Aortic Stenosis (Treated With TAVI)Phase 4NCT04346004
Effect of Preoperative Iron Isomaltoside 1000 Administration on Hemoglobin Concentration in Patients Undergoing Transcatheter Aortic Valve Implantation
A Phase 4 study testing Normal saline and Iron isomaltoside in people with Aortic Stenosis (Treated With TAVI), run by Yonsei University at 1 site in South Korea.
Trial summary
Transcatheter aortic valve implantation (TAVI) is a standard procedure for severe aortic stenosis patients with moderate or higher risk of surgery. Several studies have reported the adverse effects of blood disorders, such as anemia and iron deficiency, on the prognosis of patients undergoing TAVI, and many other… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aortic Stenosis (Treated With TAVI)
- What is being tested?
- Normal saline and Iron isomaltoside
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Apr 2020to Mar 2023
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 60 years and undergoing transcatheter aortic valve implantation (TAVI)
Who cannot join
- Emergency operation
- Cardiogenic shock or ventricular-assist device (eg. ECMO, IABP)
- Infectious condition
- Active bleeding
- Hypokalemia
- Severe chronic kidney disease (GFR(CKD-EPI) <30mL/min/1.73m2) or Dialysis
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- Patients taking erythropoietin
- Aplastic anemia, Hemolytic anemia
- Hemochromatosis, Hemosiderosis
- Uncompensated liver cirrhosis, Acute hepatitis, Alcoholism
- Peptic / Duodenal ulcer, Crohn's disease, Ulcerative colitis
- Allergy to iron supplements or vitamin B12
- Symptomatic asthma, eczema
- Immunologic disease (e.g. Rheumatoid arthritis, Systemic lupus erythematosus)
- Malignancy
- Patients being treated in the intensive care unit due to heart failure or other major complications
- Patients who participated in other clinical studies that could affect prognosis
- Patients who cannot understand the informed consent (eg. Foreigner)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul
Jong Wook Song, 82-2-2224-3971, SJW72331@yuhs.ac
About this study
Official title: Effect of Preoperative Iron Isomaltoside 1000 Administration on Hemoglobin Concentration in Patients Undergoing Transcatheter Aortic Valve Implantation: a Randomized Clinical Trial
Transcatheter aortic valve implantation (TAVI) is a standard procedure for severe aortic stenosis patients with moderate or higher risk of surgery. Several studies have reported the adverse effects of blood disorders, such as anemia and iron deficiency, on the prognosis of patients undergoing TAVI, and many other studies have been conducted to find ways to prevent them.
Iron isomaltoside, the latest intravenous iron supplement, can effectively replenish iron store with a single high-dose injection. Research has shown that a preoperative single high-dose iron isomaltoside (1000mg) safely increased hemoglobin levels after surgery in patients undergoing cardiac surgery. However, there have been no studies on the effect of ultra-short-term use of intravenous iron supplements prior to TAVI procedure.
Therefore, we investigate the effect of a single high-dose of iron isomaltoside (20mg/kg, maximum dose: 1g) on the hemoglobin concentration after the TAVI.
- Conditions
- Aortic Stenosis (Treated With TAVI)
- Being tested
- Normal saline, Iron isomaltoside
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineDrug
Participants in "Control group" are administered IV 100cc normal saline \& IM normal saline (1cc) 1 day before surgery.
Iron isomaltosideDrug
Participants in "Iron isomaltoside group" are administered IV Iron maltoside diluted in 100 cc normal saline (20mg/kg, maximum dose: 1g) \& IM Vitamin B12 (1mg) 1 day before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Participants in this group are administered N/S. Receives: Drug: Normal saline |
| Iron isomaltoside group | Experimental | Participants in this group are administered Iron isomaltoside \& Vitamin B12. Receives: Drug: Iron isomaltoside |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin (Hb) concentration
Compare the Hb concentrations between the Iron isomaltoside group and the Control group.
Measured: 1~3 days before TAVI (Baseline)
Hemoglobin (Hb) concentration
Compare the Hb concentrations between the Iron isomaltoside group and the Control group.
Measured: within 5 minutes after TAVI
Hemoglobin (Hb) concentration
Compare the Hb concentrations between the Iron isomaltoside group and the Control group.
Measured: 2 days after TAVI
Hemoglobin (Hb) concentration
Compare the Hb concentrations between the Iron isomaltoside group and the Control group.
Measured: 2 weeks after TAVI (when the participant has not been discharged for 2 weeks) or 1st outpatient visit after TAVI (when the participant has been discharged within 2 weeks)
Secondary outcomes (11)
Transfusion requirement
Compare the transfusion requirement between the Iron isomaltoside group and the Control group.
Measured: 1~3 days before TAVI (Baseline)
Transfusion requirement
Compare the transfusion requirement between the Iron isomaltoside group and the Control group.
Measured: During hospitalization period after TAVI, an average of 1 week
Transfusion requirement
Compare the transfusion requirement between the Iron isomaltoside group and the Control group.
Measured: During 2 weeks after TAVI (when the participant has not been discharged for 2 weeks) or until 1st outpatient visit after TAVI (when the participant has been discharged within 2 weeks)
Functional performance - Essential frailty toolset (EFT)
Compare the functional performance between the Iron isomaltoside group and the Control group.
Measured: 1~3 days before TAVI (Baseline)
Functional performance - Handgrip
Compare the functional performance between the Iron isomaltoside group and the Control group.
Measured: 1~3 days before TAVI (Baseline)
Functional performance - Essential frailty toolset (EFT)
Compare the functional performance between the Iron isomaltoside group and the Control group.
Measured: 2 weeks after TAVI (when the participant has not been discharged for 2 weeks) or 1st outpatient visit after TAVI (when the participant has been discharged within 2 weeks)
Functional performance - Handgrip
Compare the functional performance between the Iron isomaltoside group and the Control group.
Measured: 2 weeks after TAVI (when the participant has not been discharged for 2 weeks) or 1st outpatient visit after TAVI (when the participant has been discharged within 2 weeks)
Cognitive function - MMSE-K (Mini Mental State Exam)
Compare the cognitive function between the Iron isomaltoside group and the Control group.
Measured: 1~3 days before TAVI (Baseline)
Cognitive function - MMSE-K (Mini Mental State Exam)
Compare the cognitive function between the Iron isomaltoside group and the Control group.
Measured: 2 weeks after TAVI (when the participant has not been discharged for 2 weeks) or 1st outpatient visit after TAVI (when the participant has been discharged within 2 weeks)
Depression - SGDS-K (Short geriatric Depression Scale)
Compare the depression between the Iron isomaltoside group and the Control group.
Measured: 1~3 days before TAVI (Baseline)
Depression - SGDS-K (Short geriatric Depression Scale)
Compare the depression between the Iron isomaltoside group and the Control group.
Measured: 2 weeks after TAVI (when the participant has not been discharged for 2 weeks) or 1st outpatient visit after TAVI (when the participant has been discharged within 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start27 Apr 2020
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Stenosis (Treated With TAVI)Studies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are divided into 2 groups, who are administered Iron isomaltoside \& Vitamin B12 or who are administered Normal saline (N/S).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346004
- Sponsor's protocol ID
- 4-2020-0143
- Status last verified
- Apr 2020
- First submitted
- 6 Apr 2020
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Iron Isomaltoside 1000 Administration on Hemoglobin Concentration in Patients Undergoing Transcatheter Aortic Valve Implantation: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04346004
- Acronym / sponsor ID
- 4-2020-0143
- Conditions
- Aortic Stenosis (Treated With TAVI)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 15 Apr 2020 (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.
Transcatheter aortic valve implantation (TAVI) is a standard procedure for severe aortic stenosis patients with moderate or higher risk of surgery. Several studies have reported the adverse effects of blood disorders, such as anemia and iron deficiency, on the prognosis of patients undergoing TAVI, and many other studies have been conducted to find ways to prevent them.
Iron isomaltoside, the latest intravenous iron supplement, can effectively replenish iron store with a single high-dose injection. Research has shown that a preoperative single high-dose iron isomaltoside (1000mg) safely increased hemoglobin levels after surgery in patients undergoing cardiac surgery. However, there have been no studies on the effect of ultra-short-term use of intravenous iron supplements prior to TAVI procedure.
