Sodium Intake in Failing Heart Patients.

June 25, 2019 updated by: Celestino Sardu, University of Campania "Luigi Vanvitelli"

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80138
        • Raffaele Marfella

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with heart failure worsening events
Time Frame: 12 months
Authors will report by telephonic interviews, clinical visits and hospital discharge schedules the patients with HF worsening events.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Campania "Luigi Vanvitelli"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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