Aortic StenosisPhase 4INERTIANCT04786769

Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency

A Phase 4 study testing Ferric carboxymaltose in people with Aortic Stenosis and Iron-deficiency, run by Hospital de Santa Cruz, Portugal.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

The INERTIA trial is a multicenter double-blinded randomized trial of intravenous iron supplementation in patients with severe aortic stenosis and iron deficiency undergoing TAVI or SAVR. The primary endpoint is the time to HF hospital admission or cardiovascular death. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Aortic Stenosis, Iron-deficiency
What is being tested?: Ferric carboxymaltose
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2,500 participants
Where: No sites listed yet
Study dates: Jan 2022to Jun 2025
Phase: Phase 4
Are there results?: None posted in the registry

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 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Severe aortic stenosis
Enrolled for TAVI or SAVR procedures
Documented iron deficiency with either: Ferritin <100ug/L or Ferritin between 100-299ug/L and Transferrin Saturation < 20%.

Who cannot join

Use of packed red blood cells or whole blood in the past 3 months;
Use of erythropoietin-stimulating agent or IV iron in the past 3 months;
Use of oral or IV iron (>100mg/day) in the past 3 months;
Haemoglobin (Hb) levels > 15g/dL or < 8g/dL;
Active cancer;
Infection requiring antibiotic treatment at the time of first scheduled dose;
Any known contraindication to study intervention

Trial locations and contacts

No sites are listed yet.

Afonso Félix-Oliveira, MSc contact

00351210433001

afonso.felix.oliveira@gmail.com

About this study

Official title: A Randomized Clinical Trial of Intravenous Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency

Conditions: Aortic Stenosis, Iron-deficiency
Being tested: Ferric carboxymaltose
Medical subject headings: Aortic Valve Stenosis, Anemia, Iron-Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ferric carboxymaltoseDrug
Intravenous ferric carboxymaltose according to baseline weight and hemoglobin

Study groups in NCT04786769
Study group	Role	What they receive
Iron supplementation	Experimental	Intravenous ferric carboxymaltose will be administered according to weight and hemoglobin values at randomization as follows: 2-4 weeks before valve intervention On the day of admission to valve intervention (if determined by dose calculation, otherwise placebo) 12 weeks after valve intervention (if iron deficiency persists, otherwise placebo) Receives: Drug: Ferric carboxymaltose
Placebo	Placebo comparator	Intravenous 0.9% NaCl (placebo) will be administered as follows: 2-4 weeks before valve intervention On the day of admission to valve intervention 12 weeks after valve intervention Receives: Drug: Ferric carboxymaltose

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of patients with heart failure hospital admission or cardiovascular death
Analyzed as time-to-event
Measured: up to 52 weeks

Secondary outcomes (5)

Total number of allogeneic RBC units received
Measured: 30 days post-TAVI or SAVR
Walking distance
6 minute walking test
Measured: 6 months post-TAVI or SAVR
Kansas City Cardiomyopathy Questionnaire
Heart failure symptoms assessment. 0-100 scale, higher scores reflect better health status.
Measured: 6 months post-TAVI or SAVR
Patient Global Assessment
Patient reported outcome on the impact of the disease in daily live
Measured: 6 months post-TAVI or SAVR
EQ-5D-5L
Quality of life assessment in five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Measured: 6 months post-TAVI or SAVR

