Sodium Intake in Failing Heart Patients.

NCT03998891 | Completed

• 1 other identifier: SecondUNI 20.06.2019
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure; Salt; Edema

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

salt restricted diet

In this group the patients will received after CRTD a restricted (1500 grams/daily) salt intake.

Other: restricted dietary salt intake

normal salt diet

In this group the patients will received after CRTD a normal (2500 grams/daily) salt intake.

Interventions

restricted dietary salt intake OTHER

These patients after CRTd will receive a restricted dietary salt intake. To date, the salt intake will be 1500 grams daily.

salt restricted diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• decompensated HF;
• unstable HF;
• patients without full anti-HF medical therapy;
• patients without indication to receive CRTd;
• patients with renal failure.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Raffaele Marfella

Naples, 80138, Italy

Location

MeSH Terms

Conditions

Heart Failure; Edema

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 26, 2019
• Study Start: January 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: January 1, 2018
• Last Updated: June 26, 2019

Record last verified: 2019-06

Locations

IT (1)