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Sodium Intake in Failing Heart Patients.

NCT03998891 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2019-06-26

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Campania Luigi Vanvitelli

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-01
Primary Completion
2017-06-01
Completion
2018-01-01

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03998891 on ClinicalTrials.gov