Trial Outcomes & Findings for Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis (NCT NCT04206228)
NCT ID: NCT04206228
Last Updated: 2026-04-15
Results Overview
The distance walked on a 6 min walk test performed 6 months after the trial intervention.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
149 participants
Primary outcome timeframe
6 months
Results posted on
2026-04-15
Participant Flow
Participant milestones
| Measure |
Active Treatment
Active drug: Intravenous iron isomaltoside dissolved in 100 ml NaCl 0.9 %
Intravenous iron isomaltoside: The active drug, iron isomaltoside, will be administered as a single, intravenous infusion of 20 mg/kg body weight (rounded off to the nearest 100 mg) dissolved in 100 ml NaCl as recommended by the drug manufacturer ("on-label" treatment), over 30 minutes only (1,67 ml/min).
|
Placebo
Placebo: Intravenous NaCl 0.9 % dissolved in 100 ml
Placebo: The placebo will be prepared according to the randomisation code, and administered as a single intravenous infusion over 30 minutes only (1,67 ml/min).
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
75
|
|
Overall Study
COMPLETED
|
51
|
53
|
|
Overall Study
NOT COMPLETED
|
23
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis
Baseline characteristics by cohort
| Measure |
Active Treatment
n=51 Participants
Active drug: Intravenous ferric derisomaltose dissolved in 100 ml NaCl 0.9 %
Intravenous iron isomaltoside: The active drug, ferric derisomaltose (formerly known as iron isomaltoside), will be administered as a single, intravenous infusion of 20 mg/kg body weight (rounded off to the nearest 100 mg) dissolved in 100 ml NaCl as recommended by the drug manufacturer ("on-label" treatment), over 30 minutes only (1,67 ml/min).
|
Placebo
n=53 Participants
Placebo: Intravenous NaCl 0.9 % dissolved in 100 ml
Placebo: The placebo will be prepared according to the randomisation code, and administered as a single intravenous infusion over 30 minutes only (1,67 ml/min).
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=193 Participants
|
53 Participants
n=193 Participants
|
104 Participants
n=386 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Region of Enrollment
Norway
|
51 participants
n=193 Participants
|
53 participants
n=193 Participants
|
104 participants
n=386 Participants
|
|
6-minute walk test
|
355 meters
STANDARD_DEVIATION 113 • n=193 Participants
|
367 meters
STANDARD_DEVIATION 129 • n=193 Participants
|
361 meters
STANDARD_DEVIATION 121 • n=386 Participants
|
|
Age, Continuous
|
80 years
STANDARD_DEVIATION 8 • n=193 Participants
|
79 years
STANDARD_DEVIATION 7 • n=193 Participants
|
80 years
STANDARD_DEVIATION 7 • n=386 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=193 Participants
|
21 Participants
n=193 Participants
|
44 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=193 Participants
|
32 Participants
n=193 Participants
|
60 Participants
n=386 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Only the patients who attended the follow-up visit was included in outcome measure data
The distance walked on a 6 min walk test performed 6 months after the trial intervention.
Outcome measures
| Measure |
Active Treatment
n=51 Participants
Active drug: Intravenous ferric derisomaltose dissolved in 100 ml NaCl 0.9 %
Intravenous iron isomaltoside: The active drug, ferric derisomaltose, will be administered as a single, intravenous infusion of 20 mg/kg body weight (rounded off to the nearest 100 mg) dissolved in 100 ml NaCl as recommended by the drug manufacturer ("on-label" treatment), over 30 minutes only (1,67 ml/min).
|
Placebo
n=53 Participants
Placebo: Intravenous NaCl 0.9 % dissolved in 100 ml
Placebo: The placebo will be prepared according to the randomisation code, and administered as a single intravenous infusion over 30 minutes only (1,67 ml/min).
|
|---|---|---|
|
Submaximal Exercise Test
|
375 meters
Standard Deviation 132
|
384 meters
Standard Deviation 128
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Only the patients who attended the 3 month follow-up visit was included in the outcome measure data
Iron deficiency defined as serum ferritin \< 100 µg/l or ferritin between 100 and 300 µg/l in combination with a transferrin saturation \< 20 %.
Outcome measures
| Measure |
Active Treatment
n=51 Participants
Active drug: Intravenous ferric derisomaltose dissolved in 100 ml NaCl 0.9 %
Intravenous iron isomaltoside: The active drug, ferric derisomaltose, will be administered as a single, intravenous infusion of 20 mg/kg body weight (rounded off to the nearest 100 mg) dissolved in 100 ml NaCl as recommended by the drug manufacturer ("on-label" treatment), over 30 minutes only (1,67 ml/min).
|
Placebo
n=53 Participants
Placebo: Intravenous NaCl 0.9 % dissolved in 100 ml
Placebo: The placebo will be prepared according to the randomisation code, and administered as a single intravenous infusion over 30 minutes only (1,67 ml/min).
|
|---|---|---|
|
Iron Deficiency
|
12 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: 6 monthsGrip strength will be measure using a hand-held dynamometer (hand-grip device).
Outcome measures
| Measure |
Active Treatment
n=51 Participants
Active drug: Intravenous ferric derisomaltose dissolved in 100 ml NaCl 0.9 %
Intravenous iron isomaltoside: The active drug, ferric derisomaltose, will be administered as a single, intravenous infusion of 20 mg/kg body weight (rounded off to the nearest 100 mg) dissolved in 100 ml NaCl as recommended by the drug manufacturer ("on-label" treatment), over 30 minutes only (1,67 ml/min).
|
Placebo
n=53 Participants
Placebo: Intravenous NaCl 0.9 % dissolved in 100 ml
Placebo: The placebo will be prepared according to the randomisation code, and administered as a single intravenous infusion over 30 minutes only (1,67 ml/min).
|
|---|---|---|
|
Muscle Strength
|
28 kilograms
Standard Deviation 10
|
32 kilograms
Standard Deviation 12
|
SECONDARY outcome
Timeframe: 6 monthsThe SF-36 Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
Active Treatment
n=51 Participants
Active drug: Intravenous ferric derisomaltose dissolved in 100 ml NaCl 0.9 %
Intravenous iron isomaltoside: The active drug, ferric derisomaltose, will be administered as a single, intravenous infusion of 20 mg/kg body weight (rounded off to the nearest 100 mg) dissolved in 100 ml NaCl as recommended by the drug manufacturer ("on-label" treatment), over 30 minutes only (1,67 ml/min).
|
Placebo
n=53 Participants
Placebo: Intravenous NaCl 0.9 % dissolved in 100 ml
Placebo: The placebo will be prepared according to the randomisation code, and administered as a single intravenous infusion over 30 minutes only (1,67 ml/min).
|
|---|---|---|
|
The 36-item Short Health Survey Questionnaire (SF-36) Summary PCS
|
45 score
Interval 35.0 to 51.0
|
43 score
Interval 36.0 to 51.0
|
SECONDARY outcome
Timeframe: 6 monthsScores on a scale. The results are reported as the EQ-5D summary index which is a standardized, single-index score representing health-related quality of life (HRQoL) ranging from 0 to 1, where 1 is perfect health.
Outcome measures
| Measure |
Active Treatment
n=51 Participants
Active drug: Intravenous ferric derisomaltose dissolved in 100 ml NaCl 0.9 %
Intravenous iron isomaltoside: The active drug, ferric derisomaltose, will be administered as a single, intravenous infusion of 20 mg/kg body weight (rounded off to the nearest 100 mg) dissolved in 100 ml NaCl as recommended by the drug manufacturer ("on-label" treatment), over 30 minutes only (1,67 ml/min).
|
Placebo
n=53 Participants
Placebo: Intravenous NaCl 0.9 % dissolved in 100 ml
Placebo: The placebo will be prepared according to the randomisation code, and administered as a single intravenous infusion over 30 minutes only (1,67 ml/min).
|
|---|---|---|
|
The 3-level Version of EQ-5D (EQ-5D-3L) Questionnaire
|
0.91 Score
Interval 0.82 to 0.97
|
0.91 Score
Interval 0.78 to 0.91
|
SECONDARY outcome
Timeframe: 6 monthsEQ-VAS is an instrument to measure overall health on a vertical visual analogue scale, ranging from "worst possible" (zero) to "best possible" (100)health.
