Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications (CALCIFICA)
|ClinicalTrials.gov Identifier: NCT01000233|
Recruitment Status : Unknown
Verified May 2010 by Hospital Universitari Son Dureta.
Recruitment status was: Recruiting
First Posted : October 23, 2009
Last Update Posted : May 26, 2010
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).
|Condition or disease||Intervention/treatment||Phase|
|Heart Valve Disease Aortic Stenosis||Dietary Supplement: Phytine (phytate) Dietary Supplement: Placebo||Phase 2 Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications|
|Study Start Date :||August 2009|
|Estimated Primary Completion Date :||March 2012|
|Estimated Study Completion Date :||October 2012|
U.S. FDA Resources
Active Comparator: Phytine (Phytate)
300 mg tid* 24 months
Dietary Supplement: Phytine (phytate)
300 mg tid * 24 months
Other Names:Dietary Supplement: Placebo
|Placebo Comparator: Placebo||
Dietary Supplement: Placebo
- Calcium in aortic valve and in coronary arteries assessed by multidetector CT scanner (Agatston units) [ Time Frame: 24 months ]
- Clinical events. A composite event is considered: death, hospitalization for angina, coronary revascularization (surgical or percutaneous), valvular surgery, nonfatal myocardial infarction and stroke. [ Time Frame: 24 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01000233
|Contact: Guillem Frontera, MDfirstname.lastname@example.org|
|Contact: Carlos Fernandez_Palomeque, MDemail@example.com|
|Hospital Universitario Son Dureta||Recruiting|
|Palma, Balearic Islands, Spain, 07014|
|Contact: Carlos Fernandez-Palomeque, MD +34971175504 firstname.lastname@example.org|
|Principal Investigator: Carlos Fernandez-Palomeque, MD|
|Sub-Investigator: Guillem Frontera, MD|
|Sub-Investigator: Grases Felix, PhD|
|Sub-Investigator: Bethencourt Armando, Phd MD|
|Sub-Investigator: Joan Alguersuary, MD|
|Sub-Investigator: Josep Francesc Forteza, PhD MD|
|Sub-Investigator: Andres Grau, MD|
|Sub-Investigator: Jose Ignacio Saez de Ibarra, MD|
|Sub-Investigator: Rosa Gonzalez, MD|
|Sub-Investigator: Rafael Prieto, PhD MD|
|Sub-Investigator: Antonia Costa, PhD|
|Sub-Investigator: Onofre Caldes, MD|
|Study Chair:||Guillem Frontera, MD||Hospital Universitario Son Dureta|