Oral Sodium to Preserve Renal EfficiencY in Acute Heart Failure

NCT04334668 | Active Not Recruiting Results

• 1 other identifier: 20-183
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Volume Overload

Outcome Measures

Primary Outcomes (2)

• Change in Weight

  Measured in kilograms

  Baseline to 96 hours

• Change in Creatinine

  Measured in milliequivalents per Liter

  Baseline to 96 hours

Study Arms (2)

Oral Sodium Chloride

ACTIVE COMPARATOR

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

Dietary Supplement: Oral Sodium Chloride

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Placebo OTHER

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

Placebo

Oral Sodium Chloride DIETARY_SUPPLEMENT

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

Oral Sodium Chloride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Use of renal replacement therapy at time of enrollment

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (9)

• Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Oct 15;62(16):e147-239. doi: 10.1016/j.jacc.2013.05.019. Epub 2013 Jun 5. No abstract available.

  PMID: 23747642 BACKGROUND

• Heart Failure Society of America; Lindenfeld J, Albert NM, Boehmer JP, Collins SP, Ezekowitz JA, Givertz MM, Katz SD, Klapholz M, Moser DK, Rogers JG, Starling RC, Stevenson WG, Tang WH, Teerlink JR, Walsh MN. HFSA 2010 Comprehensive Heart Failure Practice Guideline. J Card Fail. 2010 Jun;16(6):e1-194. doi: 10.1016/j.cardfail.2010.04.004.

  PMID: 20610207 BACKGROUND

• McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; ESC Committee for Practice Guidelines. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012 Jul;33(14):1787-847. doi: 10.1093/eurheartj/ehs104. Epub 2012 May 19. No abstract available.

  PMID: 22611136 BACKGROUND

• Aliti GB, Rabelo ER, Clausell N, Rohde LE, Biolo A, Beck-da-Silva L. Aggressive fluid and sodium restriction in acute decompensated heart failure: a randomized clinical trial. JAMA Intern Med. 2013 Jun 24;173(12):1058-64. doi: 10.1001/jamainternmed.2013.552.

  PMID: 23689381 BACKGROUND

• Graudal NA, Hubeck-Graudal T, Jurgens G. Effects of low-sodium diet vs. high-sodium diet on blood pressure, renin, aldosterone, catecholamines, cholesterol, and triglyceride (Cochrane Review). Am J Hypertens. 2012 Jan;25(1):1-15. doi: 10.1038/ajh.2011.210. Epub 2011 Nov 9.

  PMID: 22068710 BACKGROUND

• Parrinello G, Di Pasquale P, Licata G, Torres D, Giammanco M, Fasullo S, Mezzero M, Paterna S. Long-term effects of dietary sodium intake on cytokines and neurohormonal activation in patients with recently compensated congestive heart failure. J Card Fail. 2009 Dec;15(10):864-73. doi: 10.1016/j.cardfail.2009.06.002.

  PMID: 19944363 BACKGROUND

• Paterna S, Fasullo S, Parrinello G, Cannizzaro S, Basile I, Vitrano G, Terrazzino G, Maringhini G, Ganci F, Scalzo S, Sarullo FM, Cice G, Di Pasquale P. Short-term effects of hypertonic saline solution in acute heart failure and long-term effects of a moderate sodium restriction in patients with compensated heart failure with New York Heart Association class III (Class C) (SMAC-HF Study). Am J Med Sci. 2011 Jul;342(1):27-37. doi: 10.1097/MAJ.0b013e31820f10ad.

  PMID: 21701268 BACKGROUND

• Okuhara Y, Hirotani S, Naito Y, Nakabo A, Iwasaku T, Eguchi A, Morisawa D, Ando T, Sawada H, Manabe E, Masuyama T. Intravenous salt supplementation with low-dose furosemide for treatment of acute decompensated heart failure. J Card Fail. 2014 May;20(5):295-301. doi: 10.1016/j.cardfail.2014.01.012. Epub 2014 Jan 22.

  PMID: 24462960 BACKGROUND

• Montgomery RA, Mauch J, Sankar P, Martyn T, Engelman T, Martens P, Faulkenberg K, Menon V, Estep JD, Tang WHW. Oral Sodium to Preserve Renal Efficiency in Acute Heart Failure: A Randomized, Placebo-Controlled, Double-Blind Study. J Card Fail. 2023 Jul;29(7):986-996. doi: 10.1016/j.cardfail.2023.03.018. Epub 2023 Apr 11.

  PMID: 37044281 DERIVED

MeSH Terms

Conditions

Edema

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Limitations: single center trial, small sample size, heterogeneous baseline characteristics \& degree of congestion, only powered for short term effects of NaCl supplementation, not powered for noninferiority analysis for change in weight, extra NaCl not continued after IV diuresis stopped, underpowered to fully assess significance of NaCl on safety, only spot urine collected (no 24-hour urine) \& only 48 patients provided samples for serum biomarker analysis.

Results Point of Contact

• Title: Dr. W. H. Wilson Tang
• Organization: Cleveland Clinic

tangw@ccf.org

216-444-2121

Study Officials

• W. H. Wilson Tang, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Robert A Montgomery, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: This is a double blind study. Subjects will be randomized to Sodium Chloride tablets and Placebos and picked up from pharmacy.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Staff Cardovascular & Metabolic Sciences and Cardiovascular Medicine, The Cleveland Clinic

Model Details: Heart Failure patients hospitalized for diuresis

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 6, 2020
• Study Start: May 20, 2020
• Primary Completion: June 1, 2022
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 20, 2026
• Results First Posted: March 12, 2024

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)