Sodium Intake in Failing Heart Patients.
Condition: Heart Failure; Salt; Edema
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): restricted dietary salt intake
Intervention type(s): Other
Intervention description(s): These patients after CRTd will receive a restricted dietary salt intake. To date, the salt intake will be 1500 grams daily.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A population of patients affected by a stable and chronic heart failure in NYHA 2-3 class,
        and under optimal and full medical anti-HF therapy. These patients treated with CRTd will
        be aged between 18 and 75 years.