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Recruiting NCT07560592

The Salt Study for Heart Failure

No phase Interventional Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Normal Salt Diet, Cardiac Diet.
Who it may be relevant to
Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluating Effect of Low-Sodium and Regular Diets on Heart Failure Outcomes

Overview

The purpose of this study is to understand if low sodium (cardiac) diet is indeed necessary for better health outcomes in patients who suffered heart failure. This study will investigate the association between sodium intake and risk for 30-day re-admission in Heart Failure (HF) patients.

Interventions

  • Other Normal Salt Diet
    This study will allow regular diet 3-4 g Na-Salt per day in patients with acute HF as an intervention, because the standard recommendation for such patients is cardiac diet with 2 g Na per day. The intervention will end when the patient is discharged from the hospital. They will follow routine clinical care recommendations after discharge from hospital.
  • Other Cardiac Diet
    This arm of study will allow the cardiac diet with 2 g Na per day, that is standard recommendation for HF patients. They will follow routine clinical care recommendations after discharge from hospital.

Primary outcome measures

  • Length of hospital stay [Time frame: Hospital admission to time of discharge assessed up to 1 year]
  • 30-day readmission [Time frame: 30 days after discharge from hospital after index event]
  • NT-proBNP on discharge [Time frame: time of hospital admission to 30 days after discharge]
  • Loop diuretic requirement during index admission [Time frame: time of hospital admission to 30 days after discharge]

Eligibility criteria

Inclusion criteria

  • Above 18 years of age
  • Hospitalization due to Heart Failure admitted within 24 hours

Exclusion criteria

  • Concomitant hypertension (blood pressure >150/90 mmHg on admission)
  • End stage renal disease (on hemodialysis or peritoneal dialysis
  • Cardiogenic shock

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Robert Wood Johnson Barnabas Hospital - New Brunswick — New Brunswick

Identifiers

NCT: NCT07560592 · Pro2025001253

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