Study on the Role of a Combination of Nutraceuticals (Armolipid Prev) With an Effect on Blood Pressure and Lipids in the Control of Cardiovascular Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Cardiovascular risk
研究概览
简要总结
Cardiovascular risk has been shown to increase with increasing blood pressure values. As a consequence, it results mandatory to achieve lower blood pressure goals in all hypertensive patients, taking into account that all drugs always have some side effects that can be very dangerous and/or uncomfortable for the patients leading to a reduced compliance. Thus, pharmacological treatment should be delayed until it results really necessary.
The availability of natural substances with a therapeutic action has modified this scenario because of their reduced potential to cause undesirable effects (compared with drugs). In order to choose among various nutraceuticals (natural foods compounds with health benefits, including the prevention and/or treatment of diseases), preference should be given to those
- produced according to the same Good Manufacturing Practice used for drugs, to be sure that the finished product has a standard, reproducible composition
- for which efficacy and safety in the recommended indications are supported by clinical trials.
An example of a product with these characteristics is Armolipid Plus, a combination of nutraceuticals with a demonstrated anti-dyslipidaemic effect. Recently, a large clinical intervention study showed evidence that treatment with Armolipid Plus leads to a significant decrease in the overall cardiovascular risk, measured using the Framingham Risk Score.
Progress in Research and Development in this field has led to a new patented and registered combination of nutraceuticals: Armolipid Prev, containing orthosiphon and CoQ10, with antihypertensive activity, berberine, red yeast, policosanol and orthosiphon with antidyslipidaemic effect and folic acid, reducing plasma homocysteine levels.
In addition to the established anti-dyslipidaemic activity of Armolipid plus, Armolipid Prev has a significant antihypertensive effect, which is beneficial in all those patients with high blood pressure values without a defined indication to begin a pharmacological treatment according to the current guidelines. The antihypertensive effect of Armolipid Prev, documented by ambulatory blood pressure monitoring, in addition to the lowering effect on dyslipidaemia and even on abdominal girth, represents a new opportunity for complete and early, effective and safe cardiovascular disease prevention.
详细描述
Study on the role of a combination of nutraceuticals (Armolipid Prev) with an effect on blood pressure and lipids in the control of cardiovascular risk.
APv - cpr - 0210
- Study rationale The strategies for the prevention of cardiovascular diseases always involve correction of wrong lifestyle habits, whereas use of pharmacological treatments is recommended only in patients with a high cardiovascular risk.
This approach obviously leaves off a wide proportion of the population at low-moderate cardiovascular risk that could benefit from early BP-lowering treatment before development of organ damage or before it become irreversible, because in high-risk hypertensive patients, even intense cardiovascular therapy, through beneficial, is nonetheless unable to lower total cardiovascular risk below the high risk threshold.
In the setting of cardiovascular prevention, presence of metabolic syndrome results particularly relevant, since it affects a large percentage of population and it has been demonstrated to increase the risk of cardiovascular events.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with diagnosis of metabolic syndrome and requiring a blood pressure reduction without any indication to start a pharmacological therapy or in whom stable drug therapy has not achieved the desired results
- •The presence of at least 3 of the following 5 factors:
- •increased blood pressure (≥ 130/85 and ≤ 140/90 mmHg)
- •serum triglycerides ³150 mg/dL
- •serum HDL cholesterol ≤ 40 mg/dL (males), ≤ 50 mg/dL (females)
- •abdominal girth ≥ 104 cm (males), ≥ 88 cm (females)
- •elevated fasting blood glucose ≥ 100 mg/dL
排除标准
- •Diabetics or hypertensive subjects with an indication to start a pharmacological therapy
- •Patients under lipid-lowering treatment
- •Pregnant or breast-feeding women according to the Package Leaflet
- •Patients who require cholesterol-lowering drug therapy in accordance with the international guidelines will not be included in the study population
研究组 & 干预措施
placebo
干预措施: Armolipid Prev (Drug)
结局指标
主要结局
Cardiovascular risk
时间窗: 12 months
Reduction the global cardiovascular risk calculated according to Framingham risk score compared to baseline. Reduction of incident metabolic syndrome defined according to ATPIII criteria compared to baseline. Reduction of the prevalence of microalbuminuria evaluated by standard methods compared to baseline. Reduction of the prevalence of left ventricular hypertrophy evaluated by the ECG using the current ECG criteria (the Sokolow-Lyon index) compared to baseline.
次要结局
- Life style(12 months)
研究者
Bruno Trimarco
Full Professor of Cardiology
Federico II University