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

NCT01000233 | Unknown Phase 2

• 1 other identifier: FIS_PI081931
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Heart Valve Disease; Aortic Stenosis

Keywords

PATOLOGIC CALCIFICATION; AORTIC VALVE STENOSIS; INOSITOL HEXAPHOSPHATE

Outcome Measures

Primary Outcomes (1)

• Calcium in aortic valve and in coronary arteries assessed by multidetector CT scanner (Agatston units)

  24 months

Secondary Outcomes (1)

• 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

Study Arms (2)

Phytine (Phytate)

ACTIVE COMPARATOR

300 mg tid\* 24 months

Dietary Supplement: Phytine (phytate); Dietary Supplement: Placebo

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Phytine (phytate) DIETARY_SUPPLEMENT

300 mg tid \* 24 months

Also known as: LITSTOP, Inositol hexaphosphate

Phytine (Phytate)

Placebo DIETARY_SUPPLEMENT

Phytine (Phytate)

Also known as: LITSTOP, Inositol hexaphosphate

Phytine (Phytate); Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Son Dureta: lead
• Laboratorios BIOMED SA: collaborator

Study Sites (1)

Hospital Universitario Son Dureta

Palma, Balearic Islands, 07014, Spain

RECRUITING

Related Publications (4)

• Grases F, Prieto RM, Simonet BM, March JG. Phytate prevents tissue calcifications in female rats. Biofactors. 2000;11(3):171-7. doi: 10.1002/biof.5520110303.

  PMID: 10875304 BACKGROUND

• Grases F, Sanchis P, Perello J, Isern B, Prieto RM, Fernandez-Palomeque C, Saus C. Phytate reduces age-related cardiovascular calcification. Front Biosci. 2008 May 1;13:7115-22. doi: 10.2741/3214.

  PMID: 18508720 BACKGROUND

• Grases F, Sanchis P, Costa-Bauza A, Bonnin O, Isern B, Perello J, Prieto RM. Phytate inhibits bovine pericardium calcification in vitro. Cardiovasc Pathol. 2008 May-Jun;17(3):139-45. doi: 10.1016/j.carpath.2007.08.005. Epub 2007 Oct 24.

  PMID: 18402805 BACKGROUND

• Grases F, Sanchis P, Perello J, Isern B, Prieto RM, Fernandez-Palomeque C, Torres JJ. Effect of crystallization inhibitors on vascular calcifications induced by vitamin D: a pilot study in Sprague-Dawley rats. Circ J. 2007 Jul;71(7):1152-6. doi: 10.1253/circj.71.1152.

  PMID: 17587727 BACKGROUND

MeSH Terms

Conditions

Heart Valve Diseases; Aortic Valve Stenosis

Interventions

Phytic Acid

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Inositol Phosphates; Inositol; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Sugar Phosphates

Study Officials

• Guillem Frontera, MD

  Hospital Universitario Son Dureta

  STUDY CHAIR

Central Study Contacts

Guillem Frontera, MD

CONTACT

+34971175334; guillem.frontera@ssib.es

Carlos Fernandez_Palomeque, MD

CONTACT

+34971175504; carlos.palomeque@ssib.es

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 22, 2009
• First Posted: October 23, 2009
• Study Start: August 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 26, 2010

Record last verified: 2010-05

Locations

ES (1)