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Hypertonic Saline Therapy in Ambulatory Heart Failure Unit.

Primary Purpose

Heart Failure

Status

Recruiting

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

Hypertonic saline solution plus intravenous furosemide

Intravenous furosemide

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Hypertonic Saline Solution, Outpatient Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Hospital Universitario Puerta de HierroRecruiting
Hospital Universitario Rey Juan CarlosRecruiting
Hospital de la Santa Creu i Santa Pau (Fundación Privada Hospital de la Santa Creu i Sant PauRecruiting
Hospital Universitari de BellvitgeRecruiting
Hospital San Pedro de AlcántaraRecruiting
Hospital Universitario Arnau de Vilanova
Hospital Universitario La Princesa
Hospital Universitario Ramón y Cajal
Hospital Clinico Universitario San CarlosRecruiting
Hospital Universitario Doce de OctubreRecruiting
Hospital Universitario Virgen de la Victoria
Hospital Clinico Universitario de ValenciaRecruiting
Hospital General Universitario de Valencia
Hospital Clínico Universitario Lozano de BlesaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intravenous furosemide

Hypertonic saline solution plus intravenous furosemide

Arm Description

Outcomes

Primary Outcome Measures

Diuresis volume (ml)

Total diuresis volume after 3 hours of therapy administration

Secondary Outcome Measures

Weight difference (kg)

Change in EVEREST congestion score

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)

Change in Number of B-lines in lung ultrasound

Change in New York Heart Association

Change in NTproBNP and Cancer Antigen 125 levels

Change in Hemoconcentration Parameters

Hematocrit, Albumin and total Proteins

Change in Urinary Sodium

Change in Urinary Sodium measured in a spot urinary sample

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)

Adverse Events

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

Full Information

NCT ID

NCT04533997

First Posted

August 23, 2020

Last Updated

April 18, 2022

Sponsor

Puerta de Hierro University Hospital

Collaborators

Instituto de Salud Carlos III, Spanish Society of Cardiology

1. Study Identification

Unique Protocol Identification Number

NCT04533997

Brief Title

Hypertonic Saline Therapy in Ambulatory Heart Failure Unit.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2021 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Puerta de Hierro University Hospital

Collaborators

Instituto de Salud Carlos III, Spanish Society of Cardiology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

Hypertonic Saline Solution, Outpatient Heart Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intravenous furosemide

Arm Type

Active Comparator

Arm Title

Hypertonic saline solution plus intravenous furosemide

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Hypertonic saline solution plus intravenous furosemide

Intervention Description

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%

Intervention Type

Drug

Intervention Name(s)

Intravenous furosemide

Intervention Description

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

Primary Outcome Measure Information:

Title

Diuresis volume (ml)

Description

Total diuresis volume after 3 hours of therapy administration

Time Frame

3 hours after treatment

Secondary Outcome Measure Information:

Title

Weight difference (kg)

Time Frame

3 hours

Title

Weight difference (kg)

Time Frame

7 days

Title

Change in EVEREST congestion score

Description

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

Time Frame

7 days

Title

Change in Inferior cava vein diameter (mm)

Time Frame

7 days

Title

Change in Number of B-lines in lung ultrasound

Time Frame

7 days

Title

Change in New York Heart Association

Time Frame

7 days

Title

Change in NTproBNP and Cancer Antigen 125 levels

Time Frame

7 days

Title

Change in Hemoconcentration Parameters

Description

Hematocrit, Albumin and total Proteins

Time Frame

7 days

Title

Change in Urinary Sodium

Description

Change in Urinary Sodium measured in a spot urinary sample

Time Frame

7 days

Title

Adverse Events

Description

Time Frame

7 days

Title

Adverse Events

Description

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

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marta Cobo Marcos, MD

Phone

0034911917747

martacobomarcos@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marta Cobo Marcos, MD

Organizational Affiliation

Hospital Universitario Puerta de Hierro. Madrid. Spain

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitario Puerta de Hierro

City

Majadahonda

State/Province

Madrid

ZIP/Postal Code

28222

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marta Cobo Marcos, MD

Phone

0034676743454

martacobomarcos@hotmail.com

Facility Name

Hospital Universitario Rey Juan Carlos

City

Móstoles

State/Province

Madrid

ZIP/Postal Code

28933

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elvira Barrios Garrido-Lestache

First Name & Middle Initial & Last Name & Degree

Elvira Barrios Garrido-Lestache

Facility Name

Hospital de la Santa Creu i Santa Pau (Fundación Privada Hospital de la Santa Creu i Sant Pau

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Isabel Zegri-Reiriz, PhD

First Name & Middle Initial & Last Name & Degree

Isabel Zegri-Reiriz

Facility Name

Hospital Universitari de Bellvitge

City

Barcelona

ZIP/Postal Code

08907

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Santiago Jiménez Marrero

First Name & Middle Initial & Last Name & Degree

Santiago Jiménez Marrero

Facility Name

Hospital San Pedro de Alcántara

City

Cáceres

ZIP/Postal Code

10003

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carolina Ortiz Cortés

First Name & Middle Initial & Last Name & Degree

Carolina Ortiz Cortés

Facility Name

Hospital Universitario Arnau de Vilanova

City

Lérida

ZIP/Postal Code

25198

Country

Spain

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jose Luis Morales-Rull

First Name & Middle Initial & Last Name & Degree

Jose Luis Morales-Rull

Facility Name

Hospital Universitario La Princesa

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pablo Díez Villanueva

First Name & Middle Initial & Last Name & Degree

Pablo Díez Villanueva

First Name & Middle Initial & Last Name & Degree

Fernando Alfonso Manterola

Facility Name

Hospital Universitario Ramón y Cajal

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Susana del Prado Díaz

First Name & Middle Initial & Last Name & Degree

Susana del Prado Díaz

Facility Name

Hospital Clinico Universitario San Carlos

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alejandra Restrepo Córdoba

First Name & Middle Initial & Last Name & Degree

Alejandra Restrepo Córdoba

Facility Name

Hospital Universitario Doce de Octubre

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Javier De Juan Bagudá

First Name & Middle Initial & Last Name & Degree

Javier De Juan Bagudá

Facility Name

Hospital Universitario Virgen de la Victoria

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jose Manuel García Pinilla

First Name & Middle Initial & Last Name & Degree

Jose Manuel García Pinilla

Facility Name

Hospital Clinico Universitario de Valencia

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Julio Núñez Villota

First Name & Middle Initial & Last Name & Degree

Julio Núñez Villota

Facility Name

Hospital General Universitario de Valencia

City

Valencia

ZIP/Postal Code

46014

Country

Spain

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

José Pérez Silvestre

First Name & Middle Initial & Last Name & Degree

José Pérez Silvestre

Facility Name

Hospital Clínico Universitario Lozano de Blesa

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jorge Rubio Gracia

First Name & Middle Initial & Last Name & Degree

Jorge Rubio Gracia

12. IPD Sharing Statement

Plan to Share IPD

Yes

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Hypertonic Saline Therapy in Ambulatory Heart Failure Unit.

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