Outpatient Hypertonic Saline and Loop Diuretic Combination Therapy in Cardiorenal

Официальное название

Outpatient Hypertonic Saline and Loop Diuretic Combination Therapy in Cardiorenal Syndrome: The SALT-HF Randomized Double-Blind Trial

Обзор

Congestive heart failure (CHF) remains a major cause of morbidity, rehospitalization, and mortality worldwide, particularly among elderly and polymorbid patients. Systemic congestion is its most characteristic clinical manifestation and the leading cause of hospitalization for acute heart failure. Standard treatment relies on loop diuretics, primarily furosemide, to reduce fluid overload and alleviate congestive symptoms. However, in clinical practice, many patients exhibit an inadequate diuretic response or resistance to furosemide, particularly in the context of cardiorenal syndrome (CRS), where cardiac and renal dysfunction mutually exacerbate each other. This profile, frequently observed in advanced stages of heart failure, significantly limits the effectiveness of guideline-directed medical therapies (GDMTs), particularly SGLT2 inhibitors, mineralocorticoid receptor antagonists, and angiotensin-converting enzyme (ACE) inhibitors, whose use is often restricted by hypotension, hyperkalemia, or impaired renal function. Thus, in this subgroup of patients, conventional pharmacological approaches encounter a therapeutic barrier, necessitating the search for alternative or complementary strategies targeting sodium and water depletion without compromising renal perfusion. In this context, the combined administration of hypertonic saline (HS) and furosemide has been proposed as a pathophysiologically sound approach to break the vicious cycle of cardiorenal syndrome. Hypertonic saline solution (HSS) acts by restoring effective intravascular volume, improving renal perfusion, and promoting more efficient natriuresis through better furosemide delivery to the distal nephron. Pioneering studies by Paterna et al. showed that the concomitant administration of HSS (1.4-3% NaCl, 150-250 mL) and intravenous furosemide increased diuresis, improved the hemodynamic profile, and reduced the length of hospital stay and readmission rates without deterioration of renal function.

Вмешательства

• Препарат Hypertonic sodium chloride 10%
  50 mL of 10% hypertonic sodium chloride (NaCl)
• Препарат Sodium Chloride 0.9%
  50 mL of 0.9% sodium chloride (NaCl)
• Препарат Furosemide intravenous solution
  Furosemide 250 mg administered intravenously over 60 minutes once weekly for 2 months.

Первичные конечные точки

• Number of participants rehospitalized for heart failure [Срок оценки: 30 days and 60 days]
• All-cause mortality [Срок оценки: 30 days and 60 days]

Вторичные конечные точки (4)

• Serum creatinine level [Срок оценки: 30 days 60 days]
• Blood urea level [Срок оценки: 30 days 60 days]
• BNP or NT-proBNP concentration [Срок оценки: 30days 60 days]
• Quality of life and patient satisfaction score assessed using a Likert scale [Срок оценки: 30 days and 60 days]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Chronic renal insufficiency (serum creatinine > 150 µg/ml)
• Diagnosis of heart failure (preserved or reduced LVEF)
• Signed informed consent

Критерии исключения

• Severe hyponatremia (<130 mmol/L) or hypernatremia (>150 mmol/L),
• History of allergic reaction to HSS or furosemide
• Shock or hemodynamic instability
• Pregnancy or breastfeeding
• Chronic dialysis treatment
• Patient refusal or withdrawal of consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07596329 · SALT-HF study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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