The Salt Study for Heart Failure

NCT07560592 | Recruiting

• 1 other identifier: Pro2025001253
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Keywords

Heart failure, Salt diet

Outcome Measures

Primary Outcomes (4)

• Length of hospital stay

  number of days the patient remains hospitalized

  Hospital admission to time of discharge assessed up to 1 year

• 30-day readmission

  readmission to hospital within 30 days of discharge from the index event

  30 days after discharge from hospital after index event

• NT-proBNP on discharge

  Measurement of blood levels of NT-ProBNP a biomarker for diagnosing and assessing the severity of heart failure.

  time of hospital admission to 30 days after discharge

• Loop diuretic requirement during index admission

  Furosemide, torsemide, and bumetanide are specific loop diuretics used in the treatment of fluid overload / retention conditions like congestive heart failure.

  time of hospital admission to 30 days after discharge

Study Arms (2)

Normal Salt Diet

EXPERIMENTAL

3-4 gm/day salt diet

Other: Normal Salt Diet

Cardiac Diet

PLACEBO COMPARATOR

2 gm/day salt diet

Other: Cardiac Diet

Interventions

Normal Salt Diet OTHER

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.

Normal Salt Diet

Cardiac Diet OTHER

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.

Cardiac Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Maya Guglin, MD: lead

Study Sites (1)

Robert Wood Johnson Barnabas Hospital - New Brunswick

New Brunswick, New Jersey, 08901, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Maya Guglin, MD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Guglin, MD

CONTACT

8483915776; maya.guglin@rutgers.edu

Manisha Bajpai, PhD

CONTACT

manisha.bajpai@rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Section Chief, Heart Failure/Transplant/MCS at Rutgers Robert Wood Johnson Medical School

Model Details: All patients with study ID ending in an odd number will be randomized to the Cardiac diet (control arm) and even number to the normal diet (interventional arm).

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: May 1, 2026
• Study Start: January 21, 2026
• Primary Completion (Estimated): November 10, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)