Outpatient Hypertonic Saline and Loop Diuretic Combination Therapy in Cardiorenal (SALT-HF)
Outpatient Hypertonic Saline and Loop Diuretic Combination Therapy in Cardiorenal Syndrome: The SALT-HF Randomized Double-Blind Trial
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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- フェーズ 3
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age ≥ 18 years
- Chronic renal insufficiency (serum creatinine > 150 µg/ml)
- Diagnosis of heart failure (preserved or reduced LVEF)
- Signed informed consent
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:HSS group
|
50 mL of 10% hypertonic sodium chloride (NaCl)
Furosemide 250 mg administered intravenously over 60 minutes once weekly for 2 months.
|
|
プラセボコンパレーター:placebo group
|
Furosemide 250 mg administered intravenously over 60 minutes once weekly for 2 months.
50 mL of 0.9% sodium chloride (NaCl)
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of participants rehospitalized for heart failure
時間枠:30 days and 60 days
|
Description: Number of participants requiring rehospitalization for heart failure during follow-up.
|
30 days and 60 days
|
|
All-cause mortality
時間枠:30 days and 60 days
|
Description: Number of deaths from any cause during follow-up.
|
30 days and 60 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Serum creatinine level
時間枠:30 days 60 days
|
Evaluation of serum creatinine levels.
|
30 days 60 days
|
|
Blood urea level
時間枠:30 days 60 days
|
Evaluation of blood urea levels.
|
30 days 60 days
|
|
BNP or NT-proBNP concentration
時間枠:30days 60 days
|
Evaluation of BNP or NT-proBNP levels.
|
30days 60 days
|
|
Quality of life and patient satisfaction score assessed using a Likert scale
時間枠:30 days and 60 days
|
Description: Assessment of quality of life and patient satisfaction using a 5-point Likert scale ranging from 1 to 5, where: 1 = very dissatisfied/very poor quality of life 5 = very satisfied/excellent quality of life Higher scores indicate better patient satisfaction and quality of life. |
30 days and 60 days
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- SALT-HF study
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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