Status:
UNKNOWN
Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications
Lead Sponsor:
Hospital Universitari Son Dureta
Collaborating Sponsors:
Laboratorios BIOMED SA
Conditions:
Heart Valve Disease
Aortic Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 aort...
Detailed Description
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, meas...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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).
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2012
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT01000233
Start Date
August 1 2009
End Date
October 1 2012
Last Update
May 26 2010
Active Locations (1)
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1
Hospital Universitario Son Dureta
Palma, Balearic Islands, Spain, 07014