Beneficial effects of vitamin D combined with oral iron supplementation in patients with chronic heart failure and iron deficiency (VICTORID-HF TRIAL)

2024-519878-39-00 Protocol VICTORID_01 Therapeutic use (Phase IV) Ongoing, recruiting

Start 12 Jul 2024 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites · Protocol VICTORID_01

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ongoing, recruiting
Participants planned 258
Countries 1
Sites 1

Chronic heart failure; iron deficiency

The purpose of this study is to evaluate whether, in patients with chronic heart failure and iron deficiency, the administration of vitamin D in combination with sucrosomial iron is as effective as intravenous ferric carboxymaltose in improving symptoms of heart failure. The first aim is to test the non-inferiority of …

Key facts

Sponsor
Universita Degli Studi Di Padova
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Cardiovascular Diseases [C14]
Trial duration
12 Jul 2024 → ongoing
Decision date (initial)
2025-01-21
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
PharmaNutra Spa

External identifiers

EU CT number
2024-519878-39-00
EudraCT number
2022-004186-21
ClinicalTrials.gov
NCT05702970

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

The purpose of this study is to evaluate whether, in patients with chronic heart failure and iron deficiency, the administration of vitamin D in combination with
sucrosomial iron is as effective as intravenous ferric carboxymaltose in improving symptoms of heart failure. The first aim is to test the non-inferiority of sucrosomial iron treatment compared with the ferric carboxymaltose treatment, after 24 weeks of treatment.

Secondary objectives 1

  1. Assess quality of life (QoL), physical limitations, symptoms, and limitations in social life (QoL Endpoints); Assess the impact of vitamin D supplementation combined with sucrosomial iron on New York Heart Association (NYHA) class, relevant laboratory and echocardiographic parameters, re-hospitalizations, and mortality in patients with heart failure and iron deficiency (Cardiovascular Endpoints and General Endpoints); assess the effects of iron supplementation (either intravenous, oral, or with the addition of vitamin D) on calcium-phosphorus metabolism (Calcium-phosphorus metabolism Endpoints)

Conditions and MedDRA coding

Chronic heart failure; iron deficiency

VersionLevelCodeTermSystem organ class
20.0 PT 10007558 Cardiac failure chronic 100000004849
24.0 LLT 10060496 Hyposideremia 10027433
20.1 LLT 10064081 Heart failure NYHA class III 10007541
20.1 LLT 10064080 Heart failure NYHA class II 10007541
20.0 LLT 10019284 Heart failure congestive 10007541

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 Study design VICTORID-HF
Interventional, randomized, controlled, open-label, sequential recruitment study of outpatients, diagnosed with symptomatic chronic heart failure- HF (NYHA class II-III), left ventricle ejection fraction (LVEF) ≤45%, iron deficiency- ID (ferritin <100 ng/ml or transferrin saturation - TSAT <20% in case of ferritin levels between 100 and 300 ng/ml) and hemoglobin values (Hb) between 9.5-13.5 g/dL. In patients hospitalized for acute HF episode (inpatients), pre-randomization will be performed and re-evaluation for recruitment during outpatient visit will be scheduled at least 3 weeks after stabilization. Eligible patients will be randomized at each center to receive treatment with FCM, sucrosomial iron, or sucrosomial iron and vitamin D at a 1:1:1 ratio. Assignment to individual groups will be performed using a special online randomization tool ["Randomizer for Clinical Trials" (http://www.randomizer.at)]. Block randomization will be performed to stratify patients by gender and age. Patients and examining physicians will be aware of the allocated arm, whereas, outcome analysts will be kept blinded to the treatment allocation arm. This will be accomplished by blinding the investigators assessing: NHYA class, distance walked at 6 Min Walking Test-6MWT, clinical score and vital signs. Echocardiography data will be measured offline or by an independent physician, blinded to the treatment allocation. Events at follow-up will be assessed by an adjudication committee blinded to the treatment arm.
 Randomised Controlled None Control group: Administration of ferric carboxymaltose FCM (Ferinject®) with a dose between 500 and 2000 mg (depending on weight and Hb values), to be administered in 1 or 2 doses (time 0 ± 6 weeks) with possible further administration of 500 mg at week 12 in case of persistent iron deficiency- ID.
Sucrosomial iron group: Administration of sucrosomial iron (SiderAl Forte®) at a dose of 60 mg (2 tablets) once daily for 24 weeks.
Sucrosomial iron and vitamin D group: Administration of sucrosomial iron (SiderAl Forte®) at a dose of 60 mg (2 tablets) once daily + Vitamin D3 (100000 IU load with Dibase® 100000 IU at time 0, then 2,000 IU daily with UltraD3®) for 24 weeks

Regulatory references

Plan to share IPD
No
EU CT numberTitleSponsor
2024-514731-15-00 Beneficial effects of vitamin D combined with oral iron supplementation in patients with chronic heart failure and iron deficiency (VICTORID-HF TRIAL) Universita Degli Studi Di Padova

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

  1. Stable symptomatic chronic heart failure (NYHA functional class II-III) and all of the following: at least 3 weeks since the last hospitalization or emergency department access for acute HF, optimal drug treatment for heart failure (HF) according to the ESC guidelines determined by the investigator (unless contraindications or treatment not tolerated), no changes in HF therapy dose in the previous 2 weeks (except diuretics), no new HF therapy in the 3 weeks prior to recruitment, left ventricle ejection fraction <=45% , brain natriuretic peptide >100 pg/mL and/or N-terminal-pro-brain natriuretic peptide >400 pg/mL at pre-recruitment evaluation, evidence of iron deficiency defined as ferritin <100 ng/ml or TSAT <20% in the case of ferritin levels between 100 and 300 ng/ml, vitamin D levels <50 nmol/L, the subject must be able to complete the 6-Minute-Walking -Test, at least 18 years of age.

Exclusion criteria 1

  1. Myocardial infarction or acute coronary syndrome, transient ischemic attack or stroke, coronary artery bypass, percutaneous intervention, or major thoracic or cardiac surgery within the previous 2 months; clinically relevant (severe) non-corrected valvular heart disease, obstructive cardiomyopathy; chronic anemia due to non-correctable causes other than iron deficiency and anemia of chronic disease (e.g., hemoglobinopathies, hematologic malignancies, hemolytic anemia); anemia due to vitamin B12 or acid folic deficiency (recruitment may be re-evaluated at least 6 weeks after the end of vitamin B12 and or folic acid supplementation); history of acquired iron overload; administration of erythropoietin, iron supplementation (either oral or intravenous iron), blood transfusion in the previous 6 weeks or already scheduled for 3 months after recruitment; administration of vitamin D or similar in the 3 months preceding or already scheduled for the 3 months following recruitment; severe bone disease; active infections (C-reactive protein >20 mg/L); clinically significant bleeding; active neoplasm (with exception of basal cell or squamous cell carcinoma of the skin and intraepithelial cervical neoplasia); chronic liver disease (including active hepatitis) and/or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x normal limit; immunosuppressive therapy or dialysis; pregnancy or breastfeeding; the subject has a known sensitivity to any of the products that will be administered during the study protocol.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The performance of the Six-Minute Walking Test (6MWT), comparing the mean difference from baseline of the distance walked by patients in meters.

Secondary endpoints 1

  1. Assess in the tree-arms treatment during the study the change in Kansas City Cardiomyopathy Questionnaire(KCCQ) score, NYHA class, echocardiographic parameters (parameters of systolic and diastolic function, parietal thicknesses, and left ventricular diameters), calcium and phosphorus profile (levels of calcium, phosphate and human Fibroblast Growth Factors), incidence of fractures, glomerular filtration rate, surviving days out of hospital, hospitalizations and mortality

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

-

B03AB · Product

Pharmaceutical form
PHF00006MIG
Route of administration
ORAL
Max daily dose
60 mg milligram(s)
Max total dose
60 mg milligram(s)
Max treatment duration
24 Week(s)
Authorisation status
Authorised
ATC code
B03AB — IRON TRIVALENT, ORAL PREPARATIONS
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

-

A11CC · Product

Pharmaceutical form
PHF00007MIG
Route of administration
ORAL
Max daily dose
50 µg microgram(s)
Max total dose
50 µg microgram(s)
Max treatment duration
24 Week(s)
Authorisation status
Authorised
ATC code
A11CC — VITAMIN D AND ANALOGUES
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

DIBASE 100.000 U.I./ml soluzione iniettabile

PRD386129 · Product

Active substance
Colecalciferol
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
ORAL
Max daily dose
100000 U unit(s)
Max total dose
100000 U unit(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
A11CC05 — COLECALCIFEROL
Marketing authorisation
036635023
MA holder
ABIOGEN PHARMA S.P.A.
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Comparator 1

Ferinject 50 mg ferro/mL dispersione iniettabile/per infusione.

PRD469699 · Product

Active substance
Ferric Carboxymaltose
Substance synonyms
VIT-45
Pharmaceutical form
DISPERSION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS INJECTION
Max daily dose
1500 mg milligram(s)
Max total dose
2500 mg milligram(s)
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
B03AC — IRON TRIVALENT, PARENTERAL PREPARATIONS
Marketing authorisation
040251035
MA holder
VIFOR FRANCE
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universita Degli Studi Di Padova

3 Total trials 2 Recruiting 1 Ended
Academic / Non-commercial
Sponsor organisation
Universita Degli Studi Di Padova
Address
Via Nicolo' Giustiniani 2
City
Padova
Postcode
35128
Country
Italy

Scientific contact point

Organisation
Universita Degli Studi Di Padova
Contact name
Federico Capone

Public contact point

Organisation
Universita Degli Studi Di Padova
Contact name
Federico Capone

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Italy Ongoing, recruiting 258 1
Rest of world — 0 —

Investigational sites

Italy

1 site · Ongoing, recruiting
Azienda Ospedaliera di Padova
DIMED, Via Nicolo' Giustiniani 2, 35128, Padova

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Italy 2024-07-12 2024-09-23

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) Study protocol_VICTORID-HF 1
Recruitment arrangements (for publication) Placeholder document_VICTORID 1
Subject information and informed consent form (for publication) ICF_vers 1_5_11_11_24 1
Summary of Product Characteristics (SmPC) (for publication) Dibase_RCP 1
Summary of Product Characteristics (SmPC) (for publication) FERINJECT_RCP 1
Summary of Product Characteristics (SmPC) (for publication) Sideral forte_RCP 1
Summary of Product Characteristics (SmPC) (for publication) Ultra D3_RCP 1
Synopsis of the protocol (for publication) Study Sinossi_VICTORID-HF 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-11-26 Italy Acceptable
2025-01-08
 2025-01-21

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