Status:
UNKNOWN
Effect of Gut Microbiome Restoration on Primary Hypertension Via Dietary Intervention
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 optimal role of diets (i.e. DASH (Dietary Approaches to Stop Hypertension) diet, Mediterranean diet) on BP control and a causal role of gut ...
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 :
July 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04403347
Start Date
July 8 2021
End Date
September 30 2023
Last Update
October 24 2022
Active Locations (4)
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1
First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
2
Second Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
3
Clinical Medical College&Affiliated Hospital of Chengdu University
Chengdu, Sichuan, China
4
First Affiliated Hospital of Chongqing Medical University
Chongqing, China