- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07596329
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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Fase
- Fase 3
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: HSS group
|
50 mL of 10% hypertonic sodium chloride (NaCl)
Furosemide 250 mg administered intravenously over 60 minutes once weekly for 2 months.
|
|
Placebo komparator: placebo group
|
Furosemide 250 mg administered intravenously over 60 minutes once weekly for 2 months.
50 mL of 0.9% sodium chloride (NaCl)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants rehospitalized for heart failure
Tidsramme: 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
Tidsramme: 30 days and 60 days
|
Description: Number of deaths from any cause during follow-up.
|
30 days and 60 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Serum creatinine level
Tidsramme: 30 days 60 days
|
Evaluation of serum creatinine levels.
|
30 days 60 days
|
|
Blood urea level
Tidsramme: 30 days 60 days
|
Evaluation of blood urea levels.
|
30 days 60 days
|
|
BNP or NT-proBNP concentration
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kardiovaskulære sykdommer
- Patologiske prosesser
- Mannlige urogenitale sykdommer
- Nyresykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Hjertesykdommer
- Kronisk sykdom
- Sykdomsattributter
- Nyreinsuffisiens
- Patologiske tilstander, tegn og symptomer
- Hjertefeil
- Nyresvikt, kronisk
- Uorganiske kjemikalier
- Klorforbindelser
- Natriumforbindelser
- Klorider
- Saltsyre
- Natriumklorid
Andre studie-ID-numre
- SALT-HF study
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
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