AnemiaPhase 4SideralDoseNCT07038330
DOSE FINDING PROSPECTIVE ANALYSIS AFTER HEART SURGERY for Sucrosomial Iron
A Phase 4 study testing Sucrosomial Iron in people with Anemia, run by Cardiochirurgia E.H..
Trial summary
Randomization to different doses of Sucrosomial Iron for one moth after discharge to rehab after heart surgery to assess if more iron grants a faster recovery or not Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anemia
- What is being tested?
- Sucrosomial Iron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 23 Jun 2025to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Hb>11.1, hematological primary disesases
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: POSTOPERATIVE SUCROSOMIAL IRON IN HEART SURGERY: DOSE FINDING PROSPECTIVE STUDY (SideralDose)
Randomization to different doses of Sucrosomial Iron for one moth after discharge to rehab after heart surgery to assess if more iron grants a faster recovery or not
Read the detailed description
Evaluation of the efficacy of short-term sucrosomial iron treatment in patients undergoing cardiac surgery and subsequently transferred to rehabilitation, measured in terms of increase in hemoglobin values and restoration of martial blood parameters, administering doses of 30mg, 60mg and 120mg respectively, after randomization of patients.
Numerical congruity analysis, power sampling, biometric characteristics of internal compatibility between cohorts and outcome analysis with comparison for continuous homoscedastic case-control variables
Drafting of formal statistical analysis, drafting of information synopsis, writing, validation, forwarding to scientific journal and correction until obtaining, where possible, publications of the manuscript relating to the research.
- Conditions
- Anemia
- Being tested
- Sucrosomial Iron
- Keywords
- Sucrosomial Iron, Oral Iron, Post Cardiac Surgery Rehabilitation
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sucrosomial IronDrug
Sideral Forte, Italian market formulation of Sucrosomila Iron 30mg per cp
| Study group | Role | What they receive |
|---|---|---|
| 30mg | Experimental | 1 cp (30mg) per day of Sucrosomial Iron Receives: Drug: Sucrosomial Iron |
| 60mg | Experimental | 2 cp (60mg) per day of Sucrosomial Iron Receives: Drug: Sucrosomial Iron |
| 120mg | Experimental | 4 cp (120mg) per day of Sucrosomial Iron Receives: Drug: Sucrosomial Iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin
Hemoglobin level at 30 day of treatment
Measured: 30 days
Secondary outcomes (1)
Martial Metabolism
Ferritin, Transferrin, Iron Saturation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start23 Jun 2025 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1:1 randomization, one month administration,. two months follow up
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiochirurgia E.H.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Paolo P Weltert, MD, Principal investigator, European Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038330
- Sponsor's protocol ID
- SideralDose
- Acronym
- SideralDose
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Pierelli L, De Rosa A, Falco M, Papi E, Rondinelli MB, Turani F, Weltert L. Preoperative Sucrosomial Iron Supplementation Increases Haemoglobin and Reduces Transfusion Requirements in Elective Heart Surgery Patients: A Prospective Randomized Study. Surg Technol Int. 2021 Oct 28;39:321-328. doi: 10.52198/21.STI.39.CV1512.
PubMed 34710946Venturini E, Iannuzzo G, DI Lorenzo A, Cuomo G, D'Angelo A, Merone P, Cudemo G, Pacileo M, D'Andrea A, Vigorito C, Giallauria F. Short-term treatment of iron deficiency anemia after cardiac surgery. Int J Cardiol Heart Vasc. 2022 May 2;40:101038. doi: 10.1016/j.ijcha.2022.101038. eCollection 2022 Jun.
PubMed 35514874Weltert LP, De Rosa A, Rondinelli MB, Falco M, Turani F, Pierelli L. Benefits of pre-operative oral Sucrosomial(R) iron supplementation in cardiac surgery: influence of patient's baseline hemoglobin and gender. Blood Transfus. 2023 Jul;21(4):305-313. doi: 10.2450/2022.0222-22. Epub 2022 Nov 25.
PubMed 36580029
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POSTOPERATIVE SUCROSOMIAL IRON IN HEART SURGERY: DOSE FINDING PROSPECTIVE STUDY (SideralDose)
- ClinicalTrials.gov ID
- NCT07038330
- Acronym / sponsor ID
- SideralDose / SideralDose
- Conditions
- Anemia
- Keywords
- Sucrosomial Iron, Oral Iron, Post Cardiac Surgery Rehabilitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cardiochirurgia E.H.University, hospital or other
- Study start
- 23 Jun 2025 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomization to different doses of Sucrosomial Iron for one moth after discharge to rehab after heart surgery to assess if more iron grants a faster recovery or not
Detailed description
Evaluation of the efficacy of short-term sucrosomial iron treatment in patients undergoing cardiac surgery and subsequently transferred to rehabilitation, measured in terms of increase in hemoglobin values and restoration of martial blood parameters, administering doses of 30mg, 60mg and 120mg respectively, after randomization of patients.
Numerical congruity analysis, power sampling, biometric characteristics of internal compatibility between cohorts and outcome analysis with comparison for continuous homoscedastic case-control variables
Drafting of formal statistical analysis, drafting of information synopsis, writing, validation, forwarding to scientific journal and correction until obtaining, where possible, publications of the manuscript relating to the research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 1:1:1 randomization, one month administration,. two months follow up
| Arm | Type | Receives |
|---|---|---|
| 30mg | Experimental | Drug: Sucrosomial Iron1 cp (30mg) per day of Sucrosomial Iron |
| 60mg | Experimental | Drug: Sucrosomial Iron2 cp (60mg) per day of Sucrosomial Iron |
| 120mg | Experimental | Drug: Sucrosomial Iron4 cp (120mg) per day of Sucrosomial Iron |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Hb>11.1, hematological primary disesases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sucrosomial IronSideral Forte, Italian market formulation of Sucrosomila Iron 30mg per cp | Drug | 120mg, 30mg, 60mg |
Primary outcome
Hemoglobin
Time frame: 30 days
Hemoglobin level at 30 day of treatment
1 secondary outcome
Martial Metabolism
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Results publication: PubMed 34710946Pierelli L, De Rosa A, Falco M, Papi E, Rondinelli MB, Turani F, Weltert L. Preoperative Sucrosomial Iron Supplementation Increases Haemoglobin and Reduces Transfusion Requirements in Elective Heart Surgery Patients: A Prospective Randomized Study. Surg Technol Int. 2021 Oct 28;39:321-328. doi: 10.52198/21.STI.39.CV1512.
- Results publication: PubMed 35514874Venturini E, Iannuzzo G, DI Lorenzo A, Cuomo G, D'Angelo A, Merone P, Cudemo G, Pacileo M, D'Andrea A, Vigorito C, Giallauria F. Short-term treatment of iron deficiency anemia after cardiac surgery. Int J Cardiol Heart Vasc. 2022 May 2;40:101038. doi: 10.1016/j.ijcha.2022.101038. eCollection 2022 Jun.
- Results publication: PubMed 36580029Weltert LP, De Rosa A, Rondinelli MB, Falco M, Turani F, Pierelli L. Benefits of pre-operative oral Sucrosomial(R) iron supplementation in cardiac surgery: influence of patient's baseline hemoglobin and gender. Blood Transfus. 2023 Jul;21(4):305-313. doi: 10.2450/2022.0222-22. Epub 2022 Nov 25.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luca Paolo P Weltert, MD principal investigator
European Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sucrosomial Iron in people with Anemia, run by Cardiochirurgia E.H..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luca P Weltert, MD (+393478880617, lweltert@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07038330, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.