EFFECT OF VITAMIN D ON THE VENTRICULAR FUNCTION IN PATIENTS WITH HEART FAILURE

EFFECT OF VITAMIN D SUPPLEMENTATION ON THE VENTRICULAR DEFORMATION RATE (STRAIN RATE) IN PATIENTS WITH HEART FAILURE WITH PRESERVED OR MODERATELY REDUCED EYECTION FRACTION

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001488-21-ES

Enrollment

102

Registered

2018-07-17

Start date

2018-11-06

Completion date

Unknown

Last updated

2019-12-10

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

Conditions

Heart failure with preserved or moderately reduced eyection fraction

Interventions

Trade Name: HIDROFEROL Product Name: Hidroferol Pharmaceutical Form: Oral liquid INN or Proposed INN: CALCIFEDIOL CAS Number: 19356-17-3 Other descriptive name: HIDROFEROL Concentration unit: mg milli

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A.- Heart failure with preserved or moderately reduced ejection fraction (HFp / HFmr) that meet diagnostic criteria according to the Clinical Guidelines of the European Society of Cardiology : - At least one episode of symptoms and / or signs of heart failure in the last 6 months. - Demonstrated ejection fraction> 40% (including clinical entities of preserved and moderately reduced ejection fraction). - Elevation natriuretic peptides: NTproBNP> 125 pg / ml or BNP> 35 pg / ml - Demonstration of structural heart disease: Left ventricular hypertrophy / left atrial enlargement / diastolic dysfunction B.- Vitamin D deficiency demonstrated with serum levels =65 years) yes F.1.3.1 Number of subjects for this age range 102

Exclusion criteria

Exclusion criteria: - Active treatment with Vitamin D supplements. - Advanced chronic kidney disease with glomerular filtration 10.5 mg / dL). - Severe valvular disease of any origin. - Atrial fibrillation. - Severe psychosocial problems (dementia, alcoholism, any consumption of toxics, psychiatric disorders or moderate or severe cognitive impairment of any origin that prevent the patient's follow-up or adherence to the study).

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of Vitamin D supplementation in patients with heart failure with preserved or moderately reduced ejection fraction who have Vitamin D deficiency on the longitudinal and circumferential ventricular deformation rate (STRAIN).;Secondary Objective: - Assess differences in mortality between the treatment arm (vitamin D) and the placebo arm of the study. - Assess differences in the re-admission rate and time to first admission between the treatment arm (Vitamin D) and the placebo arm of the study. - Assess differences in the quality of life of patients between the treatment arm (vitamin D) and the placebo arm of the study. - Assess differences in baseline dyspnea of ??patients according to the NYHA classification between the treatment arm (vitamin D) and the placebo arm of the study.;Primary end point(s): Absolute change from baseline in the longitudinal deformation of the left ventricle.;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Main Objective: To evaluate the efficacy of Vitamin D supplementation in patients with heart failure with preserved or moderately reduced ejection fraction who have Vitamin D deficiency on the longitudinal and circumferential ventricular deformation rate (STRAIN).;Secondary Objective: - Assess differences in mortality between the treatment arm (vitamin D) and the placebo arm of the study. - Assess differences in the re-admission rate and time to first admission between the treatment arm (Vitamin D) and the placebo arm of the study. - Assess differences in the quality of life of patients between the treatment arm (vitamin D) and the placebo arm of the study. - Assess differences in baseline dyspnea of ??patients according to the NYHA classification between the treatment arm (vitamin D) and the placebo arm of the study.;Primary end point(s): Absolute change from baseline in the longitudinal deformation of the left ventricle.;Timepoint(s) of evaluation of this end point: 6 months

—

Secondary

Measure	Time frame
Secondary end point(s): Time to first admission.;Timepoint(s) of evaluation of this end point: 6 months	—

Countries

Spain

Contacts

Public ContactServicio de Medicina Interna

Hospital Morales Meseguer

sergio.aleman.belando@gmail.com

Outcome results

None listed

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