Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2009
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).
Epistemonikos ID: 05a9e57dd7c4afe83f3392bfe727b76f4098068f
First added on: May 05, 2024