Status:
UNKNOWN
Effect of Gut Microbiome Restoration on Primary Hypertension Via FMT
Lead Sponsor:
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborating Sponsors:
National Natural Science Foundation of China
Conditions:
Hypertension
Eligibility:
All Genders
18-60 years
Phase:
EARLY_PHASE1
Brief 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/...
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. Sev...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 \[TIA\])
- 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.
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04406129
Start Date
March 17 2021
End Date
September 1 2022
Last Update
July 16 2021
Active Locations (7)
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1
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100037
2
The Second Affiliated Hospital of Shantou University
Shantou, Guangdong, China
3
Qilu Hospital of Shandong University
Jinan, Shandong, China
4
Shanxi Bethune Hospital
Taiyuan, Shanxi, China