Baseline, Month 1(Week 4), Month 2(Week 8), Month 3(Week 12)
Change for nighttime average SBP via 24-hour Ambulatory BP Monitoring
Change for nighttime average SBP via 24-hour Ambulatory BP Monitoring
Measured: Baseline, Month 1(Week 4), Month 2(Week 8), Month 3(Week 12)
Change for nighttime average DBP via 24-hour Ambulatory BP Monitoring
Change for nighttime average DBP via 24-hour Ambulatory BP Monitoring
Measured: Baseline, Month 1(Week 4), Month 2(Week 8), Month 3(Week 12)
Number of Participants with Adverse Events (AEs) as a Measure of Safety
Number of Participants with Adverse Events (AEs) as a Measure of Safety
Measured: All AEs over 3 months
Intestinal Microbiota Composition Pre- and Post-intervention (innovative dietary formulation or usual care) via Metagenomic Analysis
Intestinal Microbiota Composition Pre- and Post-intervention (innovative dietary formulation or usual care) via Metagenomic Analysis
Measured: Baseline, Month 1(Week 4), Month 2(Week 8), Month 3(Week 12)
Intestinal Microbiota function Pre- and Post-intervention (innovative dietary formulation or usual care) via Metagenomic Analysis
Intestinal Microbiota function Pre- and Post-intervention (innovative dietary formulation or usual care) via Metagenomic Analysis
Measured: Baseline, Month 1(Week 4), Month 2(Week 8), Month 3(Week 12)
Plasma Metabolite Composition Pre- and Post-intervention (innovative dietary formulation or usual care) via Metabolomic Analysis
Plasma Metabolite Composition Pre- and Post-intervention (innovative dietary formulation or usual care) via Metabolomic Analysis
Measured: Baseline, Month 1(Week 4), Month 2(Week 8), Month 3(Week 12)
Change for Fasting Blood Glucose Level
Change for Fasting Blood Glucose Level
Measured: Baseline, Month 2(Week 8)
Change for Blood Lipid Level (Total Cholesterol, Total Triglyceride, Low Density Lipoprotein Cholesterol, High Density Lipoprotein Cholesterol)
Change for Blood Lipid Level (Total Cholesterol, Total Triglyceride, Low Density Lipoprotein Cholesterol, High Density Lipoprotein Cholesterol)
Measured: Baseline, Month 2(Week 8)
Change for Body Mass Index
Change for Body Mass Index
Measured: Baseline, Month 2(Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start8 Jul 2021
- Primary completion14 Aug 2024
- Study completion12 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China, Beijing Anzhen Hospital
- Responsible party
- Principal investigator, Jun Cai, Beijing Anzhen Hospital
- Investigators
- Jun Cai, MD,PhD, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403347
- Sponsor's protocol ID
- 2017-GZ10 (Part II)
- Status last verified
- Jan 2026
- First submitted
- 20 May 2020
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li J, Zhao F, Wang Y, Chen J, Tao J, Tian G, Wu S, Liu W, Cui Q, Geng B, Zhang W, Weldon R, Auguste K, Yang L, Liu X, Chen L, Yang X, Zhu B, Cai J. Gut microbiota dysbiosis contributes to the development of hypertension. Microbiome. 2017 Feb 1;5(1):14. doi: 10.1186/s40168-016-0222-x.
PubMed 28143587Zhao L, Zhang F, Ding X, Wu G, Lam YY, Wang X, Fu H, Xue X, Lu C, Ma J, Yu L, Xu C, Ren Z, Xu Y, Xu S, Shen H, Zhu X, Shi Y, Shen Q, Dong W, Liu R, Ling Y, Zeng Y, Wang X, Zhang Q, Wang J, Wang L, Wu Y, Zeng B, Wei H, Zhang M, Peng Y, Zhang C. Gut bacteria selectively promoted by dietary fibers alleviate type 2 diabetes. Science. 2018 Mar 9;359(6380):1151-1156. doi: 10.1126/science.aao5774.
PubMed 29590046Marques FZ, Nelson E, Chu PY, Horlock D, Fiedler A, Ziemann M, Tan JK, Kuruppu S, Rajapakse NW, El-Osta A, Mackay CR, Kaye DM. High-Fiber Diet and Acetate Supplementation Change the Gut Microbiota and Prevent the Development of Hypertension and Heart Failure in Hypertensive Mice. Circulation. 2017 Mar 7;135(10):964-977. doi: 10.1161/CIRCULATIONAHA.116.024545. Epub 2016 Dec 7.