Outcome measures
| Measure |
Active Treatment
n=51 Participants
Active drug: Intravenous ferric derisomaltose dissolved in 100 ml NaCl 0.9 %
Intravenous iron isomaltoside: The active drug, ferric derisomaltose, will be administered as a single, intravenous infusion of 20 mg/kg body weight (rounded off to the nearest 100 mg) dissolved in 100 ml NaCl as recommended by the drug manufacturer ("on-label" treatment), over 30 minutes only (1,67 ml/min).
|
Placebo
n=53 Participants
Placebo: Intravenous NaCl 0.9 % dissolved in 100 ml
Placebo: The placebo will be prepared according to the randomisation code, and administered as a single intravenous infusion over 30 minutes only (1,67 ml/min).
|
|---|---|---|
|
EuroQol-visual Analogue Scales (EQ-VAS)
|
70 Score
Interval 48.0 to 84.0
|
75 Score
Interval 60.0 to 85.0
|
SECONDARY outcome
Timeframe: 6 monthsThe KCCQ Overall Summary Score (OSS) is a 0-100 scale measuring heart failure health status, where higher scores indicate better quality of life and fewer symptoms.
Outcome measures
| Measure |
Active Treatment
n=51 Participants
Active drug: Intravenous ferric derisomaltose dissolved in 100 ml NaCl 0.9 %
Intravenous iron isomaltoside: The active drug, ferric derisomaltose, will be administered as a single, intravenous infusion of 20 mg/kg body weight (rounded off to the nearest 100 mg) dissolved in 100 ml NaCl as recommended by the drug manufacturer ("on-label" treatment), over 30 minutes only (1,67 ml/min).
|
Placebo
n=53 Participants
Placebo: Intravenous NaCl 0.9 % dissolved in 100 ml
Placebo: The placebo will be prepared according to the randomisation code, and administered as a single intravenous infusion over 30 minutes only (1,67 ml/min).
|
|---|---|---|
|
The Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
|
88 Score
Interval 71.0 to 95.0
|
82 Score
Interval 65.0 to 94.0
|
SECONDARY outcome
Timeframe: 6 monthsNT-proBNP is measured as a simple blood test and used as diagnostic biomarker for heart failure and cardiac dysfunction in clinical medicine.
Outcome measures
| Measure |
Active Treatment
n=51 Participants
Active drug: Intravenous ferric derisomaltose dissolved in 100 ml NaCl 0.9 %
Intravenous iron isomaltoside: The active drug, ferric derisomaltose, will be administered as a single, intravenous infusion of 20 mg/kg body weight (rounded off to the nearest 100 mg) dissolved in 100 ml NaCl as recommended by the drug manufacturer ("on-label" treatment), over 30 minutes only (1,67 ml/min).
|
Placebo
n=53 Participants
Placebo: Intravenous NaCl 0.9 % dissolved in 100 ml
Placebo: The placebo will be prepared according to the randomisation code, and administered as a single intravenous infusion over 30 minutes only (1,67 ml/min).
|
|---|---|---|
|
N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)
|
611 ng/L
Interval 338.0 to 1561.0
|
873 ng/L
Interval 451.0 to 1265.0
|
SECONDARY outcome
Timeframe: 6 monthsTnT is measured as a simple blood test and used as a standard biomarker of myocardial injury.
Outcome measures
| Measure |
Active Treatment
n=51 Participants
Active drug: Intravenous ferric derisomaltose dissolved in 100 ml NaCl 0.9 %
Intravenous iron isomaltoside: The active drug, ferric derisomaltose, will be administered as a single, intravenous infusion of 20 mg/kg body weight (rounded off to the nearest 100 mg) dissolved in 100 ml NaCl as recommended by the drug manufacturer ("on-label" treatment), over 30 minutes only (1,67 ml/min).
|
Placebo
n=53 Participants
Placebo: Intravenous NaCl 0.9 % dissolved in 100 ml
Placebo: The placebo will be prepared according to the randomisation code, and administered as a single intravenous infusion over 30 minutes only (1,67 ml/min).
|
|---|---|---|
|
Cardiac Troponin T (TnT)
|
19 ng/L
Interval 13.0 to 30.0
|
22 ng/L
Interval 14.0 to 35.0
|
SECONDARY outcome
Timeframe: 6 monthsThe NYHA (New York Heart Association) Functional Classification is a 4-stage system that ranks the severity of heart failure based on a patient's physical limitations and symptoms from 1 (no symptoms) to 4 (worst, symptoms at rest).