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2022Jun 2025

First posted8 Mar 2021
Study startJan 2022 (estimated)
Primary completionJan 2025 (estimated)
Study completionJun 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Aortic StenosisStudies 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: Two-arm trial of intravenous iron supplementation vs placebo, randomized 1:1.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 2,500 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04786769
Sponsor's protocol ID: UNICARV-1
Acronym: INERTIA
Status last verified: Mar 2021
First submitted: 2 Mar 2021
Last updated: 8 Mar 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Carroll JD, Mack MJ, Vemulapalli S, Herrmann HC, Gleason TG, Hanzel G, Deeb GM, Thourani VH, Cohen DJ, Desai N, Kirtane AJ, Fitzgerald S, Michaels J, Krohn C, Masoudi FA, Brindis RG, Bavaria JE. STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2020 Nov 24;76(21):2492-2516. doi: 10.1016/j.jacc.2020.09.595.
PubMed 33213729
Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG; PARTNER 2 Investigators. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016 Apr 28;374(17):1609-20. doi: 10.1056/NEJMoa1514616. Epub 2016 Apr 2.
PubMed 27040324
Vemulapalli S, Dai D, Hammill BG, Baron SJ, Cohen DJ, Mack MJ, Holmes DR Jr. Hospital Resource Utilization Before and After Transcatheter Aortic Valve Replacement: The STS/ACC TVT Registry. J Am Coll Cardiol. 2019 Mar 19;73(10):1135-1146. doi: 10.1016/j.jacc.2018.12.049.
PubMed 30871697
Myles PS, Richards T, Klein A. Preoperative intravenous iron for cardiac surgery. Lancet. 2020 Dec 12;396(10266):1883-1884. doi: 10.1016/S0140-6736(20)32406-5. No abstract available.
PubMed 33308468
Abdul-Jawad Altisent O, Puri R, Regueiro A, Chamandi C, Rodriguez-Gabella T, Del Trigo M, Campelo-Parada F, Couture T, Marsal JR, Cote M, Paradis JM, DeLarochelliere R, Doyle D, Mohammadi S, Dumont E, Rodes-Cabau J. Predictors and Association With Clinical Outcomes of the Changes in Exercise Capacity After Transcatheter Aortic Valve Replacement. Circulation. 2017 Aug 15;136(7):632-643. doi: 10.1161/CIRCULATIONAHA.116.026349. Epub 2017 Jun 6.
PubMed 28588077
Zimarino M, Barbanti M, Dangas GD, Testa L, Capodanno D, Stefanini GG, Radico F, Marchioni M, Amat-Santos I, Piva T, Saia F, Reimers B, De Innocentiis C, Picchi A, Toro A, Rodriguez-Gabella T, Nicolini E, Moretti C, Gallina S, Maddestra N, Bedogni F, Tamburino C. Early Adverse Impact of Transfusion After Transcatheter Aortic Valve Replacement: A Propensity-Matched Comparison From the TRITAVI Registry. Circ Cardiovasc Interv. 2020 Dec;13(12):e009026. doi: 10.1161/CIRCINTERVENTIONS.120.009026. Epub 2020 Dec 4.
PubMed 33272037
Costa F, Cohen MG. Transfusion and Mortality After Transcatheter Aortic Valve Replacement: Association or Causation? Circ Cardiovasc Interv. 2020 Dec;13(12):e010225. doi: 10.1161/CIRCINTERVENTIONS.120.010225. Epub 2020 Dec 4. No abstract available.
PubMed 33272032
Nuis RJ, Rodes-Cabau J, Sinning JM, van Garsse L, Kefer J, Bosmans J, Dager AE, van Mieghem N, Urena M, Nickenig G, Werner N, Maessen J, Astarci P, Perez S, Benitez LM, Dumont E, van Domburg RT, de Jaegere PP. Blood transfusion and the risk of acute kidney injury after transcatheter aortic valve implantation. Circ Cardiovasc Interv. 2012 Oct;5(5):680-8. doi: 10.1161/CIRCINTERVENTIONS.112.971291. Epub 2012 Oct 9.
