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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

Tracking Information
First Submitted Date  ICMJE July 6, 2015
First Posted Date  ICMJE September 14, 2015
Last Update Posted Date August 14, 2019
Study Start Date  ICMJE October 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02548364 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2015)
  • 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.
  • 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
  • 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
  • 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
  • Change in flow mediated vasodilation [ Time Frame: 1 year ]
  • Adverse event rate [ Time Frame: 1.5, 3, 6, 9, 12 and 13 months ]
  • % of treatment compliance [ Time Frame: 3, 6, 9 and 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Vitamin D on Ventricular Remodeling in Patients With Acute Myocardial Infarction (VITDAMI)
Official Title  ICMJE Multicentric, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Effect of Vitamin D on Ventricular Remodeling in Patients With Acute Myocardial Infarction
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE
  • Drug: Calcifediol
    calcifediol treatment
    Other Name: vitamin D
  • Drug: Placebo
    placebo control group
Study Arms  ICMJE
  • Experimental: Calcifediol
    One capsule with 15,690 IU p.o. every two weeks
    Intervention: Drug: Calcifediol
  • Placebo Comparator: Placebo
    One capsule with placebo p.o. every two weeks
    Intervention: Drug: Placebo
Publications * Tuñón J, González-Hernández I, Llanos-Jiménez L, Alonso-Martín J, Escudier-Villa JM, Tarín N, Cristóbal C, Sanz P, Pello AM, Aceña Á, Carda R, Orejas M, Tomás M, Beltrán P, Calero Rueda M, Marcos E, Serrano-Antolín JM, Gutiérrez-Landaluce C, Jiménez R, Cabezudo J, Curcio A, Peces-Barba G, González-Parra E, Muñoz-Siscart R, González-Casaus ML, Lorenzo A, Huelmos A, Goicolea J, Ibáñez B, Hernández G, Alonso-Pulpón LM, Farré J, Lorenzo Ó, Mahíllo-Fernández I, Egido J. Design and rationale of a multicentre, randomised, double-blind, placebo-controlled clinical trial to evaluate the effect of vitamin D on ventricular remodelling in patients with anterior myocardial infarction: the VITamin D in Acute Myocardial Infarction (VITDAMI) trial. BMJ Open. 2016 Aug 5;6(8):e011287. doi: 10.1136/bmjopen-2016-011287.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 10, 2015)
144
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jose Tuñón, MD 0034915504800 ext 3701 jtunon@fjd.es
Contact: ALVARO ACEÑA, MD 0034915504800 ext 3702 aacena@fjd.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02548364
Other Study ID Numbers  ICMJE FJD-VITDAMI-14-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Study Sponsor  ICMJE Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborators  ICMJE
  • Fondo de Investigacion Sanitaria
  • Spanish Society of Cardiology
Investigators  ICMJE
Principal Investigator: JOSE TUÑON, MD, PhD IIS-FJD
PRS Account Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP