HypertensionPhase 1NCT05608447
Effect of Intensive FMT on Primary Hypertension
A Phase 1 study testing FMT capsules in people with Hypertension, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 3 sites in China.
Trial summary
Mounting preclinical and clinical evidences have proved the causal role of gut microbiota on the pathogenesis of primary hypertension. Restoration of gut microbiota ameliorated high BP in rodents and/or human cases.A hypothesis is thus raised that gut microbiome restoration can be a potential approach to ameliorate… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- FMT capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jan 2023to 30 Sep 2023
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18~65 years.
- Established Diagnosis of Grade 1 Hypertension (initial diagnosis or free from antihypertensive drugs within a month): 140mmHg≤ Office SBP<160mmHg and/or 90mmHg≤ Office DBP<100mmHg 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
3 sites in 1 country.
China3 sites
The Second Affiliated Hospital of Shantou University
Shantou, Guangdong
Youren Chen
Shanxi Bethune Hospital
Taiyuan, Shanxi
Jie Ren
The People's Hospital of Ji Xian District
Tianjin, Tianjin Municipality
Jinfeng Yang
About this study
Official title: Effect and Safety of Intensive Fecal Microbiota Transplantation on Primary Hypertension: a Randomized Clinical Trial.
Mounting preclinical and clinical evidences have proved the causal role of gut microbiota on the pathogenesis of primary hypertension. Restoration of gut microbiota ameliorated high BP in rodents and/or human cases.A hypothesis is thus raised that gut microbiome restoration can be a potential approach to ameliorate hypertension. This study will perform intense fecal microbiota transplantation (FMT) intervention via oral capsules, in comparison with placebo capsules, to investigate the effect, safety and underlying mechanisms of gut microbiome intervention on primary hypertension.
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, a casual role of gut microbiome disorder was observed in primary hypertension (Microbiome. 2017;5(1):14.), and trend of ameliorating SBP was observed after short-course FMT intervention but recovery after intervention termination(Trials. 2022;23(1):178, unpublished results). The investigators therefore developed a consecutive study of intensive FMT intervention on primary hypertension.
Objective: To explore the effect, safety and underlying mechanisms of intensive FMT on primary hypertension.
Study Design: A multi-center, randomized, blinded, placebo-controlled pilot 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.
- Conditions
- Hypertension
- Being tested
- FMT capsules, Placebo capsules
- Keywords
- hypertension, microbiome, fecal microbiota transplantation, treatment
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMT capsulesBiological
FMT capsules containing extensively screened donor stool.
Placebo capsulesOther
Placebo capsules that do not contain donor stool or any active drug.
| Study group | Role | What they receive |
|---|---|---|
| FMT capsules | Active comparator | FMT capsules containing extensively screened donor stool. FMT capsules will be orally taken on Day 0 (randomization), Day 1, Day 2, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49. Receives: Biological: FMT capsules |
| Placebo capsules | Placebo comparator | Placebo capsules that do not contain donor stool or any active drug. Placebo capsules will be orally taken on Day 0 (randomization), Day 1, Day 2, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49. Receives: Other: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Office Systolic Blood Pressure (SBP)
Change in Office Systolic Blood Pressure (SBP)
Measured: From baseline to Week 8
Secondary outcomes (19)
Change in Office Systolic Blood Pressure (SBP)
Change in Office Systolic Blood Pressure (SBP)
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 12
Change in Office Diastolic Blood Pressure (DBP)
Change in Office Diastolic Blood Pressure (DBP)
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12
Change in Home Systolic Blood Pressure (SBP)
Change in Home Systolic Blood Pressure (SBP)
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12
Change in Home Diastolic Blood Pressure (DBP)
Change in Home Diastolic Blood Pressure (DBP), compared with baseline
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12
Change in average SBP via 24-hour Ambulatory BP Monitoring
Change in average SBP via 24-hour Ambulatory BP Monitoring
Measured: Baseline, Week 4, Week 8, Week 12
Change in average DBP via 24-hour Ambulatory BP Monitoring
Change in average DBP via 24-hour Ambulatory BP Monitoring
Measured: Baseline, Week 4, Week 8, Week 12
Change in daytime SBP via 24-hour Ambulatory BP Monitoring
Change in daytime SBP via 24-hour Ambulatory BP Monitoring
Measured: Baseline, Week 4, Week 8, Week 12
Change in daytime DBP via 24-hour Ambulatory BP Monitoring
Change in daytime DBP via 24-hour Ambulatory BP Monitoring
Measured: Baseline, Week 4, Week 8, Week 12
Change in nighttime SBP via 24-hour Ambulatory BP Monitoring