PubMed 23048055
Klein AA, Chau M, Yeates JA, Collier T, Evans C, Agarwal S, Richards T; UK Cardiac and Vascular Surgery Interventional Anaemia Response (CAVIAR) study team. Preoperative intravenous iron before cardiac surgery: a prospective multicentre feasibility study. Br J Anaesth. 2020 Mar;124(3):243-250. doi: 10.1016/j.bja.2019.11.023. Epub 2020 Jan 3.
PubMed 31902590
Anker SD, Comin Colet J, Filippatos G, Willenheimer R, Dickstein K, Drexler H, Luscher TF, Bart B, Banasiak W, Niegowska J, Kirwan BA, Mori C, von Eisenhart Rothe B, Pocock SJ, Poole-Wilson PA, Ponikowski P; FAIR-HF Trial Investigators. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med. 2009 Dec 17;361(25):2436-48. doi: 10.1056/NEJMoa0908355. Epub 2009 Nov 17.
PubMed 19920054
Ponikowski P, van Veldhuisen DJ, Comin-Colet J, Ertl G, Komajda M, Mareev V, McDonagh T, Parkhomenko A, Tavazzi L, Levesque V, Mori C, Roubert B, Filippatos G, Ruschitzka F, Anker SD; CONFIRM-HF Investigators. Beneficial effects of long-term intravenous iron therapy with ferric carboxymaltose in patients with symptomatic heart failure and iron deficiencydagger. Eur Heart J. 2015 Mar 14;36(11):657-68. doi: 10.1093/eurheartj/ehu385. Epub 2014 Aug 31.
PubMed 25176939
Jankowska EA, Tkaczyszyn M, Suchocki T, Drozd M, von Haehling S, Doehner W, Banasiak W, Filippatos G, Anker SD, Ponikowski P. Effects of intravenous iron therapy in iron-deficient patients with systolic heart failure: a meta-analysis of randomized controlled trials. Eur J Heart Fail. 2016 Jul;18(7):786-95. doi: 10.1002/ejhf.473. Epub 2016 Jan 28.
PubMed 26821594
Ponikowski P, Kirwan BA, Anker SD, Dorobantu M, Drozdz J, Fabien V, Filippatos G, Haboubi T, Keren A, Khintibidze I, Kragten H, Martinez FA, McDonagh T, Metra M, Milicic D, Nicolau JC, Ohlsson M, Parhomenko A, Pascual-Figal DA, Ruschitzka F, Sim D, Skouri H, van der Meer P, Jankowska EA. Rationale and design of the AFFIRM-AHF trial: a randomised, double-blind, placebo-controlled trial comparing the effect of intravenous ferric carboxymaltose on hospitalisations and mortality in iron-deficient patients admitted for acute heart failure. Eur J Heart Fail. 2019 Dec;21(12):1651-1658. doi: 10.1002/ejhf.1710. Epub 2019 Dec 28.
PubMed 31883356
Ponikowski P, Kirwan BA, Anker SD, McDonagh T, Dorobantu M, Drozdz J, Fabien V, Filippatos G, Gohring UM, Keren A, Khintibidze I, Kragten H, Martinez FA, Metra M, Milicic D, Nicolau JC, Ohlsson M, Parkhomenko A, Pascual-Figal DA, Ruschitzka F, Sim D, Skouri H, van der Meer P, Lewis BS, Comin-Colet J, von Haehling S, Cohen-Solal A, Danchin N, Doehner W, Dargie HJ, Motro M, Butler J, Friede T, Jensen KH, Pocock S, Jankowska EA; AFFIRM-AHF investigators. Ferric carboxymaltose for iron deficiency at discharge after acute heart failure: a multicentre, double-blind, randomised, controlled trial. Lancet. 2020 Dec 12;396(10266):1895-1904. doi: 10.1016/S0140-6736(20)32339-4. Epub 2020 Nov 13.
PubMed 33197395
Richards T, Baikady RR, Clevenger B, Butcher A, Abeysiri S, Chau M, Macdougall IC, Murphy G, Swinson R, Collier T, Van Dyck L, Browne J, Bradbury A, Dodd M, Evans R, Brealey D, Anker SD, Klein A. Preoperative intravenous iron to treat anaemia before major abdominal surgery (PREVENTT): a randomised, double-blind, controlled trial. Lancet. 2020 Oct 24;396(10259):1353-1361. doi: 10.1016/S0140-6736(20)31539-7. Epub 2020 Sep 5.
PubMed 32896294

Want to know more?

Afonso Félix-Oliveira, MSc

00351210433001

afonso.felix.oliveira@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Aortic Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Clinical Trial of Intravenous Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency
ClinicalTrials.gov ID: NCT04786769
Acronym / sponsor ID: INERTIA / UNICARV-1
Conditions: Aortic Stenosis, Iron-deficiency
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 2,500 participants (estimated)
Lead sponsor: Hospital de Santa Cruz, PortugalUniversity, hospital or other
Study start: Jan 2022 (estimated)
Primary completion: Jan 2025 (estimated)
Study completion: Jun 2025 (estimated)
First posted: 8 Mar 2021 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Two-arm trial of intravenous iron supplementation vs placebo, randomized 1:1.

Arm	Type	Receives
Iron supplementation	Experimental	Drug: Ferric carboxymaltoseIntravenous ferric carboxymaltose will be administered according to weight and hemoglobin values at randomization as follows: 2-4 weeks before valve intervention On the day of admission to valve intervention (if determined by dose calculation, otherwise placebo) 12 weeks after valve intervention (if iron deficiency persists, otherwise placebo)
Placebo	Placebo comparator	Drug: Ferric carboxymaltoseIntravenous 0.9% NaCl (placebo) will be administered as follows: 2-4 weeks before valve intervention On the day of admission to valve intervention 12 weeks after valve intervention

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Severe aortic stenosis
Enrolled for TAVI or SAVR procedures
Documented iron deficiency with either: Ferritin <100ug/L or Ferritin between 100-299ug/L and Transferrin Saturation < 20%.

Key exclusion criteria (7 listed)

Use of packed red blood cells or whole blood in the past 3 months;
Use of erythropoietin-stimulating agent or IV iron in the past 3 months;
Use of oral or IV iron (>100mg/day) in the past 3 months;
Haemoglobin (Hb) levels > 15g/dL or < 8g/dL;
Active cancer;

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
Ferric carboxymaltoseIntravenous ferric carboxymaltose according to baseline weight and hemoglobin	Drug	Iron supplementation, Placebo

Primary outcome

Number of patients with heart failure hospital admission or cardiovascular death
Time frame: up to 52 weeks
Analyzed as time-to-event

5 secondary outcomes

Total number of allogeneic RBC units received
Time frame: 30 days post-TAVI or SAVR
Walking distance
Time frame: 6 months post-TAVI or SAVR
Kansas City Cardiomyopathy Questionnaire
Time frame: 6 months post-TAVI or SAVR
Patient Global Assessment
Time frame: 6 months post-TAVI or SAVR
EQ-5D-5L
Time frame: 6 months post-TAVI or SAVR

