Hypertonic Saline Therapy in Ambulatory Heart Failure Unit.

Sponsor

Puerta de Hierro University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04533997

Collaborator

Instituto de Salud Carlos III (Other), Spanish Society of Cardiology (Other)

168

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare intravenous furosemide (125 to 250 mg), isolated or in combination with hypertonic saline solution (2.4% to 3.6%) 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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Drug: Hypertonic saline solution plus intravenous furosemide Drug: Intravenous furosemide	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

168 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intravenous furosemide	Drug: Intravenous furosemide Intravenous 60-minutes infusion of furosemide: 125 mg if home oral furosemide < 160 mg, 250 mg if home oral furosemide ≥ 160 mg
Experimental: Hypertonic saline solution plus intravenous furosemide	Drug: Hypertonic saline solution plus intravenous furosemide 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: 3.6%, Na+ 135-145: 2.4%

Arm

Intervention/Treatment

Active Comparator: Intravenous furosemide

Drug: Intravenous furosemide

Intravenous 60-minutes infusion of furosemide: 125 mg if home oral furosemide < 160 mg, 250 mg if home oral furosemide ≥ 160 mg

Experimental: Hypertonic saline solution plus intravenous furosemide

Drug: Hypertonic saline solution plus intravenous furosemide

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: 3.6%, Na+ 135-145: 2.4%

Outcome Measures

Primary Outcome Measures

Diuresis volume (ml) [3 hours after treatment]
Total diuresis volume after 3 hours of therapy administration

Secondary Outcome Measures

Weight difference (kg) [3 hours]
Weight difference (kg) [7 days]
Change in EVEREST congestion score [7 days]
Composite of dyspnoea (0-3), orthopnoea (0-3), fatigue (0-3), jugular venous distension (0-3), fatigue (0-3), rales (0-3), oedema (0-3). Higher score: worse congestion
Change in Inferior cava vein diameter (mm) [7 days]
Change in Number of B-lines in lung ultrasound [7 days]
Change in New York Heart Association [7 days]
Change in NTproBNP and Cancer Antigen 125 levels [7 days]
Change in Hemoconcentration Parameters [7 days]
Hematocrit, Albumin and total Proteins
Change in Urinary Sodium [7 days]
Change in Urinary Sodium measured in a spot urinary sample
Adverse Events [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)
Adverse Events [30 days]
Need of new intravenous diuretic (outpatient clinic or emergency department). Heart Failure hospitalization. Cardiovascular mortality. All-Cause mortality or hospitalization.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.
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 4 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid	Spain	28222
2	Hospital Universitario Rey Juan Carlos	Móstoles	Madrid	Spain	28933
3	Hospital de la Santa Creu i Santa Pau (Fundación Privada Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08041
4	Hospital Universitari de Bellvitge	Barcelona		Spain	08907
5	Hospital San Pedro de Alcántara	Cáceres		Spain	10003
6	Hospital Universitario Arnau de Vilanova	Lérida		Spain	25198
7	Hospital Universitario La Princesa	Madrid		Spain	28006
8	Hospital Universitario Ramón y Cajal	Madrid		Spain	28034
9	Hospital Clinico Universitario San Carlos	Madrid		Spain	28040
10	Hospital Universitario Doce de Octubre	Madrid		Spain	28041
11	Hospital Universitario Virgen de la Victoria	Málaga		Spain	29010
12	Hospital Clinico Universitario de Valencia	Valencia		Spain	46010
13	Hospital General Universitario de Valencia	Valencia		Spain	46014
14	Hospital Clínico Universitario Lozano de Blesa	Zaragoza		Spain	50009

Sponsors and Collaborators

Puerta de Hierro University Hospital
Instituto de Salud Carlos III
Spanish Society of Cardiology

Investigators

Principal Investigator: Marta Cobo Marcos, MD, Hospital Universitario Puerta de Hierro. Madrid. Spain

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marta Cobo Marcos, Cardiologist, Puerta de Hierro University Hospital

ClinicalTrials.gov Identifier:

NCT04533997

Other Study ID Numbers:

SSH-IC

First Posted:

Sep 1, 2020

Last Update Posted:

Apr 19, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Marta Cobo Marcos, Cardiologist, Puerta de Hierro University Hospital

Hypertonic Saline Solution

Outpatient Heart Failure

Additional relevant MeSH terms:

Heart Failure

Furosemide

Study Results

No Results Posted as of Apr 19, 2022