Change in nighttime SBP via 24-hour Ambulatory BP Monitoring
Measured: Baseline, Week 4, Week 8, Week 12
Change in nighttime DBP via 24-hour Ambulatory BP Monitoring
Change in nighttime DBP via 24-hour Ambulatory BP Monitoring
Measured: Baseline, Week 4, Week 8, 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 12 weeks
Changes in Intestinal Microbiota Composition Pre- and Post-intervention via Metagenomic Analysis
Changes in Intestinal Microbiota Composition Pre- and Post-intervention (FMT or Placebo) via Metagenomic Analysis, stratified by:
- Randomisation
- Change in Office SBP
Measured: Baseline, Week 4, Week 8, Week 12
Changes in Intestinal Microbiota function revealed by KEGG pathways and KEGG Orthology (KO) Pre- and Post-intervention via Metagenomic Analysis
Changes in Intestinal Microbiota function revealed by KEGG pathways and KEGG Orthology (KO) Pre- and Post-intervention via Metagenomic Analysis, stratified by:
- Randomisation
- Change in Office SBP
Measured: Baseline, Week 4, Week 8, Week 12
Durability of Engraftment of Donor Microbiome Following FMT
Durability of engraftment of donor microbiome following FMT, measured by similarity comparison of intestinal microbiota composition between donor and recipient
Measured: Baseline, Week 4, Week 8, Week 12
Changes in Plasma Metabolite Composition Pre- and Post-intervention via Metabolomic Analysis
Changes in Plasma Metabolite Composition Pre- and Post-intervention (FMT or Placebo) via Metabolomic Analysis, stratified by:
- Randomisation
- Change in Office SBP
Measured: Baseline, Week 4, Week 8, Week 12
Change in Fasting Blood Glucose Level
Change in Fasting Blood Glucose Level
Measured: Baseline, Week 4, Week 8, Week 12
Change in blood HbA1c level
Change in blood glycosylated hemoglobin, type A1C (HbA1c) level
Measured: Baseline, Week 4, Week 8, Week 12
Change in blood lipid level
Change in Blood Lipid Level (Total Cholesterol, Total Triglyceride, Low Density Lipoprotein Cholesterol, High Density Lipoprotein Cholesterol)
Measured: Baseline, Week 4, Week 8, Week 12
Change in Body Mass Index
Change in Body Mass Index
Measured: Baseline, Week 4, Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Cai, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Jun Cai, MD,PhD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608447
- Sponsor's protocol ID
- 2017-GZ10 (Part III)
- Status last verified
- Nov 2022
- First submitted
- 1 Nov 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The collected data, study protocol, and SAP are planned to be shared after the study ends 2 years later (anticipated)
Publications
Cammarota G, Ianiro G, Tilg H, Rajilic-Stojanovic M, Kump P, Satokari R, Sokol H, Arkkila P, Pintus C, Hart A, Segal J, Aloi M, Masucci L, Molinaro A, Scaldaferri F, Gasbarrini G, Lopez-Sanroman A, Link A, de Groot P, de Vos WM, Hogenauer C, Malfertheiner P, Mattila E, Milosavljevic T, Nieuwdorp M, Sanguinetti M, Simren M, Gasbarrini A; European FMT Working Group. European consensus conference on faecal microbiota transplantation in clinical practice. Gut. 2017 Apr;66(4):569-580. doi: 10.1136/gutjnl-2016-313017. Epub 2017 Jan 13.
PubMed 28087657Li 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 28143587Fan L, Ren J, Chen Y, Wang Y, Guo Z, Bu P, Yang J, Ma W, Zhu B, Zhao Y, Cai J. Effect of fecal microbiota transplantation on primary hypertension and the underlying mechanism of gut microbiome restoration: protocol of a randomized, blinded, placebo-controlled study. Trials. 2022 Feb 24;23(1):178. doi: 10.1186/s13063-022-06086-2.
PubMed 35209934
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Safety of Intensive Fecal Microbiota Transplantation on Primary Hypertension: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05608447
- Acronym / sponsor ID
- 2017-GZ10 (Part III)
- Conditions
- Hypertension
- Keywords
- hypertension, microbiome, fecal microbiota transplantation, treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 8 Nov 2022 (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 causal role of gut microbiota on the pathogenesis of primary hypertension. Restoration of gut microbiota ameliorated high BP in rodents and/or human cases.A hypothesis is thus raised that gut microbiome restoration can be a potential approach to ameliorate hypertension. This study will perform intense fecal microbiota transplantation (FMT) intervention via oral capsules, in comparison with placebo capsules, to investigate the effect, safety and underlying mechanisms of gut microbiome intervention on primary hypertension.
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, a casual role of gut microbiome disorder was observed in primary hypertension (Microbiome. 2017;5(1):14.), and trend of ameliorating SBP was observed after short-course FMT intervention but recovery after intervention termination(Trials. 2022;23(1):178, unpublished results). The investigators therefore developed a consecutive study of intensive FMT intervention on primary hypertension.
Objective: To explore the effect, safety and underlying mechanisms of intensive FMT on primary hypertension.
