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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
| Spanish Society of Cardiology | OTHER |
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The purpose of this study is to compare intravenous furosemide (125 to 250 mg), isolated or in combination with hypertonic saline solution (2.6% to 3.4%) in the outpatient heart failure patient. The hypothesis is that the combination therapy will increase the diuresis volume at 3 hours and improve congestion parameters at 7 days.
This is a randomized, double-blind, multicenter study of all consecutive patients with decompensated heart failure and signs of volume overload who do not require hospital admission but require intravenous diuretic for relief of congestion.
Patients meeting the inclusion criteria, with prior informed consent, will be randomized to treatment with furosemide with hypertonic saline versus isolated furosemide (control group).
Complete clinical evaluation, echocardiography, and blood and urinary tests will be performed before the treatment. After 3 hours, diuresis volume, weight and urinary parameters will be evaluated. Efficacy and safety visits will be performed at 7 and 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous furosemide | Active Comparator |
| |
| Hypertonic saline solution plus intravenous furosemide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypertonic saline solution plus intravenous furosemide | Drug | Intravenous 60-minutes of hypertonic saline therapy plus furosemide: Furosemide: 125 mg if home oral furosemide ≤160 mg, 250 mg if home oral furosemide > 160 mg Hypertonic saline solution: Na+ 125-134: 3.4%, Na+ 135-145: 2.6% |
| Measure | Description | Time Frame |
|---|---|---|
| Diuresis volume (ml) | Total diuresis volume after 3 hours of therapy administration | 3 hours after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Weight difference (kg) | Difference of weight 3 hours after the start of treatment | 3 hours |
| Weight difference (kg) | Difference of weight 7 days after the start of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marta Cobo Marcos, MD | Hospital Universitario Puerta de Hierro. Madrid. Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Puerta de Hierro | Majadahonda | Madrid | 28222 | Spain | ||
| Hospital Universitario Rey Juan Carlos |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D012462 | Saline Solution, Hypertonic |
| ID | Term |
|---|---|
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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Randomization 1:1 to treatment with a 1-hour infusion of IV furosemide plus HSS (2.6-3.4% NaCl depending on plasmatic sodium levels) versus a 1-hour infusion of IV furosemide at the same dose (125-250 mg, depending on basal loop diuretic dose).
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Based on an automated online system, blinded to the physicians who evaluated the patient.
Randomization was performed by a trained nurse in a separate room
|
| Intravenous furosemide | Drug | Intravenous 60-minutes infusion of furosemide: 125 mg if home oral furosemide ≤ 160 mg, 250 mg if home oral furosemide > 160 mg |
|
| 7 days |
| Change in composite congestion score | Composite of orthopnoea (0-3), jugular venous distension (0-3), lower limb oedema (0-3). Higher score: worse congestion | 7 days |
| Change in Inferior cava vein diameter (mm) | Change in Inferior cava vein diameter (mm) 7 days after treatment | 7 days |
| Change in Number of fields with more than 3 B-lines in lung ultrasound | Change in Number of fields with more than 3 B-lines in lung ultrasound 7 days after treatment | 7 days |
| Change in New York Heart Association and Visual Analogue Scale | Visual Analogue Scale from 0 (worst state of health) to 100 (best state of health) | 7 days |
| Change in NTproBNP and Cancer Antigen 125 levels | Change in NTproBNP and Cancer Antigen 125 levels 7 days after treatment | 7 days |
| Change in Hemoconcentration Parameters | Hematocrit, Albumin and total Proteins | 7 days |
| Change in Urinary Sodium | Change in Urinary Sodium measured in a spot urinary sample | 7 days |
| Adverse Events | Need of new intravenous diuretic (outpatient clinic or emergency department). Heart Failure hospitalization. Cardiovascular mortality. All-Cause mortality or hospitalization. Worsening of kidney function: defined as an increase in creatinine ≥ 0.3 mg / dl. Electrolyte abnormalities defined as hypokalemia (K+ less than 3.5 milliequivalent / L) or hyperkalemia (K+ greater than 5.5 milliequivalent /L) | 7 days |
| Adverse Events | Need of new intravenous diuretic (outpatient clinic or emergency department). Heart Failure hospitalization. Cardiovascular mortality. All-Cause mortality or hospitalization. | 30 days |
| Móstoles |
| Madrid |
| 28933 |
| Spain |
| Hospital de la Santa Creu i Santa Pau (Fundación Privada Hospital de la Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Hospital Universitari de Bellvitge | Barcelona | 08907 | Spain |
| Hospital San Pedro de Alcántara | Cáceres | 10003 | Spain |
| Hospital Universitario Arnau de Vilanova | Lleida | 25198 | Spain |
| Hospital Universitario La Princesa | Madrid | 28006 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Clinico Universitario San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario Doce de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Hospital Clínico Universitario Lozano de Blesa | Zaragoza | 50009 | Spain |