Condition or disease | Intervention/treatment |
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Heart Failure Salt; Edema | Other: restricted dietary salt intake |
Study Type : | Observational |
Actual Enrollment : | 500 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | 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 |
Actual Study Start Date : | January 1, 2013 |
Actual Primary Completion Date : | June 1, 2017 |
Actual Study Completion Date : | January 1, 2018 |
Group/Cohort | Intervention/treatment |
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salt restricted diet
In this group the patients will received after CRTD a restricted (1500 grams/daily) salt intake.
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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.
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normal salt diet
In this group the patients will received after CRTD a normal (2500 grams/daily) salt intake.
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Italy | |
Raffaele Marfella | |
Naples, Italy, 80138 |
Tracking Information | |||||
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First Submitted Date | June 21, 2019 | ||||
First Posted Date | June 26, 2019 | ||||
Last Update Posted Date | June 26, 2019 | ||||
Actual Study Start Date | January 1, 2013 | ||||
Actual Primary Completion Date | June 1, 2017 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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.
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Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Sodium Intake in Failing Heart Patients. | ||||
Official Title | 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 | ||||
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. | ||||
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 | ||||
Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
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. | ||||
Condition |
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Intervention | 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.
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
500 | ||||
Original Actual Enrollment | Same as current | ||||
Actual Study Completion Date | January 1, 2018 | ||||
Actual Primary Completion Date | June 1, 2017 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Italy | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03998891 | ||||
Other Study ID Numbers | SecondUNI 20.06.2019 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | Celestino Sardu, University of Campania "Luigi Vanvitelli" | ||||
Study Sponsor | University of Campania "Luigi Vanvitelli" | ||||
Collaborators | Not Provided | ||||
Investigators | Not Provided | ||||
PRS Account | University of Campania "Luigi Vanvitelli" | ||||
Verification Date | June 2019 |