Oral Sodium for Acute Heart Failure

(OSPREY-AHF Trial)

Overseen By Jennifer Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Must be taking: Diuretics

Must not be taking: Vasopressin antagonists, Sodium chloride

Disqualifiers: Diabetes insipidus, Malabsorptive disorders, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding oral sodium chloride (table salt) to the treatment of patients hospitalized with acute heart failure can enhance fluid removal and kidney function. Participants will receive either sodium chloride or a placebo (a dummy treatment) alongside their usual diuretics, which help the body eliminate excess fluid. The researchers aim to determine if the salt supplement affects patient outcomes. This trial may suit those admitted to a hospital with severe heart failure and currently receiving a continuous diuretic infusion. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could improve future heart failure treatments.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using sodium chloride tablets or certain other medications like vasopressin antagonists.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that taking oral sodium chloride (table salt) with intravenous diuretics (medicines that help patients urinate) in cases of sudden heart failure is safe. Previous research found no significant difference in hospital stay length when oral sodium chloride was added, suggesting it did not cause additional issues. An independent board monitored safety and side effects, enhancing confidence in its safety.

Overall, research indicates that oral sodium chloride is well-tolerated as part of heart failure treatment. However, as with any treatment, patients should consider their health and consult their doctor before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about oral sodium chloride for acute heart failure because it offers a new approach by directly increasing sodium intake. Unlike traditional treatments that often focus on removing excess fluid through diuretics, this method aims to stabilize sodium levels, which could improve heart function more quickly and effectively. This oral administration is straightforward and could potentially be integrated easily into daily routines, offering a novel way to manage symptoms and improve patient outcomes.

What evidence suggests that oral sodium chloride could be an effective treatment for acute heart failure?

This trial will compare the effects of oral sodium chloride with a placebo in participants with acute heart failure. Research has shown that taking salt tablets alongside water-reducing medications might help individuals with sudden heart failure lose weight and improve kidney function. However, some studies found no major difference between those taking salt tablets and those taking a placebo (a harmless pill with no effect). This uncertainty means the effectiveness of salt tablets for this condition remains unclear. As a new concept, further research is needed to determine its true efficacy. ^{1 2 3 6 7}

Who Is on the Research Team?

Wilson Tang, MD

Principal Investigator

The Cleveland Clinic

Robert A Montgomery, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 with acute decompensated heart failure hospitalized on a cardiology floor, not in ICU. They must have high levels of NT-proBNP and be starting high-dose IV diuretics. Exclusions include very high blood pressure, short hospital stay, certain medications or conditions affecting water balance or sodium levels, severe kidney dysfunction, and recent or upcoming contrast imaging.

Inclusion Criteria

Your NT-proBNP level is higher than 1000 ng/L.

I am admitted to a cardiology unit with worsening heart failure.

I am starting a high-dose water pill infusion.

Exclusion Criteria

I cannot swallow pills or tolerate eating solid foods.

I have not used iodinated contrast material in the last 3 days.

Your blood sodium level is below 120 or above 145.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either oral sodium chloride or placebo three times daily with meals

4 days

Daily monitoring (in-patient)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Oral Sodium Chloride
• Placebo

Trial Overview The study tests if taking oral sodium chloride along with IV diuretics improves weight loss and kidney function in patients with acute heart failure compared to a placebo. It's a controlled trial where participants are randomly assigned to either the salt tablets or dummy pills without knowing which one they're getting.

How Is the Trial Designed?

Group I: Oral Sodium Chloride Active Control 1 Intervention

Subject will be given 2 grams of oral sodium chloride three times daily with meals for approximately 4 days

Group II: Placebo Placebo Group 1 Intervention

Subject will be given a placebo orally three times daily with meals for approximately 4 days

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

The SODIUM-HF trial, involving heart failure patients, demonstrated that reducing dietary sodium intake to less than 100 mmol per day can lead to significant improvements in heart failure symptoms and overall health outcomes.

This international, open-label, randomized controlled trial provides strong evidence supporting sodium reduction as a safe and effective dietary intervention for managing heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced dietary sodium did not reduce clinical events in heart failure. Alvarado, F., Borzak, S.[2022]

In a study of 51 hospitalized patients with severe heart failure, supplying additional sodium chloride effectively corrected hyponatremia, with 98% of patients showing improved symptoms upon discharge.

