An interventional study of Oral Sodium Chloride and Placebo in Volume Overload, sponsored by The Cleveland Clinic. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Basic science
The investigators are proposing a prospective, randomized, double blinded, placebo-controlled single center study evaluating the role of co-administration of oral sodium chloride (NaCl) with intravenous diuretics in patients hospitalized with acute decompensated heart failure. The investigators are approaching this study with the hypothesis that the use of oral sodium chloride leads to improved effective diuresis (as measured by weight loss) and renal function as compared to placebo in patients hospitalized with acute decompensated heart failure undergoing aggressive intravenous diuretic therapy.
Dietary sodium restriction is a common therapeutic intervention in the management of patients hospitalized with decompensated heart failure. This is despite limited supportive data and inconsistent society guidelines.1-3 Randomized clinical trial data has shown that dietary sodium restriction in patients hospitalized with heart failure was not associated with differences in weight, clinical congestion, time to clinical stability but was associated with increased thirst.4 Numerous studies demonstrate that sodium restriction is associated with increased Renin-Angiotensin-Aldosterone System (RAAS) activation as well as increases in inflammatory markers.5,6 These findings challenge of the role of sodium restriction in hospital management of heart failure and have lead to trials that consider a therapeutic role of providing sodium to patients with acute heart failure for its effect in attenuating neurohormonal activation during aggressive diuresis. A central example is the SMAC-HF study from Italy, which showed that in 1771 patients with acute New York Heart Association (NYHA) class IV heart failure, the addition of hypertonic saline (150ml of 1.4%-4.6% NaCl twice a day in addition to diet liberalization led to statistically significant increased urine output and weight loss in addition to reductions in creatinine, length of stay, mortality and readmissions.7 These findings are controversial but similarly favorable results with the use of hypertonic saline in aiding diuresis have been seen in Japan with improved diuresis with continuous hypertonic saline infusions.8 Despite these results, use of sodium chloride supplementation in acute heart failure remains limited. This may be because the practice challenges ingrained clinical practice, but a more likely reason is that the manner of sodium chloride delivery in these trials (hypertonic saline) is often reserved for the Intensive Care Unit (ICU) setting and central venous access for delivery. While small volumes of hypertonic saline are likely safe to be administered in a non-ICU setting, the results would be more broadly applicable and utilized if the manner of sodium supplementation did not require intensive monitoring or central venous access, ie oral supplementation. Therefore, the purpose of the "Oral Sodium to Preserve Renal EfficiencY in Acute Heart Failure" (OSPREY-AHF) is to evaluate the efficacy and safety of oral sodium chloride supplementation compared to placebo in patients with acute decompensated heart failure. While the investigators are specifically interested in sodium chloride and its hypothesized role in attenuating a neurohormonally mediated diuretic resistance commonly seen in patients requiring high dose diuretic therapy, the investigators also intend that by focusing on oral sodium chloride supplementation the investigators may clarify the role of dietary sodium restriction in hospitalized patients with acute heart failure.
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Exclusion Criteria:
Subject will be given 2 grams of oral sodium chloride three times daily with meals for approximately 4 days
Dietary Supplement: Oral Sodium Chloride
Subject will be given a placebo orally three times daily with meals for approximately 4 days
Other: Placebo
Subjects will be randomized to receive 2 grams oral Sodium Chloride three times daily with meals for approximately 4 days
Subjects will be randomized to receive a placebo three times daily with meals for approximately 4 days.
Change in Weight
Measured in kilograms
Time frame: Baseline to 96 hours
Change in Creatinine
Measured in milliequivalents per Liter
Time frame: Baseline to 96 hours
| Milestone | Oral Sodium Chloride | Placebo |
|---|---|---|
| Started | 34 | 33 |
| Completed | 34 | 31 |
| Not completed | 0 | 2 |
Measured in kilograms
| Kilograms | Oral Sodium Chloride | Placebo |
|---|---|---|
| Change in Weight | -3.9 ± 4.3 | -4.6 ± 4.2 |
Measured in milliequivalents per Liter
| mEq/L | Oral Sodium Chloride | Placebo |
|---|---|---|
| Change in Creatinine | 0.038 ± 0.39 | 0.15 ± 0.44 |
Collected over Enrollment to 90 days post enrollment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oral Sodium Chloride | 3/34 (8.8%) | 7/34 (20.6%) | 4/34 (11.8%) |
| Placebo | 3/31 (9.7%) | 7/31 (22.6%) | 4/31 (12.9%) |
| Event | Oral Sodium Chloride | Placebo |
|---|---|---|
| Worsening Renal FunctionRenal and urinary disorders | 0/34 | 1/31 |
| HypokalemiaGeneral disorders | 0/34 | 1/31 |
| ICU transferCardiac disorders | 0/34 | 1/31 |
| ReadmittedGeneral disorders | 0/34 | 1/31 |
| VF arrestCardiac disorders | 0/34 | 1/31 |
| COVID 19 infectionRespiratory, thoracic and mediastinal disorders | 0/34 | 1/31 |
| Respiratory decompensationGeneral disorders | 0/34 | 1/31 |
| ReadmissionGeneral disorders | 0/34 | 1/31 |
| ICU transferGeneral disorders | 0/34 | 1/31 |
| ICUCardiac disorders | 0/34 | 1/31 |
| Event | Oral Sodium Chloride | Placebo |
|---|---|---|
| Gout Flare upGeneral disorders | 0/34 | 1/31 |
| hypokalemiaGeneral disorders | 0/34 | 1/31 |
| Hypokalemia, VF arrestGeneral disorders | 0/34 | 1/31 |
| NauseaGastrointestinal disorders | 0/34 | 1/31 |
| Transferred to ICURespiratory, thoracic and mediastinal disorders | 1/34 | 0/31 |
| HyponatremiaGeneral disorders | 1/34 | 0/31 |
| NauseaGastrointestinal disorders | 1/34 | 0/31 |
| Nausea/VomitingGastrointestinal disorders | 1/34 | 0/31 |
| Age, Categorical(Participants) | Oral Sodium Chloride | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 10 | 20 |
| >=65 years | 24 | 21 | 45 |
| Sex: Female, Male(Participants) | Oral Sodium Chloride | Placebo | Total |
|---|---|---|---|
| Female | 14 | 11 | 25 |
| Male | 20 | 20 | 40 |
| Race (NIH/OMB)(Participants) | Oral Sodium Chloride | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 7 | 2 | 9 |
| White | 27 | 29 | 56 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Oral Sodium Chloride | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 34 | 31 | 65 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Oral Sodium Chloride | Placebo | Total |
|---|---|---|---|
| United States | 34 | 31 | 65 |
| Weight at enrollment(kilograms) | Oral Sodium Chloride | Placebo | Total |
|---|---|---|---|
| Mean | 99 ± 27 | 100 ± 31 | 100 ± 29 |
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