IV Sodium Ferric Gluconate Complex in Patients Undergoing TAVI

NCT04797832 | Unknown Phase 4

• 1 other identifier: 0438-20 RMB
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Iron deficiency is common among patients undergoing TAVI. It is estimated at 54-79%. Previous non-randomized small trial have shown symptomatic benefit in treating iron deficiency in this group of patients. The investigators predict, that as IV iron will improve symptoms, quality of life and exercise tolerance in this group of patients.

Conditions

Iron Deficiency Anemia Due to Blood Loss; Aortic Stenosis

Outcome Measures

Primary Outcomes (2)

• 6-minute walk change at 1 month.

  6-minute walk change (meters) between baseline and 1 month follow-up.

  30 days.

• 6-minute walk change at one year.

  6-minute walk change (meters) between baseline and 1 year follow-up.

  One year.

Study Arms (2)

Treatment

ACTIVE COMPARATOR

100 patients receiving IV Iron during index hospitalisation.

Drug: IV Sodium Ferric Gluconate Complex

No treatment

NO INTERVENTION

100 patients not receiving IV Iron above standout treatment.

Interventions

IV Sodium Ferric Gluconate Complex DRUG

125 mg of IV Iron per day to 3 to 5 days according to hospitalisation length.

Also known as: IV Ferrlecit

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted for TAVI.
• Hb level 8-14 mg/dl on admission.
• No evidence of active bleeding.
• Patient provided informed consent.
• The patient is able to walk without support for 6 minutes.
• LVEF \>= 45%

You may not qualify if:

• Previous allergy or anaphylaxis due to IV Iron.
• Active malignancy undergoing treatment.
• Status post major surgery involving substantial blood loss in the past 3 months.
• Infection indicating IV antibiotics, not including prophylaxis for TAVI.
• History of acquired iron overload; known haemochromatosis or first relatives with hemochromatosis; and allergic disorders (asthma, eczema, and anaphylactic reactions).
• Hemolytic anemia.
• History of chronic liver disease and/or alanine transaminase (ALT) or aspartate transaminase (AST) \>3 times the upper limit of the normal range; chronic lung disease; myelodysplastic disorder; and known HIV/AIDS disease.
• Recipient of immunosuppressive therapy or renal dialysis. History of erythropoietin, IV iron therapy, and blood transfusion in previous 30 days.
• Musculoskeletal limitation that, in the judgement of the investigator, would impair 6-minute walk.
• Pregnant or breastfeeding.
• Inability to comprehend study protocol.
• Parallel participation in another clinical trial.
• During TAVI or the day following the procedure:
• I. Major complication of death. II. Cardiogenic shock or any other condition requiring IV vasopressors. III. Major bleeding according to BARC 2 criteria or above. IV. Need for more than 2 pack cells during or after the procedure.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Medical Center

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

ferric gluconate

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Erez Marcusohn, MD

  Cardiology Department, Rambam Health Care Campus,Haifa,Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erez Marcusohn, MD

CONTACT

97247772180; e_marcusohn@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor is blinded to whether the patient received IV Iron.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Single blinded randomized control trial.

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 15, 2021
• Study Start: October 18, 2020
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)