Therefore, we investigate the effect of a single high-dose of iron isomaltoside (20mg/kg, maximum dose: 1g) on the hemoglobin concentration after the TAVI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are divided into 2 groups, who are administered Iron isomaltoside \& Vitamin B12 or who are administered Normal saline (N/S).
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Normal salineParticipants in this group are administered N/S. |
| Iron isomaltoside group | Experimental | Drug: Iron isomaltosideParticipants in this group are administered Iron isomaltoside \& Vitamin B12. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients older than 60 years and undergoing transcatheter aortic valve implantation (TAVI)
Key exclusion criteria (18 listed)
- Emergency operation
- Cardiogenic shock or ventricular-assist device (eg. ECMO, IABP)
- Infectious condition
- Active bleeding
- Hypokalemia
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 |
|---|---|---|
| Normal salineParticipants in "Control group" are administered IV 100cc normal saline \& IM normal saline (1cc) 1 day before surgery. | Drug | Control group |
| Iron isomaltosideParticipants in "Iron isomaltoside group" are administered IV Iron maltoside diluted in 100 cc normal saline (20mg/kg, maximum dose: 1g) \& IM Vitamin B12 (1mg) 1 day before surgery. | Drug | Iron isomaltoside group |
Primary outcome
Hemoglobin (Hb) concentration
Time frame: 1~3 days before TAVI (Baseline)
Compare the Hb concentrations between the Iron isomaltoside group and the Control group.
Hemoglobin (Hb) concentration
Time frame: within 5 minutes after TAVI
Compare the Hb concentrations between the Iron isomaltoside group and the Control group.
Hemoglobin (Hb) concentration
Time frame: 2 days after TAVI
Compare the Hb concentrations between the Iron isomaltoside group and the Control group.
Hemoglobin (Hb) concentration
Time frame: 2 weeks after TAVI (when the participant has not been discharged for 2 weeks) or 1st outpatient visit after TAVI (when the participant has been discharged within 2 weeks)
Compare the Hb concentrations between the Iron isomaltoside group and the Control group.
11 secondary outcomes
Transfusion requirement
Time frame: 1~3 days before TAVI (Baseline)
Transfusion requirement
Time frame: During hospitalization period after TAVI, an average of 1 week
Transfusion requirement
Time frame: During 2 weeks after TAVI (when the participant has not been discharged for 2 weeks) or until 1st outpatient visit after TAVI (when the participant has been discharged within 2 weeks)
Functional performance - Essential frailty toolset (EFT)
Time frame: 1~3 days before TAVI (Baseline)
Functional performance - Handgrip
Time frame: 1~3 days before TAVI (Baseline)
Functional performance - Essential frailty toolset (EFT)
Time frame: 2 weeks after TAVI (when the participant has not been discharged for 2 weeks) or 1st outpatient visit after TAVI (when the participant has been discharged within 2 weeks)
Functional performance - Handgrip
Time frame: 2 weeks after TAVI (when the participant has not been discharged for 2 weeks) or 1st outpatient visit after TAVI (when the participant has been discharged within 2 weeks)
Cognitive function - MMSE-K (Mini Mental State Exam)
Time frame: 1~3 days before TAVI (Baseline)
Cognitive function - MMSE-K (Mini Mental State Exam)
Time frame: 2 weeks after TAVI (when the participant has not been discharged for 2 weeks) or 1st outpatient visit after TAVI (when the participant has been discharged within 2 weeks)
Depression - SGDS-K (Short geriatric Depression Scale)
Time frame: 1~3 days before TAVI (Baseline)
Depression - SGDS-K (Short geriatric Depression Scale)
Time frame: 2 weeks after TAVI (when the participant has not been discharged for 2 weeks) or 1st outpatient visit after TAVI (when the participant has been discharged within 2 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Normal saline and Iron isomaltoside in people with Aortic Stenosis (Treated With TAVI), run by Yonsei University at 1 site in South Korea.
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 1 inclusion and 18 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 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Jong Wook Song (82-2-2224-3971, SJW72331@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin (Hb) concentration (time frame: 1~3 days before TAVI (Baseline)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2020.