- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07560592
The Salt Study for Heart Failure
April 27, 2026 updated by: Maya Guglin, MD
Evaluating Effect of Low-Sodium and Regular Diets on Heart Failure Outcomes
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Maya Guglin, MD
- Phone Number: 8483915776
- Email: maya.guglin@rutgers.edu
Study Contact Backup
- Name: Manisha Bajpai, PhD
- Email: manisha.bajpai@rutgers.edu
Study Locations
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 08901
- Recruiting
- Robert Wood Johnson Barnabas Hospital - New Brunswick
-
Contact:
- Maya Guglin, MD
- Phone Number: 8483915776
- Email: maya.guglin@rutgers.edu
-
Contact:
- Manisha Bajpai, PhD
- Email: manisha.bajpai@rutgers.edu
-
-
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
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
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Normal Salt Diet
3-4 gm/day 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.
|
|
Placebo Comparator: Cardiac Diet
2 gm/day salt 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of hospital stay
Time Frame: Hospital admission to time of discharge assessed up to 1 year
|
number of days the patient remains hospitalized
|
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
|
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
Time Frame: time of hospital admission to 30 days after 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
Time Frame: time of hospital admission to 30 days after discharge
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maya Guglin, MD, Rutgers University
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)
January 21, 2026
Primary Completion (Estimated)
November 10, 2027
Study Completion (Estimated)
November 1, 2028
Study Registration Dates
First Submitted
March 11, 2026
First Submitted That Met QC Criteria
April 27, 2026
First Posted (Actual)
May 1, 2026
Study Record Updates
Last Update Posted (Actual)
May 1, 2026
Last Update Submitted That Met QC Criteria
April 27, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro2025001253
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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