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Effect of Vitamin D on Ventricular Remodeling in Patients With Acute Myocardial Infarction (VITDAMI) (VITDAMI)

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ClinicalTrials.gov Identifier: NCT02548364
Recruitment Status : Recruiting
First Posted : September 14, 2015
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
Fondo de Investigacion Sanitaria
Spanish Society of Cardiology
Information provided by (Responsible Party):
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Brief Summary:
To study the effect of calcifediol on left ventricular remodeling, mineral metabolism, plasma levels of several prognostic biomarkers and on endothelial function after an anterior myocardial infarction.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Calcifediol Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicentric, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Effect of Vitamin D on Ventricular Remodeling in Patients With Acute Myocardial Infarction
Study Start Date : October 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Calcifediol
One capsule with 15,690 IU p.o. every two weeks
Drug: Calcifediol
calcifediol treatment
Other Name: vitamin D

Placebo Comparator: Placebo
One capsule with placebo p.o. every two weeks
Drug: Placebo
placebo control group




Primary Outcome Measures :
  1. Change in cardiac remodeling by MRI [ Time Frame: 1 year ]
    It is a composite outcome measure. It will be analyzed by measuring the following parameters: myocardium at risk, size of infarcted myocardium, saved myocardium, ejection fraction, left ventricular telesystolic and telediastolic volumes


Secondary Outcome Measures :
  1. Change in echocardiographic parameters [ Time Frame: 1year ]
    It is a composite outcome measure. It will be analyzed by measuring the following parameters: ventricular thickness and diameters, contractility abnormalities, ejection fraction.

  2. Change in mineral metabolism parameters [ Time Frame: 1 year ]
    It is a composite outcome measure. It will be analyzed by measuring plasma levels of calcidiol, FGF-23, klotho, phosphate, and PTH

  3. Change in prognostic biomarkers levels [ Time Frame: 1 year ]
    It is a composite outcome measure. It will be analyzed by measuring plasma levels of NT-proBNP, hsCRP, MCP-1 and galectin-3

  4. Change in lipid levels [ Time Frame: 1 year ]
    It is a composite outcome measure. It will be analyzed by measuring plasma levels of TC, LDL, HDL, TG and non-HDL Cholesterol

  5. Change in flow mediated vasodilation [ Time Frame: 1 year ]
  6. Adverse event rate [ Time Frame: 1.5, 3, 6, 9, 12 and 13 months ]
  7. % of treatment compliance [ Time Frame: 3, 6, 9 and 12 months ]


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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 40 years and maximum 85 years.
  • Anterior myocardial infarction
  • Sign informed consent

Exclusion Criteria:

  • Death during the index event
  • Age younger than 40 or older than 85 years
  • Previous Infarction
  • More than 7 days in hospitalization
  • Systemic inflammatory or autoimmune disease
  • Concomitant disorders limiting survival
  • Concomitant cardiomyopathy
  • Left ventricular hypertrophy > 16mm in females and > 17mm in males
  • eGFR<45
  • LVEF<30
  • Incomplete revascularization
  • Valvular prosthesis
  • Aortic stenosis with mean gradient> 25 mmHg
  • Moderate or severe valvular regurgitation
  • Hypersensitivity or intolerance vitamin D supplement o excipient
  • Blood Calcium >10.5 mg/dl
  • Inability to follow.
  • Difficulty in treatment compliance
  • Contraindication for MRI, including indication to place a cardiac device
  • Indication of therapy with vitamin D. Patient desires to take vitamin D.
  • Drugs or conditions that interfere with the pharmacokinetics of calcifediol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02548364


Contacts
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Contact: Jose Tuñón, MD 0034915504800 ext 3701 jtunon@fjd.es
Contact: ALVARO ACEÑA, MD 0034915504800 ext 3702 aacena@fjd.es

Locations
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Spain
Hospital de Fuenlabrada Not yet recruiting
Fuenlabrada, Madrid, Spain
Contact: Carmen Cristobal, MD       carmencristobalv@gmail.com   
Hospital Universitario de Getafe Active, not recruiting
Getafe, Madrid, Spain, 28905
Hospital Puerta de Hierro Not yet recruiting
Majadahonda, Madrid, Spain
Contact: Juan Manuel Escudier, MD       jescudiervilla@yahoo.es   
Hospital Rey Juan Carlos Recruiting
Mostoles, Madrid, Spain, 28933
Contact: Petra Sanz, MD       petra.sanz@hospitalreyjuancarlos.es   
Hospital de Móstoles Not yet recruiting
Móstoles, Madrid, Spain
Contact: Nieves Tarin, MD       nieves.tarin@salud.madrid.org   
Hospital Infanta Elena Recruiting
Valdemoro, Madrid, Spain, 28342
Contact: Petra Sanz, MD         
Fundación Jiménez Díaz Recruiting
Madrid, Spain, 28040
Contact: Jose Tuñon, MD, PhD    915504800 ext 3701    jtunon@fjd.es   
Contact: Raquel Muñoz, Pharmacy    +34 915504800 ext 3214    rmunozs@fjd.es   
Principal Investigator: Jose Tuñon, MD, PhD         
Sub-Investigator: Alvaro Aceña Aceña, MD         
Sub-Investigator: Paula Beltran, MD         
Sponsors and Collaborators
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Fondo de Investigacion Sanitaria
Spanish Society of Cardiology
Investigators
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Principal Investigator: JOSE TUÑON, MD, PhD IIS-FJD

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
ClinicalTrials.gov Identifier: NCT02548364     History of Changes
Other Study ID Numbers: FJD-VITDAMI-14-01
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Keywords provided by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz:
Vitamin D
Myocardial Infarction
Ventricular remodeling
Biomarkers
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ventricular Remodeling
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pathological Conditions, Anatomical
Vitamin D
Ergocalciferols
Calcifediol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents