Role of vitamin D administration in heart failure patients

Phase IV randomized, double blind, placebo-controlled study: role of hypovitaminosis D in heart failure and possible advantages of cholecalciferol (Vit D) administration - DLIFE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004592-23-IT

Enrollment

Registered

2015-05-21

Start date

2015-03-12

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HEART FAILURE MedDRA version: 18.0 Level: LLT Classification code 10011949 Term: Decompensation cardiac System Organ Class: 100000004849

Interventions

Trade Name: DIBASE - 10.000 UI/ML GOCCE ORALI, SOLUZIONE FLACONE CON GONTACOCCE 10 ML Pharmaceutical Form: Oral drops, solution INN or Proposed INN: COLECALCIFEROLO CAS Number: 67-97-0 Other descrip

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients who belong to the Service of Cardiology at Fondazione Toscana G. Monasterio - Diagnosis of heart failure (NYHA class II-III) - Optimized heart failure therapy according to clinical practice - Medical conditions stable without change of heart medicine for at least 3 months - Capacity / ability to perform the CPET - Age> 18 years - Sex female and male - Signing of the informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: - BMI>30 - Primary or secondary to kidney failure Hyperparathyroidism - Phospho-calcic metabolism alterations/diseases - History of pulmonary embolism - Moderate-to-severe aortic and mitral stenosis - Pericardial disease - Severe obstructive lung disease - Exercise-induced angina and significant ECG alterations - Incapacity - Pregnancy, lactation - Cholecalciferol or expients intolerance - Hypercalcemia/hypercalciuria - Kidney stones (nephrolithiasis/nephrocalcinosis) - Chronic kidney failure - Current therapy, or place within three months prior to the study, along with other vitamin D analogs - Use of anticonvulsants or barbiturates.

Design outcomes

Primary

Measure	Time frame
Main Objective: Assessment of cardiopulmonary test (CPET) paramethers improvement, after cholecalciferol administration with standard doses, for 6 months, in patients with heart failure (NHYA II and III);Secondary Objective: - Correlation between CPET paramethers and 25OHvitamin D basal levels, in heart failure patients - Assessment of clinical improvement of patients with heart failure after cholecalciferol (vitamin D) administration for 6 months - Assessment of improvements in heart failure outcome biomarkers, after cholecalciferol (vitamin D) administration for 6 months;Primary end point(s): Performance of the parameters of cardiopulmonary exercise testing (CPET) after 6 months of treatment. Instruments to be used: Cardiopulmonary exercise testing (CPET) performed as per routine clinical practice. The parameters used are mainly the assessment of metabolic response indices such as VO2 and VE / VCO2. Among the many parameters that can be evaluated with the CPET, the latter have been identified and validated in the literature as the best predictors of prognosis in heart failure.;Timepoint(s) of evaluation of this end point: 6 month	—

Measure

Time frame

Main Objective: Assessment of cardiopulmonary test (CPET) paramethers improvement, after cholecalciferol administration with standard doses, for 6 months, in patients with heart failure (NHYA II and III);Secondary Objective: - Correlation between CPET paramethers and 25OHvitamin D basal levels, in heart failure patients - Assessment of clinical improvement of patients with heart failure after cholecalciferol (vitamin D) administration for 6 months - Assessment of improvements in heart failure outcome biomarkers, after cholecalciferol (vitamin D) administration for 6 months;Primary end point(s): Performance of the parameters of cardiopulmonary exercise testing (CPET) after 6 months of treatment. Instruments to be used: Cardiopulmonary exercise testing (CPET) performed as per routine clinical practice. The parameters used are mainly the assessment of metabolic response indices such as VO2 and VE / VCO2. Among the many parameters that can be evaluated with the CPET, the latter have been identified and validated in the literature as the best predictors of prognosis in heart failure.;Timepoint(s) of evaluation of this end point: 6 month

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Secondary

Measure	Time frame
Secondary end point(s): 1-Prevention of 25OHD deficiency and correction of the levels of 25OHD. Instruments to be used: 25OHD assay with mass spectrometry, a method of last generation that has already shown, in preliminary studies (see background), greater accuracy than conventional methods 2-Prevalence of hypovitaminosis D in the general population suffers from congestive heart failure and correlation with clinical and instrumental data. 3-Performance of clinical signs after 6 months of treatment. Instruments to be used: anamnesis, physical examination and general cardiology, self-assessment questionnaires. 4-Development of instrumental and biochemical parameters after 6 months of treatment. Tools to use: Dosage of hemoglobin, electrolytes, creatinine, glomerular filtration rate, renin directly, aldosterone, catecholamines, NT-proBNP, ECG, echocardiography (especially left ventricular volumes and systolic diastolic);Timepoint(s) of evaluation of this end point: 1, 2, 3, 4- 6 month	—

Measure

Time frame

Secondary end point(s): 1-Prevention of 25OHD deficiency and correction of the levels of 25OHD. Instruments to be used: 25OHD assay with mass spectrometry, a method of last generation that has already shown, in preliminary studies (see background), greater accuracy than conventional methods 2-Prevalence of hypovitaminosis D in the general population suffers from congestive heart failure and correlation with clinical and instrumental data. 3-Performance of clinical signs after 6 months of treatment. Instruments to be used: anamnesis, physical examination and general cardiology, self-assessment questionnaires. 4-Development of instrumental and biochemical parameters after 6 months of treatment. Tools to use: Dosage of hemoglobin, electrolytes, creatinine, glomerular filtration rate, renin directly, aldosterone, catecholamines, NT-proBNP, ECG, echocardiography (especially left ventricular volumes and systolic diastolic);Timepoint(s) of evaluation of this end point: 1, 2, 3, 4- 6 month

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Countries

Italy

Contacts

Public ContactU.O.ENDOCRINOLOGIA 2

AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA

claudio.marcocci@med.unipi050995001

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026