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Hypertonic Saline Therapy in Ambulatory Heart Failure Unit.

NCT04533997 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2023-11-09

No results posted yet for this study

Summary

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.

Conditions

Interventions

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: 3.4%, Na+ 135-145: 2.6%

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

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Spanish Society of Cardiology

    collaborator OTHER

  • Puerta de Hierro University Hospital

    lead OTHER

Principal Investigators

  • Marta Cobo Marcos, MD · Hospital Universitario Puerta de Hierro. Madrid. Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2023-05-10
Completion
2023-09-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04533997 on ClinicalTrials.gov