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NCT06764225Recruiting

Effects of Low-Sodium Salt on Death, HF Hospitalization/ Emergency Department Visits and Quality of Life in HF Patients

Effects of Low-Sodium Substitute Salt on Death, Heart Failure Hospitalization, Heart Failure Emergency Department Visits, and Quality of Life in Patients With Heart Failure: A Multicenter, Double-Blind, Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 21 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This study aims to investigate whether using a low-sodium substitute salt can help improve outcomes for patients with heart failure. Specifically, it will examine if the low-sodium substitute salt can reduce death rates, hospital readmissions, and emergency visits, as well as improve the quality of life for these patients.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
1301 (estimated)
First submitted
24 Dec 2024
Start date
3 Apr 2025
Primary completion date
30 Apr 2027
Lead sponsor
Heart Health Research Center
NCT number
NCT06764225

What you commit to

  • Study type: Interventional
  • Planned participants: 1301
  • From 3 Apr 2025 to the primary completion date, 30 Apr 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • End-stage heart failure;
  • Malignant cancer patients with a life expectancy of less than 1 year;
  • Conditions that, in the investigator's opinion, may interfere with adherence to the protocol, such as habitual reliance on takeout meals or dining at company cafeterias;

Lab values

  • Uncorrected hyponatremia (Na \< 130 mmol/L);
  • Dialysis-dependent patients, or eGFR \< 20 mL/min/1.73m²;
  • Uncontrolled hyperglycemia, with fasting blood glucose \> 16 mmol/L;

Other

  • Hospitalization due to cardiovascular causes within the past month;
  • Planned hospitalization during the study period;
  • Unexplained weight loss greater than 5 kg in the past year;
  • The subject or family members have concerns about using the salt substitute in this study, or are planning for pregnancy, pregnant, or breastfeeding;
  • Another family member is already participating in this study;
  • The subject or family members are participating in other interventional clinical trials.

Who the study is looking for

  • Aged between 18 and 75 years;
  • Hospitalized due to heart failure in the past year;
  • NYHA functional class II-III;
  • Echocardiographic evidence of LVEF \< 40% within the past 6 months;
  • Receiving guideline-directed medical therapy for heart failure;
  • Stable heart failure status, defined as heart failure stability for more than 4 weeks, with no increase in diuretic dose within the past 4 weeks;
  • Having a primary caregiver and frequently dining together at home;
  • Consuming commercially processed food no more than once a week;
  • Providing written informed consent.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Anzhen Hospital, Capital Medical University
Coordinator of this site? Confirm its status
BeijingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.