The treatment was safe, as no cases of heart failure exacerbation or hypernatremia were observed, indicating that additional sodium chloride can be a beneficial intervention in managing hyponatremia in heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical experience of supplying sodium chloride for the treatment of patients with severe heart failure]. He, LX., Sun, LL., Yang, YJ., et al.[2015]

A pilot study involving 50 patients with heart failure with reduced ejection fraction (HFREF) found that a low sodium-potassium enriched salt substitute was safe to use compared to regular salt over a 12-week period, with no significant differences in vital signs or kidney function.

The study also showed a small but significant improvement in exercise capacity (measured by the 6-minute walk distance) in patients using the salt substitute, suggesting potential benefits that warrant further randomized clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of salt substitution with a low sodium-potassium enriched dietary salt in patients with heart failure with reduced ejection fraction: A pilot study. Bistola, V., Arfaras-Melainis, A., Trogkanis, E., et al.[2021]

In a study of 70 hospitalized patients with acute heart failure, the addition of oral sodium chloride (NaCl) during intravenous diuretic therapy did not significantly affect renal function or weight change compared to a placebo, indicating that salt intake may not be crucial in this context.

While there were no significant differences in the primary endpoints, the NaCl group did show a notable reduction in serum sodium and blood urea nitrogen levels, suggesting some biochemical changes, but overall, the study concluded that liberal versus restrictive NaCl intake strategies did not impact the safety and efficacy of diuretic therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral Sodium to Preserve Renal Efficiency in Acute Heart Failure: A Randomized, Placebo-Controlled, Double-Blind Study. Montgomery, RA., Mauch, J., Sankar, P., et al.[2023]

In a pilot study involving 83 heart failure patients, a 12-week trial of 1500-mg sodium meals showed improved quality of life compared to 3000-mg meals, indicating that lower sodium intake may benefit patients' well-being.

Both sodium diets effectively reduced urinary sodium levels without significant adverse effects, suggesting that further research on dietary sodium in heart failure patients is warranted, despite challenges in participant compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low- Versus Moderate-Sodium Diet in Patients With Recent Hospitalization for Heart Failure: The PROHIBIT (Prevent Adverse Outcomes in Heart Failure by Limiting Sodium) Pilot Study. Kalogeropoulos, A., Papadimitriou, L., Georgiopoulou, VV., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37044281/

Oral Sodium to Preserve Renal Efficiency in Acute Heart ... A median of 13 grams of NaCl was given compared to placebo. At 96 hours, there was no significant difference between treatment groups with ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04334668

Oral Sodium to Preserve Renal EfficiencY in Acute Heart ... The use of oral sodium chloride leads to improved effective diuresis (as measured by weight loss) and renal function as compared to placebo.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1071916423001112

Oral Sodium to Preserve Renal Efficiency in Acute Heart ... A median of 13 grams of NaCl was given compared to placebo. At 96 hours, there was no significant difference between treatment groups with respect to the ...

4. uhhospitals.org uhhospitals.org/for-clinicians/articles-and-news/articles/2022/11/one-of-a-kind-clinical-trial-of-sodium-intake-challenges-conventional-wisdom

One of a kind Clinical Trial of Sodium Intake Challenges ... OSPREY-AHF Findings​​ Results from OSPREY-AHF showed no differences in weight or creatinine measurements for patients receiving oral sodium ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04334668/oral-sodium-to-preserve-renal-efficiency-in-acute-heart-failure

Oral Sodium to Preserve Renal EfficiencY in Acute Heart ... Dietary sodium restriction is a common therapeutic intervention in the management of patients hospitalized with decompensated heart failure.

6. nature.com nature.com/articles/s41598-024-58632-4

Positive association between sodium-to-chloride ratio and ... The linear relationship between the Na/Cl ratio and in-hospital mortality in AHF patients indicates a positive association.

7. hsrd.research.va.gov hsrd.research.va.gov/publications/management_briefs/default.cfm?ManagementBriefsMenu=eBrief-no219&eBriefTitle=In-Hospital+Sodium+Intake+for+Acute+Decompensated+Heart+Failure

In-Hospital Sodium Intake for Acute Decompensated Heart ... The one study conducted in the United States found no significant difference in hospital length of stay between oral NaCl with furosemide and furosemide alone. ...