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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Hospital Universitari Son Dureta.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Laboratorios BIOMED SA
Information provided by:
Hospital Universitari Son Dureta
ClinicalTrials.gov Identifier:
NCT01000233
First received: October 22, 2009
Last updated: May 25, 2010
Last verified: May 2010
  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

Resource links provided by NLM:


Further study details as provided by Hospital Universitari Son Dureta:

Primary Outcome Measures:
  • Calcium in aortic valve and in coronary arteries assessed by multidetector CT scanner (Agatston units) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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:
  • LITSTOP
  • Inositol hexaphosphate
Dietary Supplement: Placebo
Phytine (Phytate)
Other Names:
  • LITSTOP
  • Inositol hexaphosphate
Placebo Comparator: Placebo Dietary Supplement: Placebo
Phytine (Phytate)
Other Names:
  • LITSTOP
  • Inositol hexaphosphate

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01000233

Contacts
Contact: Guillem Frontera, MD +34971175334 guillem.frontera@ssib.es
Contact: Carlos Fernandez_Palomeque, MD +34971175504 carlos.palomeque@ssib.es

Locations
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         
Sponsors and Collaborators
Hospital Universitari Son Dureta
Laboratorios BIOMED SA
Investigators
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:
Heart Valve Diseases
Aortic Valve Stenosis
Calcinosis
Constriction, Pathologic
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 July 23, 2014