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
Background: PubMed 33213729Carroll JD, Mack MJ, Vemulapalli S, Herrmann HC, Gleason TG, Hanzel G, Deeb GM, Thourani VH, Cohen DJ, Desai N, Kirtane AJ, Fitzgerald S, Michaels J, Krohn C, Masoudi FA, Brindis RG, Bavaria JE. STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2020 Nov 24;76(21):2492-2516. doi: 10.1016/j.jacc.2020.09.595.
Background: PubMed 27040324Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG; PARTNER 2 Investigators. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016 Apr 28;374(17):1609-20. doi: 10.1056/NEJMoa1514616. Epub 2016 Apr 2.
Background: PubMed 30871697Vemulapalli S, Dai D, Hammill BG, Baron SJ, Cohen DJ, Mack MJ, Holmes DR Jr. Hospital Resource Utilization Before and After Transcatheter Aortic Valve Replacement: The STS/ACC TVT Registry. J Am Coll Cardiol. 2019 Mar 19;73(10):1135-1146. doi: 10.1016/j.jacc.2018.12.049.
Background: PubMed 33308468Myles PS, Richards T, Klein A. Preoperative intravenous iron for cardiac surgery. Lancet. 2020 Dec 12;396(10266):1883-1884. doi: 10.1016/S0140-6736(20)32406-5. No abstract available.
Background: PubMed 28588077Abdul-Jawad Altisent O, Puri R, Regueiro A, Chamandi C, Rodriguez-Gabella T, Del Trigo M, Campelo-Parada F, Couture T, Marsal JR, Cote M, Paradis JM, DeLarochelliere R, Doyle D, Mohammadi S, Dumont E, Rodes-Cabau J. Predictors and Association With Clinical Outcomes of the Changes in Exercise Capacity After Transcatheter Aortic Valve Replacement. Circulation. 2017 Aug 15;136(7):632-643. doi: 10.1161/CIRCULATIONAHA.116.026349. Epub 2017 Jun 6.
Background: PubMed 33272037Zimarino M, Barbanti M, Dangas GD, Testa L, Capodanno D, Stefanini GG, Radico F, Marchioni M, Amat-Santos I, Piva T, Saia F, Reimers B, De Innocentiis C, Picchi A, Toro A, Rodriguez-Gabella T, Nicolini E, Moretti C, Gallina S, Maddestra N, Bedogni F, Tamburino C. Early Adverse Impact of Transfusion After Transcatheter Aortic Valve Replacement: A Propensity-Matched Comparison From the TRITAVI Registry. Circ Cardiovasc Interv. 2020 Dec;13(12):e009026. doi: 10.1161/CIRCINTERVENTIONS.120.009026. Epub 2020 Dec 4.
Background: PubMed 33272032Costa F, Cohen MG. Transfusion and Mortality After Transcatheter Aortic Valve Replacement: Association or Causation? Circ Cardiovasc Interv. 2020 Dec;13(12):e010225. doi: 10.1161/CIRCINTERVENTIONS.120.010225. Epub 2020 Dec 4. No abstract available.
Background: PubMed 23048055Nuis RJ, Rodes-Cabau J, Sinning JM, van Garsse L, Kefer J, Bosmans J, Dager AE, van Mieghem N, Urena M, Nickenig G, Werner N, Maessen J, Astarci P, Perez S, Benitez LM, Dumont E, van Domburg RT, de Jaegere PP. Blood transfusion and the risk of acute kidney injury after transcatheter aortic valve implantation. Circ Cardiovasc Interv. 2012 Oct;5(5):680-8. doi: 10.1161/CIRCINTERVENTIONS.112.971291. Epub 2012 Oct 9.
Background: PubMed 31902590Klein AA, Chau M, Yeates JA, Collier T, Evans C, Agarwal S, Richards T; UK Cardiac and Vascular Surgery Interventional Anaemia Response (CAVIAR) study team. Preoperative intravenous iron before cardiac surgery: a prospective multicentre feasibility study. Br J Anaesth. 2020 Mar;124(3):243-250. doi: 10.1016/j.bja.2019.11.023. Epub 2020 Jan 3.
Background: PubMed 19920054Anker SD, Comin Colet J, Filippatos G, Willenheimer R, Dickstein K, Drexler H, Luscher TF, Bart B, Banasiak W, Niegowska J, Kirwan BA, Mori C, von Eisenhart Rothe B, Pocock SJ, Poole-Wilson PA, Ponikowski P; FAIR-HF Trial Investigators. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med. 2009 Dec 17;361(25):2436-48. doi: 10.1056/NEJMoa0908355. Epub 2009 Nov 17.
Background: PubMed 25176939Ponikowski P, van Veldhuisen DJ, Comin-Colet J, Ertl G, Komajda M, Mareev V, McDonagh T, Parkhomenko A, Tavazzi L, Levesque V, Mori C, Roubert B, Filippatos G, Ruschitzka F, Anker SD; CONFIRM-HF Investigators. Beneficial effects of long-term intravenous iron therapy with ferric carboxymaltose in patients with symptomatic heart failure and iron deficiencydagger. Eur Heart J. 2015 Mar 14;36(11):657-68. doi: 10.1093/eurheartj/ehu385. Epub 2014 Aug 31.
Background: PubMed 26821594Jankowska EA, Tkaczyszyn M, Suchocki T, Drozd M, von Haehling S, Doehner W, Banasiak W, Filippatos G, Anker SD, Ponikowski P. Effects of intravenous iron therapy in iron-deficient patients with systolic heart failure: a meta-analysis of randomized controlled trials. Eur J Heart Fail. 2016 Jul;18(7):786-95. doi: 10.1002/ejhf.473. Epub 2016 Jan 28.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Afonso Félix-Oliveira, MSc contact

00351210433001

afonso.felix.oliveira@gmail.com

Afonso Félix-Oliveira, MSc principal investigator

Hospital de Santa Cruz, Portugal

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ferric carboxymaltose in people with Aortic Stenosis and Iron-deficiency, run by Hospital de Santa Cruz, Portugal.

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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Mar 2021. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Afonso Félix-Oliveira, MSc (00351210433001, afonso.felix.oliveira@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with heart failure hospital admission or cardiovascular death (time frame: up to 52 weeks). 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 NCT04786769, which also lists 18 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 8 Mar 2021.