Sodium Intake in Failing Heart Patients.

A Restricted Sodium Dietary Intake Reduces Hospital Admissions and Arrhythmic Burden in Patients Affected by Heart Failure With Reduced Ejection Fraction and Treated by Cardiac Resynchronization Therapy: Data From the SIRECART Registry

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Salt; Edema
• Intervention / Treatment: Other: restricted dietary salt intake

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.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80138
    • Raffaele Marfella

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
salt restricted diet; In this group the patients will received after CRTD a restricted (1500 grams/daily) salt intake.	Other: restricted dietary salt intake; These patients after CRTd will receive a restricted dietary salt intake. To date, the salt intake will be 1500 grams daily.
normal salt diet; In this group the patients will received after CRTD a normal (2500 grams/daily) salt intake.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with heart failure worsening events	Authors will report by telephonic interviews, clinical visits and hospital discharge schedules the patients with HF worsening events.	12 months

Collaborators and Investigators

• Sponsor: University of Campania "Luigi Vanvitelli"

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: June 21, 2019
• First Submitted That Met QC Criteria: June 25, 2019
• First Posted (Actual): June 26, 2019

Study Record Updates

• Last Update Posted (Actual): June 26, 2019
• Last Update Submitted That Met QC Criteria: June 25, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: SecondUNI 20.06.2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No