PubMed 27927713
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tartary Buckwheat Diet Intervention on Primary Hypertension and the Underlying Mechanism of Gut Microbiome Restoration
- ClinicalTrials.gov ID
- NCT04403347
- Acronym / sponsor ID
- 2017-GZ10 (Part II)
- Conditions
- Hypertension
- Keywords
- Hypertension, Microbiome, Treatment, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China, Beijing Anzhen Hospital
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 14 Aug 2024 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 27 May 2020 (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.
Mounting preclinical and clinical evidences have proved the optimal role of diets (i.e. DASH (Dietary Approaches to Stop Hypertension) diet, Mediterranean diet) on BP control and a causal role of gut microbiota on the pathogenesis of primary hypertension. Dietary changes appeared to reshape gut microbiota and to ameliorate diseases such as Type 2 Diabetes. A hypothesis is thus raised that dietary changes can be a potential approach to ameliorate hypertension via gut microbiome restoration. This pilot study will utilize an innovative natural dietary formulation (patent ID: CN110250417A) derived from Tartary buckwheat(TBW) diet, in comparison with usual care (guideline-based patient education and lifestyle recommendations), to investigate its effect and safety on primary hypertension treatment, and the underlying mechanisms of gut microbiome restoration.
Detailed description
Primary hypertension is a most prevalent cardiovascular diseases, and becomes a severe global public health issue because of the high morbidity and potential risk to other cardiovascular diseases. Several animal studies and diverse patient cohorts reported that the disorder of gut microbiome correlated with hypertension. Based on the investigators' previous work findings of metagenomics analysis, fecal transplantation and metabolomics changes in hypertension and pre-hypertension patients, a casual role of gut microbiome disorder was observed in primary hypertension and raised a hypothesis that gut microbiome restoration can be a potential approach to ameliorate hypertension. Recent studies indicated FMT, prebiotics, probiotics, dietary changes and other methodologies can assist gut microbiome restoration in diseases such as type 2 diabetes. The investigators therefore develop two pilot studies respectively utilizing FMT capsules (Pilot Study I) and innovative dietary changes (Pilot Study II) to explore the methodologies, effect, safety and underlying mechanisms of gut microbiome restoration on hypertension. These pilot studies also present as the clinical translational part of the research project "The Role of Gut Microbiome in the Pathogenesis of Essential Hypertension"(Project ID 81630014, sponsored by National Natural Science Foundation of China).
This study is the Pilot Study II:
Objective: With reference of DASH diet and Mediterranean diet, this study aims to explore the effect and safety of an innovative natural dietary formulation (deriving from TBW diet) on primary hypertension, and the underlying mechanisms of gut microbiome restoration.
Study Design: A multicenter, randomized, open-label, controlled study.
Data quality control and statistical analysis: The investigators have invited professional statistic analysts to assist analyzing data and a third party to supervise data quality.
Ethics: The Ethics Committee of Fuwai Hospital approved this study. Informed consents before patient enrollment are required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Innovative Dietary Formulation | Experimental | Dietary Supplement: Innovative Dietary Formulation (Patent ID: CN110250417A)In addition to adherence to a regular diet and usual hypertension care, participants will receive an innovative dietary formulation (TBW diet) incorporated into their daily meals and administered orally. |
| Usual Care | Other | Other: Regular DietUsual Care (Guideline-based patient education and lifestyle recommendations) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18~60 years.
- Established Diagnosis of Grade 1 Hypertension (initial diagnosis or free from antihypertensive drugs within a month): 140mmHg≤ Office SBP<160mmHg for three measurements at different days without any antihypertensive medications, according to the "2010 Chinese Guidelines for Prevention and Treatment of Hypertension".
- Patients with informed consent after thorough explanation.
