Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ziekenhuis Oost-Limburg | OTHER |
Not provided
Not provided
Not provided
Not provided
To assess impact on left ventricular reverse remodeling defined as a change in left ventricular ejection fraction in heart failure patients with reduced ejection fraction (and previous implantation of cardiac resynchronization therapy) undergoing treatment with ferric carboxymaltose vs. placebo
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferric carboxymaltose | Experimental | Ferric carboxymaltose according to SmPC |
|
| Placebo | Placebo Comparator | Normal saline (0.9%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric Carboxymaltose | Drug | Ferric carboxymaltose will be administered according to product specification dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in left ventricular ejection fraction from baseline | delta_LVEF measured by 3D-echocardiography | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in left ventricular end systolic volume from baseline | delta_LVESV measured by 3D-echocardiography | 3 months |
| Change in left ventricular end diastolic volume from baseline | delta_LVEDV measured by 3D-echocardiography |
| Measure | Description | Time Frame |
|---|---|---|
| Predefined right ventricular (RV) analysis | Assessment of effect of FCM on RV-function at rest and during incremental pacing. Assessment of RV-to-pulmonary artery coupling | 3 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pieter Martens | Genk | Limburg | 3500 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34185066 | Result | Martens P, Dupont M, Dauw J, Nijst P, Herbots L, Dendale P, Vandervoort P, Bruckers L, Tang WHW, Mullens W. The effect of intravenous ferric carboxymaltose on cardiac reverse remodelling following cardiac resynchronization therapy-the IRON-CRT trial. Eur Heart J. 2021 Dec 21;42(48):4905-4914. doi: 10.1093/eurheartj/ehab411. |
Not provided
Not provided
Yes, full patient level data
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | IV nacl 0.9% |
|
| 3 months |
| Force frequency relationship | measured by 2D-echocardiography | 3 months |
| Heart failure hospitalization and all-cause mortality | measured by telephone contact | Up to six months |
| Incidence of Treatment-associated Serious and non-serious adverse events. | Serious and non-serious adverse events (AE) will be registered, which include:start date AE, duration AE, end-date AE, treatment group, continuation of AE after dose interruption, causality with study medication, presence of risk factors for AE and response to AE (sequela or recovery). | During intravenous study drug administration and 1-hour in hospital follow-up |