Outcome measures
| Measure |
Active Treatment
n=51 Participants
Active drug: Intravenous ferric derisomaltose dissolved in 100 ml NaCl 0.9 %
Intravenous iron isomaltoside: The active drug, ferric derisomaltose, will be administered as a single, intravenous infusion of 20 mg/kg body weight (rounded off to the nearest 100 mg) dissolved in 100 ml NaCl as recommended by the drug manufacturer ("on-label" treatment), over 30 minutes only (1,67 ml/min).
|
Placebo
n=53 Participants
Placebo: Intravenous NaCl 0.9 % dissolved in 100 ml
Placebo: The placebo will be prepared according to the randomisation code, and administered as a single intravenous infusion over 30 minutes only (1,67 ml/min).
|
|---|---|---|
|
New York Heart Association Functional Class
NYHA 1
|
35 Participants
|
30 Participants
|
|
New York Heart Association Functional Class
NYHA 2
|
15 Participants
|
20 Participants
|
|
New York Heart Association Functional Class
NYHA 3
|
1 Participants
|
3 Participants
|
|
New York Heart Association Functional Class
NYHA 4
|
0 Participants
|
0 Participants
|
POST_HOC outcome
Timeframe: 6 monthsCANTAB (www.cambridgecognition.com) is a computer-based cognitive assessment system consisting of a battery of seven neuropsychological tests, administered to subjects using a touch screen computer. Automatic scoring, adjusted for age, gender and education level.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: All patients who were randomised were assessed for adverse events during follow-up.
Prespecified safety endpoint
Outcome measures
| Measure |
Active Treatment
n=73 Participants
Active drug: Intravenous ferric derisomaltose dissolved in 100 ml NaCl 0.9 %
Intravenous iron isomaltoside: The active drug, ferric derisomaltose, will be administered as a single, intravenous infusion of 20 mg/kg body weight (rounded off to the nearest 100 mg) dissolved in 100 ml NaCl as recommended by the drug manufacturer ("on-label" treatment), over 30 minutes only (1,67 ml/min).
|
Placebo
n=75 Participants
Placebo: Intravenous NaCl 0.9 % dissolved in 100 ml
Placebo: The placebo will be prepared according to the randomisation code, and administered as a single intravenous infusion over 30 minutes only (1,67 ml/min).
|
|---|---|---|
|
Adverse Events
|
53 participants
|
66 participants
|
Adverse Events
Active Treatment
Serious events: 37 serious events
Other events: 16 other events
Deaths: 2 deaths
Placebo
Serious events: 49 serious events
Other events: 17 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Active Treatment
n=73 participants at risk
Active drug: Intravenous ferric derisomaltose dissolved in 100 ml NaCl 0.9 % administered as a single, intravenous infusion of 20 mg/kg body weight (rounded off to the nearest 100 mg), over 30 minutes only (1,67 ml/min).
|
Placebo
n=75 participants at risk
Placebo: Intravenous NaCl 0.9 % dissolved in 100 ml administered as a single intravenous infusion over 30 minutes only (1,67 ml/min).
|
|---|---|---|
|
Infections and infestations
Infections
|
6.8%
5/73 • Number of events 5 • From enrollment to follow-up, up to 6 months.
149 patients were included in the IIISAS trial and allocated to treatment, of whom 74 patients were randomised to ferric derisomaltose and 75 patients received placebo. Of these, 104 patients received TAVI and attented the three month follow-up visit (approximately 6 months after randomisation). For the adverse events all 149 patients are included whilst for the other outcome measures, only the 104 patients who attended follw-up were included (the modified intention to treat population).
|
8.0%
6/75 • Number of events 6 • From enrollment to follow-up, up to 6 months.
149 patients were included in the IIISAS trial and allocated to treatment, of whom 74 patients were randomised to ferric derisomaltose and 75 patients received placebo. Of these, 104 patients received TAVI and attented the three month follow-up visit (approximately 6 months after randomisation). For the adverse events all 149 patients are included whilst for the other outcome measures, only the 104 patients who attended follw-up were included (the modified intention to treat population).
|
|
Immune system disorders
Hypersensitivity reactions
|
1.4%
1/73 • Number of events 1 • From enrollment to follow-up, up to 6 months.
