Heart FailureNCT07560592
The Salt Study for Heart Failure
A study testing Normal Salt Diet and Cardiac Diet in people with Heart Failure, run by Maya Guglin, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Normal Salt Diet and Cardiac Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2026to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Above 18 years of age
- Hospitalization due to Heart Failure admitted within 24 hours
Who cannot join
- Concomitant hypertension (blood pressure >150/90 mmHg on admission)
- End stage renal disease (on hemodialysis or peritoneal dialysis
- Cardiogenic shock
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Manisha Bajpai, PhD contact
United States1 site, 1 recruiting
- Recruiting
Robert Wood Johnson Barnabas Hospital - New Brunswick
New Brunswick, New Jersey, 08901
Maya Guglin, MD, 8483915776, maya.guglin@rutgers.edu
Manisha Bajpai, PhD, manisha.bajpai@rutgers.edu
About this study
Official title: 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.
- Conditions
- Heart Failure
- Being tested
- Normal Salt Diet, Cardiac Diet
- Keywords
- Heart failure, Salt diet
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal Salt DietOther
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.
Cardiac DietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Normal Salt Diet | Experimental | 3-4 gm/day salt diet Receives: Other: Normal Salt Diet |
| Cardiac Diet | Placebo comparator | 2 gm/day salt diet Receives: Other: Cardiac Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
number of days the patient remains hospitalized
Measured: 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
Measured: 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.
Measured: 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.
Measured: time of hospital admission to 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start21 Jan 2026
- Primary completion10 Nov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maya Guglin, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maya Guglin, MD, Rutgers, The State University of New Jersey
- Investigators
- Maya Guglin, MD, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560592
- Sponsor's protocol ID
- Pro2025001253
- Status last verified
- Apr 2026
- First submitted
- 11 Mar 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Effect of Low-Sodium and Regular Diets on Heart Failure Outcomes
- ClinicalTrials.gov ID
- NCT07560592
- Acronym / sponsor ID
- Pro2025001253
- Conditions
- Heart Failure
- Keywords
- Heart failure, Salt diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Maya Guglin, MDUniversity, hospital or other
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- 10 Nov 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Normal Salt Diet | Experimental | Other: Normal Salt Diet3-4 gm/day salt diet |
| Cardiac Diet | Placebo comparator | Other: Cardiac Diet2 gm/day salt diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Above 18 years of age
- Hospitalization due to Heart Failure admitted within 24 hours
Key exclusion criteria (3 listed)
- Concomitant hypertension (blood pressure >150/90 mmHg on admission)
- End stage renal disease (on hemodialysis or peritoneal dialysis
- Cardiogenic shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal Salt DietThis 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 | Normal Salt Diet |
| Cardiac DietThis 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. | Other | Cardiac Diet |
Primary outcome
Length of hospital stay
Time frame: Hospital admission to time of discharge assessed up to 1 year
number of days the patient remains hospitalized
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
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
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Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
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Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manisha Bajpai, PhD contact
Maya Guglin, MD principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal Salt Diet and Cardiac Diet in people with Heart Failure, run by Maya Guglin, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maya Guglin, MD (8483915776, maya.guglin@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: Hospital admission to time of discharge assessed up to 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.