Aims Oral sucrosomial iron (SI) combines enhanced bioavailability and tolerance compared to conventional oral iron along with similar efficacy compared to intravenous iron in several conditions associated with iron deficiency (ID). Methods and results In this non‐randomized, open‐label study, we sought to evaluate prospectively the effects of SI on clinical parameters, exercise capacity and quality of life in 25 patients with heart failure (HF) with reduced ejection fraction (HFrEF) and ID, treated with SI 28 mg daily for 3 months, in comparison to 25 matched HFrEF controls. All patients were on optimal stable HF therapy. Patients were followed for 6 months for death or worsening HF episodes. There were no differences in baseline characteristics between groups. At 3 months, SI was associated with a significant increase in haemoglobin, serum iron and serum ferritin levels (all P ≤ 0.001) along with a significant improvement in 6‐min walked distance and Kansas City Cardiomyopathy Questionnaire (all P < 0.01), even after adjustment for baseline parameters; these differences persisted at 6 months. Over the study period, there were no deaths, while 10 patients (20%) in total (four in the SI group and six in the control group), experienced worsening HF (odds ratio 0.51, 95% confidence interval 0.41–6.79, P = 0.482). Drug‐associated diarrhoea was reported by one patient in the SI group and led to drug discontinuation; no other adverse events were reported. Conclusions In this proof‐of‐concept study, SI was well tolerated and improved exercise capacity and quality of life in HFrEF patients with ID. Randomized studies are required to further investigate the effects of this therapy.
Background and Aims In patients with chronic kidney disease (CKD) and heart failure (HF), renal venous congestion plays a key role in determining renal dysfunction and a worse prognosis. Αim of this ongoing study is to identify Doppler intrarenal venous flow patterns reflecting renal congestion in patients with CKD and HF and to detect possible associations with cardiac function parameters. Prognostic implications will be evaluated at a next stge. Method We prospectively enroll outpatients affected by CKD stages 3-4 and HF, in stable clinical conditions and in conventional therapy. All patients undergo clinical evaluation, routine biochemistry, transthoracic echocardiogram and renal echo-Doppler. Pulsed Doppler flow recording is performed at the level of the right interlobular renal veins at the end-expiratory phase. The intrarenal venous flow patterns are divided into five types according to the waveforms of the flow. Type A and B are characterized by a continuous flow and considered normal waveforms. Type C is characterized by a short interruption and/or reversal flow during the end-diastolic or protosystolic phase. Type D and E are characterized by a wide interruption and/or reversal flow, respectively. Types C, D and E are considered abnormal and reflect increasing venous pressure within the kidneys. Results Until now, 36 patients (27males / 9 females), 13 (36%) diabetics, aged 69.4±10.6 years old, have been included, and baseline characteristics are presented. Twenty patients (55%) have CKD stage 3, and 16 patients CKD stage 4 (45%). Fifteen (40%) of these patients have HF New York Heart Association (ΝΥΗA) class II, 18 (50%) ΝΥΗΑ class ΙΙΙ and 3 (10%) ΝΥΗΑ class IV. Mean ejection fraction (EF) is 34.5±7.8%, moderately reduced in 9 (25%) and severely reduced in 27 (75%) of these patients. By analyzing the waveforms, we noticed that 27 patients (75%) had venous patterns of continuous flow (type A 18% and type B 57%) and 9 (25%) had venous patterns with not continuous flows (21% type C and 4% type D). The patients with renal venous patterns A and B had higher EF than those with renal venous patterns C and D (36±8% vs. 30±5%, p=0.045). We have also observed that worsening HF according to NYHA classification was significantly associated to more pathological renal venous patterns (rho=0.402, p=0.034) Conclusion In patients with CKD and HF we may observe abnormal intrarenal vein flow patterns, in the context of renal congestion, related to the functional state of the heart. Further studies will indicate the clinical and prognostic significance of these measurements to better characterize patients with cardio-renal syndrome.
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