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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 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

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.

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,049 Previous Clinical Trials
1,370,677 Total Patients Enrolled
Robert A Montgomery, MDPrincipal InvestigatorThe Cleveland Clinic
W. H. Wilson Tang, MDPrincipal InvestigatorThe Cleveland Clinic
8 Previous Clinical Trials
11,874 Total Patients Enrolled

Media Library

Oral Sodium Chloride Clinical Trial Eligibility Overview. Trial Name: NCT04334668 — N/A
Volume Overload Research Study Groups: Placebo, Oral Sodium Chloride
Volume Overload Clinical Trial 2023: Oral Sodium Chloride Highlights & Side Effects. Trial Name: NCT04334668 — N/A
Oral Sodium Chloride 2023 Treatment Timeline for Medical Study. Trial Name: NCT04334668 — N/A
~13 spots leftby Oct 2025