Key exclusion criteria (15 listed)
- Antibiotics or probiotics usage within last 4 weeks
- Participants of other clinical trials related to hypertension currently or within last 3 months
- Antihypertensive medications usage currently or within last month
- Diagnosed secondary hypertension
- Severe hepatic or renal diseases ((ALT >3 times the upper limit of normal value, or end stage renal disease on dialysis or eGFR <30 mL/min/1.73 m2, or serum creatinine >2.5 mg/dl [>221 μmol/L])
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 |
|---|---|---|
| Innovative Dietary Formulation (Patent ID: CN110250417A)In addition to adherence to a regular diet and standard hypertension care, participants will receive an innovative dietary formulation incorporated into their daily meals and administered orally. | Dietary supplement | Innovative Dietary Formulation |
| Regular DietRegular Diet with Usual Care | Other | Usual Care |
Primary outcome
Change for Office Systolic Blood Pressure (SBP)
Time frame: From Baseline to the Month 2 (Week 8) follow-up visit
Change for Office Systolic Blood Pressure (SBP)
13 secondary outcomes
Change for office SBP
Time frame: Baseline, Month 1(Week 4), Month 3(Week 12)
Change for Office Diastolic Blood Pressure (DBP)
Time frame: Baseline, Month 1(Week 4), Month 2 (Week 8), Month 3 (Week 12)
Change for daytime average SBP via 24-hour Ambulatory BP Monitoring
Time frame: Baseline, Month 1(Week 4), Month 2(Week 8), Month 3(Week 12)
Change for daytime average DBP via 24-hour Ambulatory BP Monitoring
Time frame: Baseline, Month 1(Week 4), Month 2(Week 8), Month 3(Week 12)
Change for nighttime average SBP via 24-hour Ambulatory BP Monitoring
Time frame: Baseline, Month 1(Week 4), Month 2(Week 8), Month 3(Week 12)
Change for nighttime average DBP via 24-hour Ambulatory BP Monitoring
Time frame: Baseline, Month 1(Week 4), Month 2(Week 8), Month 3(Week 12)
Number of Participants with Adverse Events (AEs) as a Measure of Safety
Time frame: All AEs over 3 months
Intestinal Microbiota Composition Pre- and Post-intervention (innovative dietary formulation or usual care) via Metagenomic Analysis
Time frame: Baseline, Month 1(Week 4), Month 2(Week 8), Month 3(Week 12)
Intestinal Microbiota function Pre- and Post-intervention (innovative dietary formulation or usual care) via Metagenomic Analysis
Time frame: Baseline, Month 1(Week 4), Month 2(Week 8), Month 3(Week 12)
Plasma Metabolite Composition Pre- and Post-intervention (innovative dietary formulation or usual care) via Metabolomic Analysis
Time frame: Baseline, Month 1(Week 4), Month 2(Week 8), Month 3(Week 12)
Change for Fasting Blood Glucose Level
Time frame: Baseline, Month 2(Week 8)
Change for Blood Lipid Level (Total Cholesterol, Total Triglyceride, Low Density Lipoprotein Cholesterol, High Density Lipoprotein Cholesterol)
Time frame: Baseline, Month 2(Week 8)
Change for Body Mass Index
Time frame: Baseline, Month 2(Week 8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Background: PubMed 28143587Li J, Zhao F, Wang Y, Chen J, Tao J, Tian G, Wu S, Liu W, Cui Q, Geng B, Zhang W, Weldon R, Auguste K, Yang L, Liu X, Chen L, Yang X, Zhu B, Cai J. Gut microbiota dysbiosis contributes to the development of hypertension. Microbiome. 2017 Feb 1;5(1):14. doi: 10.1186/s40168-016-0222-x.
- Background: PubMed 29590046Zhao L, Zhang F, Ding X, Wu G, Lam YY, Wang X, Fu H, Xue X, Lu C, Ma J, Yu L, Xu C, Ren Z, Xu Y, Xu S, Shen H, Zhu X, Shi Y, Shen Q, Dong W, Liu R, Ling Y, Zeng Y, Wang X, Zhang Q, Wang J, Wang L, Wu Y, Zeng B, Wei H, Zhang M, Peng Y, Zhang C. Gut bacteria selectively promoted by dietary fibers alleviate type 2 diabetes. Science. 2018 Mar 9;359(6380):1151-1156. doi: 10.1126/science.aao5774.
- Background: PubMed 27927713Marques FZ, Nelson E, Chu PY, Horlock D, Fiedler A, Ziemann M, Tan JK, Kuruppu S, Rajapakse NW, El-Osta A, Mackay CR, Kaye DM. High-Fiber Diet and Acetate Supplementation Change the Gut Microbiota and Prevent the Development of Hypertension and Heart Failure in Hypertensive Mice. Circulation. 2017 Mar 7;135(10):964-977. doi: 10.1161/CIRCULATIONAHA.116.024545. Epub 2016 Dec 7.
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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. This study is not recruiting at the moment.
Jun Cai, MD,PhD principal investigator
Beijing Anzhen Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Innovative Dietary Formulation (Patent ID: CN110250417A) and Regular Diet in people with Hypertension, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 8 sites in China.
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 3 inclusion and 15 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: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change for Office Systolic Blood Pressure (SBP) (time frame: From Baseline to the Month 2 (Week 8) follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04403347, which also lists 3 linked publications.
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 14 Jan 2026.