Spermidine Anti-Hypertension Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Systolic blood pressure in an ambulatory 24h blood pressure measurement
研究概览
简要总结
The impact of daily spermidine application on arterial blood pressure and other secondary parameters will be evaluated in a double-blind single center 46 patients cross-over study.
详细描述
Arterial hypertension is a central risk factor for cardiovascular disease, major cardiovascular events and mortality. Treatment of arterial hypertension necessitates lifestyle modifications, but often also requires medical intervention. In most cases, a combination of two or more anti-hypertensive drugs is recommended and necessary for reaching the target blood pressure levels.
Hypotheses / research questions/objectives Spermidine potentiates the blood pressure lowering effect of standard anti-hypertensive medications, particularly when a combination of at least two first-line drugs (as recommended by the European Society of Cardiology guidelines) has not resulted in sufficient and adequate blood pressure control.
Approach/methods Spermidine Anti-Hypertension Study (SMARTEST) is a prospective, randomized and double-blind placebo-controlled single-centre trial with a balanced 2x2 crossover design, where 46 medically pre-treated hypertensive patients will be subsequently treated with spermidine and placebo (each for eight weeks) in two arms of opposite treatment sequence. A washout period of four weeks will separate the two intervention periods in both arms.
Patients will undergo physical examination, ECG (electrocardiogram), echocardiography, and blood draws at four time points coinciding with the baseline and termination of each treatment at: 0, 8, 12, and 20 weeks of/after recruitment at the Department of Cardiology, Medical University of Graz. In addition, 24-hour ambulatory blood pressure (24-h BP) monitoring (BPM; Mobil-O-Graph®) and on-site blood pressure will be obtained (the device will be sent back to the hospital the following day) at these time points. A 6-minute walk test (6MWT) will be performed at every visit.
Spermidine will be administered orally as an approved dietary supplement (spermidine-rich wheat germ extract) at a dose of 4 mg spermidine per day for eight weeks. The primary outcome will be arterial systolic blood pressure at 24h BPM. Further secondary outcomes/safety outcomes will be:
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide signed and dated informed consent form
- •Persistant arterial hypertension with systolic blood pressure above 150 mmHg during hospitalisation and the day of randomisation
- •Stable anti-hypertensive medication with at least two guideline-recommended anti-hypertensive drugs
排除标准
- •Systolic blood pressure ≥180mmHg on the day of randomisation
- •Spermidine intolerance
- •Significant renal impairment defined as glomerular filtration rate < 45ml/min
- •Insulin-dependent diabetes mellitus (IDDM)
- •Wheat allergy or gluten intolerance
- •Life expectancy of less than 12 months
- •Participation in another clinical trial
研究组 & 干预措施
Spermidine first
First treatment period (8 weeks) will be 4 mg spermidine per day orally. Afterwards 4 weeks of wash-out followed by 8 weeks of placebo treatment.
干预措施: Placebo (Drug)
Spermidine first
First treatment period (8 weeks) will be 4 mg spermidine per day orally. Afterwards 4 weeks of wash-out followed by 8 weeks of placebo treatment.
干预措施: Spermidine (Drug)
Placebo first
First treatment period (8 weeks) will be placebo. Afterwards 4 weeks of wash-out followed by 8 weeks of 4 mg spermidine per day orally.
干预措施: Placebo (Drug)
Placebo first
First treatment period (8 weeks) will be placebo. Afterwards 4 weeks of wash-out followed by 8 weeks of 4 mg spermidine per day orally.
干预措施: Spermidine (Drug)
结局指标
主要结局
Systolic blood pressure in an ambulatory 24h blood pressure measurement
时间窗: up to 24 weeks
Patients will get RR recordings in an ambulatory setting
次要结局
- diastolic blood pressure(up to 24 weeks)
- mean blood pressure(up to 24 weeks)
- 6 minute walk test(up to 24 weeks)
- Pulse wave velocity(up to 24 weeks)
- central blood pressure(up to 24 weeks)