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

67 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if giving salt pills to patients with severe heart failure can help them get rid of extra water and improve their kidney function. Normally, these patients are told to avoid salt, but this study is exploring if adding salt can actually make them feel better. The goal is to see if this approach works better than just using water pills alone.

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 oral sodium safe for humans?

Research on sodium intake in heart failure patients suggests that while increased sodium can pose risks, studies have been conducted to assess safety. For example, a study examined the safety of different sodium levels in diets for heart failure patients, and another looked at sodium chloride use in severe heart failure, indicating ongoing evaluation of safety in these contexts. ^{1 2 3 4 5}

How does oral sodium differ from other treatments for acute heart failure?

Oral sodium treatment for acute heart failure is unique because it involves administering sodium directly by mouth, which may help preserve kidney function and aid in fluid removal, unlike traditional methods that often focus on reducing sodium intake. ^{1 3 6 7 8}

Research Team

Wilson Tang, MD

Principal Investigator

The Cleveland Clinic

Robert A Montgomery, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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

I am 18 years old or older.

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Reduced dietary sodium did not reduce clinical events in heart failure. [2022]

2. China pubmed.ncbi.nlm.nih.gov

[Clinical experience of supplying sodium chloride for the treatment of patients with severe heart failure]. [2015]

3. United States 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. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Race and physical activity: cardiovascular and renal response to sodium loading. [2022]

5. England 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Oral Sodium to Preserve Renal Efficiency in Acute Heart Failure: A Randomized, Placebo-Controlled, Double-Blind Study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

A normal sodium diet preserves serum sodium levels during treatment of acute decompensated heart failure: A prospective, blind and randomized trial. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Impact of iatrogenic, excessive, nondietary sodium administration in patients with acute heart failure exacerbation on hospital length of stay. [2013]