Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications (CALCIFICA)
Recruitment status was Recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Heart Valve Disease Aortic Stenosis |
Dietary Supplement: Phytine (phytate) Dietary Supplement: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications |
- Calcium in aortic valve and in coronary arteries assessed by multidetector CT scanner (Agatston units) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 250 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Phytine (Phytate)
300 mg tid* 24 months
|
Dietary Supplement: Phytine (phytate)
300 mg tid * 24 months
Other Names:
Dietary Supplement: Placebo
Phytine (Phytate)
Other Names:
|
| Placebo Comparator: Placebo |
Dietary Supplement: Placebo
Phytine (Phytate)
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Guillem Frontera, MD | +34971175334 | guillem.frontera@ssib.es |
| Contact: Carlos Fernandez_Palomeque, MD | +34971175504 | carlos.palomeque@ssib.es |
| Spain | |
| Hospital Universitario Son Dureta | Recruiting |
| Palma, Balearic Islands, Spain, 07014 | |
| Contact: Carlos Fernandez-Palomeque, MD +34971175504 carlos.palomeque@ssib.es | |
| 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 |
More Information
Publications:
| Responsible Party: | Carlos Fernandez-Palomeque, Hospital Universitari Son Dureta |
| ClinicalTrials.gov Identifier: | NCT01000233 History of Changes |
| Other Study ID Numbers: | FIS_PI081931 |
| Study First Received: | October 22, 2009 |
| Last Updated: | May 25, 2010 |
| Health Authority: | Spain: Ministry of Health |
Keywords provided by Hospital Universitari Son Dureta:
|
PATOLOGIC CALCIFICATION AORTIC VALVE STENOSIS INOSITOL HEXAPHOSPHATE |
Additional relevant MeSH terms:
|
Aortic Valve Stenosis Calcinosis Constriction, Pathologic Heart Valve Diseases Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction Calcium Metabolism Disorders Metabolic Diseases |
Pathological Conditions, Anatomical Inositol Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013