Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Blood Pressure
研究概览
简要总结
This study is designed to investigate whether sympathoinhibition with moxonidine could provide added metabolic benefit compared to the second line therapy in the current guidelines.
详细描述
This is a randomised, double-blind, cross-over study. Participants will be randomly assigned to receive either moxonidine 0.4mg daily or amlodipine 5mg and will later receive the alternate treatment.
Comprehensive testing will occur after each 12 week treatment phase and will include assessment of muscle sympathetic nerve activity, gut microbiome analysis and metabolic markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 25 -70 years
- •(Body Mass Index) BMI≥30kg/m2
- •Currently weight stable (+/- 3% in previous 6-12 months and not on any specific exercise or dietary program)
- •Elevated clinic systolic (Blood Pressure) BP ≥135 or diastolic BP ≥85mmHg,
- •on ACE inhibitor for at least 6 weeks prior to baseline assessment
排除标准
- •Grade 2-3 hypertension (systolic office BP >160, diastolic office BP >100 mmHg)
- •Secondary causes of hypertension
- •CKD (Chronic kidney disease) stage 4-5 {(estimated glomerular filtration) eGFR<30ml/min}
- •Heart failure NYHA (New York Heart Association) class II-IV
- •Recent CV (cardiovascular) event (acute myocardial infarction, acute coronary syndrome, stroke or transient ischaemic attack within the previous six months) unstable psychiatric condition
- •medication such as corticosteroids, several antidepressants and antipsychotics
- •Female participants of childbearing potential must have a negative pregnancy test prior to treatment
研究组 & 干预措施
Phase 1
Moxonidine 0.4mg/daily
干预措施: Moxonidine 0.4 MG (Drug)
Phase 1
Moxonidine 0.4mg/daily
干预措施: Amlodipine 5mg (Drug)
Phase 2
Amlodipine 5mg
干预措施: Moxonidine 0.4 MG (Drug)
Phase 2
Amlodipine 5mg
干预措施: Amlodipine 5mg (Drug)
结局指标
主要结局
Blood Pressure
时间窗: 30 weeks
Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring
次要结局
- blood glucose levels(30 weeks)
- Gut microbiota profile(30 weeks)
- Lipid levels in blood(30 weeks)
研究者
Dr Markus Schlaich
Principal Investigator
Royal Perth Hospital