Sodium Intake in Failing Heart Patients.
Sodium Intake in Failing Heart Patients.
Patients with heart failure (HF) have an amelioration in clinical outcomes during a
 restricted dietary salt intake. To date, they experienced an amelioration of functional New
 York Association Heart (NYHA) class, reduction of hospital admissions, and mortality, in a
 percentage about 60%. However, these data have been not investigated in CRTd patients with HF
 under a condition of restricted vs. normal dietary salt intake. In the present study authors
 will evaluate clinical outcomes in patients treated by Cardiac Resynchronization Therapy with
 a defibrillator (CRT-d) and restricted dietary salt intake (group 1) in addition to
 conventional heart failure (HF) therapy vs. CRTd patients under conventional dietary salt
 intake and conventional HF therapy (group 2). The study will be conducted during a 12-months
 of follow-up, to evaluate the prognosis of CRTd patients treated with restricted (n 271) vs.
 a matched cohort of CRTd patients treated with normal salt dietary intake in addition to
 conventional HF therapy (n 288). Authors' opinion is that, restricted salt intake in addition
 to conventional HF therapy might significantly reduce body weight and heart chambers volumes
 in CRTd patients, leading to a significant improvement of ejection fraction and of the 6
 minutes walking test (6MWT), and to a reduction of the arrhythmic burden. Consequently,
 restricted salt intake in addition to conventional HF therapy might reduce hospital
 admissions for heart failure worsening.
Cardiac Resynchronization therapy with a defibrillator (CRTd) is a valid treatment for
 patients with heart failure and reduced left ventricle ejection fraction (HFrEF). Indeed,
 CRTd might induce an amelioration in New York Heart Association (NYHA) class, with a
 improvement of left ventricle ejection fraction (LVEF), and a reduction of hospital
 admissions for failing heart worsening. It is relevant to report that this ameliorative
 effect is seen only in a percentage about 70% of CRTd treated patients, that are called CRTd
 responders. However, about 30% of patients do not respond to CRTD, and they experience a
 worse clinical prognosis with an increasing trend toward heart failure (HF) disease
 progression, hospital admissions, and deaths. These patients are defined "CRTd non
 responders" . Actually, there is an increasing trend to find the mechanisms causing this
 therapeutic failure, such as a growing necessity to find new treatments to ameliorate CRTd
 effects, and to improve clinical outcomes in HFrEF patients with CRTd. In this setting,
 authors might speculate that salt and liquid retention represent a relevant pathogenic
 mechanism to cause worsening of NYHA class, with higher rate of hospital admissions for HF
 worsening and worse prognosis. Indeed, numerous studies reported the importance of a
 restricted vs. normal dietary salt intake in patients with HF to ameliorate clinical
 prognosis. Intriguingly, there are not studies investigating the effects of restricted
 dietary salt intake in failing heart patients with CRTd. Secondly, it is not well know how a
 restricted vs. normal dietary salt intake can affect clinical prognosis in CRTd patients.
 Therefore, the study hypothesis was that, a restricted dietary salt intake in addition to
 conventional anti-HF therapy as compared to the normal dietary salt intake in addition to
 conventional anti-HF drugs therapy might ameliorate heart function, and clinical outcomes in
 a population of HFrEF patients treated by CRT-d. Moreover, in this study authors will
 evaluate the effects of restricted vs. normal dietary salt intake in addition to conventional
 anti-HF in a population of failing heart patients treated by CRT-d. To date, in this study
 patients affected by HFrEF after CRT-d implant will be randomly divided in patients receiving
 restricted dietary salt intake plus conventional anti-HF therapy vs. patients under
 conventional dietary salt intake plus anti-HF therapy. In these patients authors will
 investigate at 12 months follow up all cause of deaths, cardiac deaths, hospitalizations for
 HF worsening, CRT-d responders rate, and the arrhythmic burden: atrial fibrillation (AF)
 events, ventricular tachycardia (VT) events, ventricular fibrillation (VF) events, internal
 cardioverter defibrillator (ICD) shocks, and strokes events.
Inclusion Criteria:

 -  heart failure in NYHA 2-3 class;

 -  patients under optimal and full medical therapy for HF;

 -  patients treated with CRTd;

 -  patients without neoplastic diseases;

 -  patients without inflammatory sistemic diseases.

 Exclusion Criteria:

 -  decompensated HF;

 -  unstable HF;

 -  patients without full anti-HF medical therapy;

 -  patients without indication to receive CRTd;

 -  patients with renal failure.