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Changes in myocardial iron content following administration of intravenous iron (Myocardial-IRON): Study design.

ABSTRACT: Treatment with intravenous ferric carboxymaltose (FCM) has been shown to improve symptoms, functional capacity, and quality of life in patients with heart failure and iron deficiency. However, the underlying mechanisms for these beneficial effects remain undetermined. The aim of this study is to quantify cardiac magnetic resonance changes in myocardial iron content after administration of intravenous FCM in patients with heart failure and iron deficiency and contrast them with parameters of heart failure severity. This is a multicenter, double-blind, randomized study. Fifty patients with stable symptomatic heart failure, left ventricular ejection fraction <50%, and iron deficiency will be randomly assigned 1:1 to receive intravenous FCM or placebo. Intramyocardial iron will be evaluated by T2* and T1 mapping cardiac magnetic resonance sequences before and at 7 and 30?days after FCM. After 30?days, patients assigned to placebo will receive intravenous FCM in case of persistent iron deficiency. The main endpoint will be changes from baseline in myocardial iron content at 7 and 30?days. Secondary endpoints will include the correlation of these changes with left ventricular ejection fraction, functional capacity, quality of life, and cardiac biomarkers. The results of this study will add important knowledge about the effects of intravenous FCM on myocardial tissue and cardiac function. We hypothesize that short-term (7 and 30?days) myocardial iron content changes after intravenous FCM, evaluated by cardiac magnetic resonance, will correlate with simultaneous changes in parameters of heart failure severity. The study is registered at http://www.clinicaltrials.gov (NCT03398681).

SUBMITTER: Minana G

PROVIDER: S-EPMC6489786 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Changes in myocardial iron content following administration of intravenous iron (Myocardial-IRON): Study design.

Miñana Gema G Cardells Ingrid I Palau Patricia P Llàcer Pau P Fácila Lorenzo L Almenar Luis L López-Lereu Maria Pilar MP Monmeneu Jose V JV Amiguet Martina M González Jessika J Serrano Alicia A Montagud Vicente V López-Vilella Raquel R Valero Ernesto E García-Blas Sergio S Bodí Vicent V de la Espriella-Juan Rafael R Sanchis Juan J Chorro Francisco J FJ Bayés-Genís Antoni A Núñez Julio J

Clinical cardiology 20180605 6

Treatment with intravenous ferric carboxymaltose (FCM) has been shown to improve symptoms, functional capacity, and quality of life in patients with heart failure and iron deficiency. However, the underlying mechanisms for these beneficial effects remain undetermined. The aim of this study is to quantify cardiac magnetic resonance changes in myocardial iron content after administration of intravenous FCM in patients with heart failure and iron deficiency and contrast them with parameters of hear ...[more]

PMID: 29607528

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Project description:BackgroundCognitive impairment is commonly reported in patients receiving chemotherapy, but the acuity of onset is not known. This study utilized the psychomotor vigilance test (PVT) and trail-making test B (TMT-B) to assess cognitive impairment immediately post-chemotherapy.MethodsPatients aged 18-80?years receiving first-line intravenous chemotherapy for any stage of breast or colorectal cancer were eligible. Patient symptoms, peripheral neuropathy and Stanford Sleepiness Scale were assessed. A five-minute PVT and TMT-B were completed on a tablet computer pre-chemotherapy and immediately post-chemotherapy. Using a mixed linear regression model, changes in reciprocal transformed PVT reaction time (mean 1/RT) were assessed. A priori, an increase in median PVT reaction times by >?20?ms (approximating PVT changes with blood alcohol concentrations of 0.04-0.05?g%) was considered clinically relevant.ResultsOne hundred forty-two cancer patients (73 breast, 69 colorectal, median age 55.5?years) were tested. Post-chemotherapy, mean 1/RT values were significantly slowed compared to pre-chemotherapy baseline (p?=?0.01). This corresponded to a median PVT reaction time slowed by an average of 12.4?ms. Changes in PVT reaction times were not correlated with age, sex, cancer type, treatment setting, or use of supportive medications. Median post-chemotherapy PVT reaction time slowed by an average of 22.5?ms in breast cancer patients and by 1.6?ms in colorectal cancer patients. Post-chemotherapy median PVT times slowed by >?20?ms in 57 patients (40.1%). Exploratory analyses found no statistically significant association between the primary outcome and self-reported anxiety, fatigue or depression. TMT-B completion speed improved significantly post-chemotherapy (p?=?0.03), likely due to test-retest phenomenon.ConclusionsPVT reaction time slowed significantly immediately post-chemotherapy compared to a pre-chemotherapy baseline, and levels of impairment similar to effects of alcohol consumption in other studies was seen in 40% of patients. Further studies assessing functional impact of cognitive impairment on patients immediately after chemotherapy are warranted.

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Changes in myocardial iron content following administration of intravenous iron (Myocardial-IRON): Study design.

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Changes in myocardial iron content following administration of intravenous iron (Myocardial-IRON): Study design.

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