Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Calcium in aortic valve and in coronary arteries assessed by multidetector CT scanner (Agatston units)
研究概览
简要总结
Intervention study focused on preventing the progression of aortic valve calcification.
Vascular and cardiac calcifications are a marker of risk and poor outcome, especially the severe calcified aortic stenosis and coronary calcification.
Its increasing prevalence is now a health problem. The knowledge and the therapeutic objective of this condition have changed in recent years and pathophysiological aspects at present, focus on atherosclerotic disease and inflammation.
Several clinical trials have failed to demonstrate that statins or ACE inhibitors prevent the progression of cardiovascular calcification.
Taking into account the new concepts of ectopic calcification and research results from our group, the most logical approach to prevent progression would be an early intervention and management of the calcification inhibiting agents such as phytate (inositol six-phosphate -- InsP6).
Hypothesis: The phytate prevents or delays the progression of cardiovascular calcification.
It is a clinical trial of intervention of oral phytate (InsP6) in patients with mild to moderate cardiovascular calcification (aortic valve and / or coronary arteries) compared with placebo over a period of 24 months.
It is a prospective, randomized minimization of variables to ensure homogeneity of the groups.
The primary analysis will be the time evolution of the extent of calcium in the aortic valve and coronary arteries made with CT.
Secondary variables are the degree of progression of aortic stenosis and clinical events (death, stroke, angina, stroke and cancer of any type).
详细描述
Main objective of the study:
To evaluate whether the progression of aortic valve calcification and/or coronary arteries in the group treated with oral InsP6 is smaller than in the placebo group, measured by quantification of calcium (score and mass) by multidetector CT to the inclusion in the study and 24 months.
Secondary:
To observe whether the progression of aortic stenosis severity in the intervention group is smaller than in the placebo group, evaluated by echocardiography.
To compare the clinical events between the intervention and placebo groups, measured as the combined event of death, hospitalization for angina, coronary revascularization (surgical or percutaneous), nonfatal myocardial infarction and stroke of any type.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Calcium in the aortic valve, characterized by Rosenhek score grade 2 or 3 in echocardiography and / or with not severe coronary calcification detected in other studies (angiography, CT).
排除标准
- •Severe aortic (Rosenhek 4)or coronary calcification .
- •Positive pregnancy test (if pregnancy occurs during the study be deferred final evaluation at the end of gestation, if the patient wishes to continue in the study).
- •Addiction to drugs or alcohol.
- •Renal insufficiency (serum creatinine> 2mg/dl).
- •Liver disease or cirrhosis.
- •Severe valve disease or requiring surgery during the study.
- •Unstable ischemic heart disease (revascularization in the last 3 months).
- •Atrial fibrillation in the initial evaluation (difficulty in measuring Ca). May be included later if sinus rhythm is achieved stable for at least three months.
- •The need for any medication in relation to calcium metabolism (PTH, bisphosphonates, strontium ranelate, raloxifene, oral calcium, vitamin D, calcitonin, etc.).
- •Participation in another trial in the three months prior to evaluation.
- •Suspected difficulties to accomplish during the two years, for any reason.
研究组 & 干预措施
Phytine (Phytate)
300 mg tid* 24 months
干预措施: Phytine (phytate) (Dietary Supplement)
Phytine (Phytate)
300 mg tid* 24 months
干预措施: Placebo (Dietary Supplement)
Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Calcium in aortic valve and in coronary arteries assessed by multidetector CT scanner (Agatston units)
时间窗: 24 months
次要结局
- Clinical events. A composite event is considered: death, hospitalization for angina, coronary revascularization (surgical or percutaneous), valvular surgery, nonfatal myocardial infarction and stroke.(24 months)