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Oral Sodium to Preserve Renal EfficiencY in Acute Heart Failure

Oral Sodium to Preserve Renal EfficiencY in Acute Heart Failure (OSPREY-AHF)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04334668
Acronym
OSPREY-AHF
Enrollment
67
Registered
2020-04-06
Start date
2020-05-20
Completion date
2026-12-31
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Volume Overload

Brief summary

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.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTOral Sodium Chloride

Subjects will be randomized to receive 2 grams oral Sodium Chloride three times daily with meals for approximately 4 days

OTHERPlacebo

Subjects will be randomized to receive a placebo three times daily with meals for approximately 4 days.

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)

Masking description

This is a double blind study. Subjects will be randomized to Sodium Chloride tablets and Placebos and picked up from pharmacy.

Intervention model description

Heart Failure patients hospitalized for diuresis

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥ 18 years old AND * Admitted to cardiology floor (non-ICU) with primary diagnosis of decompensated heart failure AND * NT-proBNP \>1000 ng/L AND * Initiation of continuous furosemide infusion at a rate of 10 mg/hr or higher

Exclusion criteria

* Serum sodium (Na+) level less than 120 or greater than 145. * Average Systolic Blood Pressure \>180 mmHg or Diastolic Blood Pressure \>100 mmHg over past 24 hours. * Anticipated length of stay less than 72 hours. * Use of vasopressin antagonist * Current use of sodium chloride tablets * Active diagnosis of diabetes insipidus * Inability to tolerate oral diet or swallow pills * Presence of malabsorptive gastrointestinal disorder (Crohn's disease, short gut syndrome) * The use of iodinated radiocontrast material in the past 72 hours or anticipated use of intravenous contrast during the current hospitalization * Admission with intention to transplant or implant permanent Ventricular Assistive Device * Use of intravenous inotropes, vasopressors or vasodilators at enrollment * A baseline estimated glomerular filtration rate \<15 mL/min/1.73m² according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula at the moment of inclusion * Use of renal replacement therapy at time of enrollment

Design outcomes

Primary

MeasureTime frameDescription
Change in WeightBaseline to 96 hoursMeasured in kilograms
Change in CreatinineBaseline to 96 hoursMeasured in milliequivalents per Liter

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORW. H. Wilson Tang, MD

The Cleveland Clinic

Participant flow

Participants by arm

ArmCount
Oral Sodium Chloride
Subject will be given 2 grams of oral sodium chloride three times daily with meals for approximately 4 days Oral Sodium Chloride: Subjects will be randomized to receive 2 grams oral Sodium Chloride three times daily with meals for approximately 4 days
34
Placebo
Subject will be given a placebo orally three times daily with meals for approximately 4 days Placebo: Subjects will be randomized to receive a placebo three times daily with meals for approximately 4 days.
31
Total65

Baseline characteristics

CharacteristicOral Sodium ChloridePlaceboTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
24 Participants21 Participants45 Participants
Age, Categorical
Between 18 and 65 years
10 Participants10 Participants20 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
34 Participants31 Participants65 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
7 Participants2 Participants9 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
27 Participants29 Participants56 Participants
Region of Enrollment
United States
34 participants31 participants65 participants
Sex: Female, Male
Female
14 Participants11 Participants25 Participants
Sex: Female, Male
Male
20 Participants20 Participants40 Participants
Weight at enrollment99 kilograms
STANDARD_DEVIATION 27
100 kilograms
STANDARD_DEVIATION 31
100 kilograms
STANDARD_DEVIATION 29

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
3 / 343 / 31
other
Total, other adverse events
4 / 344 / 31
serious
Total, serious adverse events
7 / 347 / 31

Outcome results

Primary

Change in Creatinine

Measured in milliequivalents per Liter

Time frame: Baseline to 96 hours

ArmMeasureValue (MEAN)Dispersion
Oral Sodium ChlorideChange in Creatinine0.038 mEq/LStandard Deviation 0.39
PlaceboChange in Creatinine0.15 mEq/LStandard Deviation 0.44
Primary

Change in Weight

Measured in kilograms

Time frame: Baseline to 96 hours

ArmMeasureValue (MEAN)Dispersion
Oral Sodium ChlorideChange in Weight-3.9 KilogramsStandard Deviation 4.3
PlaceboChange in Weight-4.6 KilogramsStandard Deviation 4.2

Source: ClinicalTrials.gov · Data processed: Jul 14, 2026