What side effects are associated with this type of intervention?

Treatments for volume overload, such as diuretics, commonly cause side effects including electrolyte imbalances (hypokalemia or hyperkalemia), dehydration, hypotension, and renal dysfunction. Loop diuretics can additionally cause ototoxicity, while thiazide diuretics may lead to hyperglycemia and hyperuricemia. The trial involving oral sodium chloride aims to enhance diuretic effectiveness, potentially impacting these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for volume overload, primarily focusing on diuretics such as furosemide, bumetanide, and torsemide, which are loop diuretics commonly used to manage fluid retention in conditions like heart failure. Additionally, thiazide diuretics like hydrochlorothiazide and potassium-sparing diuretics like spironolactone are also approved. These medications help reduce fluid buildup by increasing urine output. The trial studying oral sodium chloride aims to enhance the effectiveness of these diuretics by improving fluid balance, a concept that aligns with the goal of optimizing diuretic therapy in volume overload management.

What other types of research exist?

Promising novel alternatives to oral sodium chloride for volume overload patients include Sodium-Glucose Cotransporter 2 (SGLT2) inhibitors, which have shown benefits in fluid balance and diuretic resistance, and long-term albumin administration, which has demonstrated improved survival and fluid management in cirrhosis patients. Additionally, the use of hypertonic saline inhalation has been effective in managing fluid balance in cystic fibrosis and may offer insights for broader applications.

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Oral Sodium for Acute Heart Failure (OSPREY-AHF Trial)

N/A

Waitlist Available

Led By Robert A Montgomery, MD

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years old

Admitted to cardiology floor (non-ICU) with primary diagnosis of decompensated heart failure

Must not have

Inability to tolerate oral diet or swallow pills

Presence of malabsorptive gastrointestinal disorder (Crohn's disease, short gut syndrome)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 96 hours

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include increased blood pressure due to extra sodium intake, fluid retention leading to swelling in limbs or lungs (pulmonary edema), potential worsening of heart failure symptoms, and possible negative impacts on kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

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I am starting a high-dose water pill infusion.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot swallow pills or tolerate eating solid foods.

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I have a condition like Crohn's disease that affects how my body absorbs nutrients.

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I am not using any IV drugs to help my heart pump or control my blood pressure.

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I am on dialysis.

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I have been diagnosed with diabetes insipidus.

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I am taking medication that blocks vasopressin.

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I am currently taking sodium chloride tablets.

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My kidney function is severely reduced.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 96 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 96 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 96 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Creatinine

Change in Weight

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Oral Sodium ChlorideActive Control1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for volume overload involve the use of diuretics, which promote the excretion of sodium and water through the kidneys, thereby reducing fluid volume in the body. This is crucial for patients with conditions like heart failure or kidney disease, as it helps alleviate symptoms such as edema and hypertension. The trial involving oral sodium chloride aims to enhance the effectiveness of diuretics by ensuring adequate sodium levels, which can improve diuretic response and fluid balance, ultimately leading to better patient outcomes.

The effect of Ringer solution induced extracellular volume expansion on kidney function.Effects of Water Loading on Observed and Predicted Plasma Sodium, and Fluid and Urine Cation Excretion in Healthy Individuals.Perioperative fluid management and postoperative hyponatremia in children.