Study Design: A multi-center, randomized, blinded, placebo-controlled pilot 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMT capsules | Active comparator | Biological: FMT capsulesFMT capsules containing extensively screened donor stool. FMT capsules will be orally taken on Day 0 (randomization), Day 1, Day 2, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49. |
| Placebo capsules | Placebo comparator | Other: Placebo capsulesPlacebo capsules that do not contain donor stool or any active drug. Placebo capsules will be orally taken on Day 0 (randomization), Day 1, Day 2, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18~65 years.
- Established Diagnosis of Grade 1 Hypertension (initial diagnosis or free from antihypertensive drugs within a month): 140mmHg≤ Office SBP<160mmHg and/or 90mmHg≤ Office DBP<100mmHg 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 |
|---|---|---|
| FMT capsulesFMT capsules containing extensively screened donor stool. | Biological | FMT capsules |
| Placebo capsulesPlacebo capsules that do not contain donor stool or any active drug. | Other | Placebo capsules |
Primary outcome
Change in Office Systolic Blood Pressure (SBP)
Time frame: From baseline to Week 8
Change in Office Systolic Blood Pressure (SBP)
19 secondary outcomes
Change in Office Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 12
Change in Office Diastolic Blood Pressure (DBP)
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12
Change in Home Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12
Change in Home Diastolic Blood Pressure (DBP)
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12
Change in average SBP via 24-hour Ambulatory BP Monitoring
Time frame: Baseline, Week 4, Week 8, Week 12
Change in average DBP via 24-hour Ambulatory BP Monitoring
Time frame: Baseline, Week 4, Week 8, Week 12
Change in daytime SBP via 24-hour Ambulatory BP Monitoring
Time frame: Baseline, Week 4, Week 8, Week 12
Change in daytime DBP via 24-hour Ambulatory BP Monitoring
Time frame: Baseline, Week 4, Week 8, Week 12
Change in nighttime SBP via 24-hour Ambulatory BP Monitoring
Time frame: Baseline, Week 4, Week 8, Week 12
Change in nighttime DBP via 24-hour Ambulatory BP Monitoring
Time frame: Baseline, Week 4, Week 8, Week 12
Number of Participants with Adverse Events (AEs) as a Measure of Safety
Time frame: All AEs over 12 weeks
Changes in Intestinal Microbiota Composition Pre- and Post-intervention via Metagenomic Analysis
Time frame: Baseline, Week 4, Week 8, Week 12
Changes in Intestinal Microbiota function revealed by KEGG pathways and KEGG Orthology (KO) Pre- and Post-intervention via Metagenomic Analysis
Time frame: Baseline, Week 4, Week 8, Week 12
Durability of Engraftment of Donor Microbiome Following FMT
Time frame: Baseline, Week 4, Week 8, Week 12
Changes in Plasma Metabolite Composition Pre- and Post-intervention via Metabolomic Analysis
Time frame: Baseline, Week 4, Week 8, Week 12
Change in Fasting Blood Glucose Level
Time frame: Baseline, Week 4, Week 8, Week 12
Change in blood HbA1c level
Time frame: Baseline, Week 4, Week 8, Week 12
Change in blood lipid level
Time frame: Baseline, Week 4, Week 8, Week 12
Change in Body Mass Index
Time frame: Baseline, Week 4, Week 8, Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Background: PubMed 28087657Cammarota G, Ianiro G, Tilg H, Rajilic-Stojanovic M, Kump P, Satokari R, Sokol H, Arkkila P, Pintus C, Hart A, Segal J, Aloi M, Masucci L, Molinaro A, Scaldaferri F, Gasbarrini G, Lopez-Sanroman A, Link A, de Groot P, de Vos WM, Hogenauer C, Malfertheiner P, Mattila E, Milosavljevic T, Nieuwdorp M, Sanguinetti M, Simren M, Gasbarrini A; European FMT Working Group. European consensus conference on faecal microbiota transplantation in clinical practice. Gut. 2017 Apr;66(4):569-580. doi: 10.1136/gutjnl-2016-313017. Epub 2017 Jan 13.
- Results publication: 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.
- Results publication: PubMed 35209934Fan L, Ren J, Chen Y, Wang Y, Guo Z, Bu P, Yang J, Ma W, Zhu B, Zhao Y, Cai J. Effect of fecal microbiota transplantation on primary hypertension and the underlying mechanism of gut microbiome restoration: protocol of a randomized, blinded, placebo-controlled study. Trials. 2022 Feb 24;23(1):178. doi: 10.1186/s13063-022-06086-2.
- Individual participant dataSharing planned: Yes. The collected data, study protocol, and SAP are planned to be shared after the study ends 2 years later (anticipated)
Related trials for 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. This study is not recruiting at the moment.
Jun Cai, MD,PhD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FMT capsules in people with Hypertension, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 3 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: status not confirmed, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Jun, MD,PhD (86-010-88392165, caijun7879@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Office Systolic Blood Pressure (SBP) (time frame: From baseline to Week 8). 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 NCT05608447, 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 8 Nov 2022.