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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Calcifediol
Placebo
Sponsored by
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Vitamin D, Myocardial Infarction, Ventricular remodeling, Biomarkers

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Fuenlabrada
  • Hospital Universitario de Getafe
  • Hospital Puerta de Hierro
  • Hospital Rey Juan Carlos
  • Hospital de Móstoles
  • Hospital Infanta Elena
  • Fundación Jiménez Díaz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Calcifediol

Placebo

Arm Description

One capsule with 15,690 IU p.o. every two weeks

One capsule with placebo p.o. every two weeks

Outcomes

Primary Outcome Measures

Change in cardiac remodeling by MRI
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

Change in echocardiographic parameters
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
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
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
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
Adverse event rate
% of treatment compliance

Full Information

First Posted
July 6, 2015
Last Updated
October 2, 2023
Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborators
Fondo de Investigacion Sanitaria, Spanish Society of Cardiology
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1. Study Identification

Unique Protocol Identification Number
NCT02548364
Brief Title
Effect of Vitamin D on Ventricular Remodeling in Patients With Acute Myocardial Infarction (VITDAMI)
Acronym
VITDAMI
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 Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
May 2023 (Actual)
Study Completion Date
May 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborators
Fondo de Investigacion Sanitaria, Spanish Society of Cardiology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Vitamin D, Myocardial Infarction, Ventricular remodeling, Biomarkers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calcifediol
Arm Type
Experimental
Arm Description
One capsule with 15,690 IU p.o. every two weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One capsule with placebo p.o. every two weeks
Intervention Type
Drug
Intervention Name(s)
Calcifediol
Other Intervention Name(s)
vitamin D
Intervention Description
calcifediol treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo control group
Primary Outcome Measure Information:
Title
Change in cardiac remodeling by MRI
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in echocardiographic parameters
Description
It is a composite outcome measure. It will be analyzed by measuring the following parameters: ventricular thickness and diameters, contractility abnormalities, ejection fraction.
Time Frame
1year
Title
Change in mineral metabolism parameters
Description
It is a composite outcome measure. It will be analyzed by measuring plasma levels of calcidiol, FGF-23, klotho, phosphate, and PTH
Time Frame
1 year
Title
Change in prognostic biomarkers levels
Description
It is a composite outcome measure. It will be analyzed by measuring plasma levels of NT-proBNP, hsCRP, MCP-1 and galectin-3
Time Frame
1 year
Title
Change in lipid levels
Description
It is a composite outcome measure. It will be analyzed by measuring plasma levels of TC, LDL, HDL, TG and non-HDL Cholesterol
Time Frame
1 year
Title
Change in flow mediated vasodilation
Time Frame
1 year
Title
Adverse event rate
Time Frame
1.5, 3, 6, 9, 12 and 13 months
Title
% of treatment compliance
Time Frame
3, 6, 9 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JOSE TUÑON, MD, PhD
Organizational Affiliation
IIS-FJD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Fuenlabrada
City
Fuenlabrada
State/Province
Madrid
Country
Spain
Facility Name
Hospital Universitario de Getafe
City
Getafe
State/Province
Madrid
ZIP/Postal Code
28905
Country
Spain
Facility Name
Hospital Puerta de Hierro
City
Majadahonda
State/Province
Madrid
Country
Spain
Facility Name
Hospital Rey Juan Carlos
City
Mostoles
State/Province
Madrid
ZIP/Postal Code
28933
Country
Spain
Facility Name
Hospital de Móstoles
City
Móstoles
State/Province
Madrid
Country
Spain
Facility Name
Hospital Infanta Elena
City
Valdemoro
State/Province
Madrid
ZIP/Postal Code
28342
Country
Spain
Facility Name
Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
27496232
Citation
Tunon J, Gonzalez-Hernandez I, Llanos-Jimenez L, Alonso-Martin J, Escudier-Villa JM, Tarin N, Cristobal C, Sanz P, Pello AM, Acena A, Carda R, Orejas M, Tomas M, Beltran P, Calero Rueda M, Marcos E, Serrano-Antolin JM, Gutierrez-Landaluce C, Jimenez R, Cabezudo J, Curcio A, Peces-Barba G, Gonzalez-Parra E, Munoz-Siscart R, Gonzalez-Casaus ML, Lorenzo A, Huelmos A, Goicolea J, Ibanez B, Hernandez G, Alonso-Pulpon LM, Farre J, Lorenzo O, Mahillo-Fernandez 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.
Results Reference
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Effect of Vitamin D on Ventricular Remodeling in Patients With Acute Myocardial Infarction (VITDAMI)

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