Heart failure is a condition that occurs when the heart loses its normal ability to pump blood to maintain vital body functions and, therefore, works with lower efficiency. Several studies have shown that deficiency of vitamin D would delete the renin gene, regulate the myocytes growth and facilitate ventricular hypertrophy, favoring cardiovascular damage and the incidence of heart failure. MedDRA version: 14.1 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class:
Conditions
Interventions
Trade Name: DIBASE*IM OS 6F 1ML 100000UI/M
Pharmaceutical Form: Oral solution
INN or Proposed INN: VITAMIN D NOS
CAS Number: 8000055643
Current Sponsor code: NA
Other descriptive name: NA
Concentratio
Sponsors
A.O. UNIVERSITARIA INTEGRATA DI VERONA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Written informed consent signed by the patient or by a legally acceptable representative; -Men and women between the ages of 40 and 85 years; -Patients affected by chronic heart failure (Framingham criteria), not in the acute phase, in NYHA class I-II-III-IV secondary to a hypertensive ischemic heart disease or an idiopathic dilated cardiomyopathy, and with echocardiographic assessment of both systolic heart failure (left ventricular ejection fraction = 50%) and heart failure with preserved systolic function (ejection fraction equal or > 45%, evidence of abnormal left ventricular relaxation); -Nutritional deficiency of Vitamin D (VIT D 10 ng/mL). Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 36
Exclusion criteria
Exclusion criteria: -unstable angina; -recent myocardial infarction (within the 6 months prior to enrollment) -cardiogenic shock or hypotension (systolic pressure 180, DBP> 110); -severe liver disease -severe renal impairment (creatinine> 2mg/dl); -infectious or chronic inflammatory disease; -active cancer or haematological disease; -recent blood transfusion (within 30 days); -abuse of alcohol or drugs in the last year; -severe osteoporosis requiring treatment with bisphosphonates and / or vitamin D; -intake of vitamin D within the 3 months prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the relationship between low serum levels of vitamin D and increased incidence of heart failure argued by the literature.;Secondary Objective: To verify the effectiveness of the additional therapy with vitamin D, proofing an improvement of cardiac contractility indices by an echocardiographic study and a reduction of cardiac fibrosis.;Primary end point(s): EF (ejection fraction) % (B-mode measurement) measured by echocardiogram;Timepoint(s) of evaluation of this end point: nd | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.wall thickness (IVS and PW) in mm (M-mode measurement) left ventricular mass index calculated by: 0.832* [(Dd+IVSd+PWd)3 – Dd3] + 0.6g (Dd is the left ventricular telediastolic diameter, IVS is the interventricular septum thickness, PWd is the diastolic posterior wall thickness) 2.Parameters of relaxation (E/A ratio) 3.DT in mm/sec 4.Serum carboxy-terminal propeptide of procollagen type I;Timepoint(s) of evaluation of this end point: nd | — |
Countries
Italy
Contacts
Public ContactReparto di Medicina C
Azienda Ospedaliera Universitaria Integrata Verona
Outcome results
None listed