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NCT Number: NCT04533997

Hypertonic Saline Therapy in Ambulatory Heart Failure Unit.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previous heart failure diagnosis (according to current European Guidelines)
  • Stable treatment in the previous 4 weeks (except diuretic).
  • Home oral treatment of ≥80 mg of furosemide/day or equivalent (40 mg furosemide = 20 mg of torasemide).
  • Transthoracic echocardiogram performed in the last year.
  • Congestive signs.The presence of two of the following congestion criteria will be required: jugular pressure> 10 cm, lower limb edema, ascites, or pleural effusion
  • Elevation of natriuretic peptides (NTproBNP> 1000 pg / mL or B-type natriuretic peptide> 250 pg / ml) performed in a previous period of no more than 24 hours.
  • Need for intravenous diuretic therapy to relieve congestion according to the responsible physician.

Exclusion criteria

  • Hospital admission criteria in the opinion of the responsible physician.
  • Systolic blood pressure <90 mmHg or> 180 mmHg.
  • Heart rate> 150 bpm or < 40 bpm
  • Basal oxygen saturation less than 90%.
  • Cardiogenic shock.
  • Acute Pulmonary Edema.
  • Clinically significant arrhythmia.
  • Acute myocardial ischemia.
  • Patients in hemodialysis or peritoneal dialysis program.
  • Serum sodium <125 milliequivalent / L or> 145 milliequivalent / L.
  • Serum potassium < 3.5 milliequivalent/ L.
  • Hemoglobin < 9 g / dL
  • Acute coronary syndrome or cardiological procedure in the previous 2 weeks.
  • Severe uncorrected valve disease except tricuspid regurgitation.
  • Moderate or severe dementia, active delirium or psychiatric problems.
  • Patients in whom cardiac surgery or device implantation is planned in the following 30 days.
  • Pregnancy or breastfeeding.
  • Inability to give informed consent in the absence of a legal officer.
  • Patients on tolvaptan.
  • Inability to collect the urine.

Treatment and study plan

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%

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

Primary outcomes

  1. Diuresis volume (ml)

    Time frame: 3 hours after treatment

    Total diuresis volume after 3 hours of therapy administration

Secondary outcomes

  1. Weight difference (kg)

    Time frame: 3 hours

    Difference of weight 3 hours after the start of treatment

  2. Weight difference (kg)

    Time frame: 7 days

    Difference of weight 7 days after the start of treatment

  3. Change in composite congestion score

    Time frame: 7 days

    Composite of orthopnoea (0-3), jugular venous distension (0-3), lower limb oedema (0-3). Higher score: worse congestion

  4. Change in Inferior cava vein diameter (mm)

    Time frame: 7 days

    Change in Inferior cava vein diameter (mm) 7 days after treatment

  5. Change in Number of fields with more than 3 B-lines in lung ultrasound

    Time frame: 7 days

    Change in Number of fields with more than 3 B-lines in lung ultrasound 7 days after treatment

  6. Change in New York Heart Association and Visual Analogue Scale

    Time frame: 7 days

    Visual Analogue Scale from 0 (worst state of health) to 100 (best state of health)

  7. Change in NTproBNP and Cancer Antigen 125 levels

    Time frame: 7 days

    Change in NTproBNP and Cancer Antigen 125 levels 7 days after treatment

  8. Change in Hemoconcentration Parameters

    Time frame: 7 days

    Hematocrit, Albumin and total Proteins

  9. Change in Urinary Sodium

    Time frame: 7 days

    Change in Urinary Sodium measured in a spot urinary sample

  10. Adverse Events

    Time frame: 7 days

    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)

  11. Adverse Events

    Time frame: 30 days

    Need of new intravenous diuretic (outpatient clinic or emergency department). Heart Failure hospitalization. Cardiovascular mortality. All-Cause mortality or hospitalization.

Sponsors and collaborators

Lead sponsor

Puerta de Hierro University Hospital

Other

Collaborators

  • Instituto de Salud Carlos III
  • Spanish Society of Cardiology

Registry information

Official study title

Efficacy and Safety of Ambulatory Hypertonic Saline Therapy in Outpatient Heart Failure Units.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 1, 2020
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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