149 patients were included in the IIISAS trial and allocated to treatment, of whom 74 patients were randomised to ferric derisomaltose and 75 patients received placebo. Of these, 104 patients received TAVI and attented the three month follow-up visit (approximately 6 months after randomisation). For the adverse events all 149 patients are included whilst for the other outcome measures, only the 104 patients who attended follw-up were included (the modified intention to treat population).
|
0.00%
0/75 • From enrollment to follow-up, up to 6 months.
149 patients were included in the IIISAS trial and allocated to treatment, of whom 74 patients were randomised to ferric derisomaltose and 75 patients received placebo. Of these, 104 patients received TAVI and attented the three month follow-up visit (approximately 6 months after randomisation). For the adverse events all 149 patients are included whilst for the other outcome measures, only the 104 patients who attended follw-up were included (the modified intention to treat population).
|
|
Cardiac disorders
Deaths
|
2.7%
2/73 • Number of events 2 • From enrollment to follow-up, up to 6 months.
149 patients were included in the IIISAS trial and allocated to treatment, of whom 74 patients were randomised to ferric derisomaltose and 75 patients received placebo. Of these, 104 patients received TAVI and attented the three month follow-up visit (approximately 6 months after randomisation). For the adverse events all 149 patients are included whilst for the other outcome measures, only the 104 patients who attended follw-up were included (the modified intention to treat population).
|
6.7%
5/75 • Number of events 5 • From enrollment to follow-up, up to 6 months.
149 patients were included in the IIISAS trial and allocated to treatment, of whom 74 patients were randomised to ferric derisomaltose and 75 patients received placebo. Of these, 104 patients received TAVI and attented the three month follow-up visit (approximately 6 months after randomisation). For the adverse events all 149 patients are included whilst for the other outcome measures, only the 104 patients who attended follw-up were included (the modified intention to treat population).
|
|
Cardiac disorders
Outcomes related to TAVI
|
39.7%
29/73 • Number of events 29 • From enrollment to follow-up, up to 6 months.
149 patients were included in the IIISAS trial and allocated to treatment, of whom 74 patients were randomised to ferric derisomaltose and 75 patients received placebo. Of these, 104 patients received TAVI and attented the three month follow-up visit (approximately 6 months after randomisation). For the adverse events all 149 patients are included whilst for the other outcome measures, only the 104 patients who attended follw-up were included (the modified intention to treat population).
|
50.7%
38/75 • Number of events 38 • From enrollment to follow-up, up to 6 months.
149 patients were included in the IIISAS trial and allocated to treatment, of whom 74 patients were randomised to ferric derisomaltose and 75 patients received placebo. Of these, 104 patients received TAVI and attented the three month follow-up visit (approximately 6 months after randomisation). For the adverse events all 149 patients are included whilst for the other outcome measures, only the 104 patients who attended follw-up were included (the modified intention to treat population).
|
Other adverse events
| Measure |
Active Treatment
n=73 participants at risk
Active drug: Intravenous ferric derisomaltose dissolved in 100 ml NaCl 0.9 % administered as a single, intravenous infusion of 20 mg/kg body weight (rounded off to the nearest 100 mg), over 30 minutes only (1,67 ml/min).
|
Placebo
n=75 participants at risk
Placebo: Intravenous NaCl 0.9 % dissolved in 100 ml administered as a single intravenous infusion over 30 minutes only (1,67 ml/min).
|
|---|---|---|
|
Investigations
Mild infusion reactions, mild symptoms/events not defined as serious adverse events.
|
21.9%
16/73 • Number of events 16 • From enrollment to follow-up, up to 6 months.
149 patients were included in the IIISAS trial and allocated to treatment, of whom 74 patients were randomised to ferric derisomaltose and 75 patients received placebo. Of these, 104 patients received TAVI and attented the three month follow-up visit (approximately 6 months after randomisation). For the adverse events all 149 patients are included whilst for the other outcome measures, only the 104 patients who attended follw-up were included (the modified intention to treat population).
|
22.7%
17/75 • Number of events 17 • From enrollment to follow-up, up to 6 months.
149 patients were included in the IIISAS trial and allocated to treatment, of whom 74 patients were randomised to ferric derisomaltose and 75 patients received placebo. Of these, 104 patients received TAVI and attented the three month follow-up visit (approximately 6 months after randomisation). For the adverse events all 149 patients are included whilst for the other outcome measures, only the 104 patients who attended follw-up were included (the modified intention to treat population).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place