Prolonged Intravenous Therapy Versus Early Initiation of an Oral Loop Diuretic in Decompensated Heart Failure

Last updated: February 18, 2025
Sponsor: Jan Kochanowski University
Overall Status: Trial Not Available

Phase

2/3

Condition

Heart Failure

Congestive Heart Failure

Chest Pain

Treatment

Furosemide Pill 200% equivalent iv dose

Furosemide Injection

Furosemide Pill 150% equivalent iv dose

Clinical Study ID

NCT05652322
1/KCW/2022
  • Ages > 18
  • All Genders

Study Summary

The goal of this clinical study is to compare treatment regimens of loop diuretics in patients with decompensated heart failure. The main aim is to answer if early change from intravenous to oral loop diuretics is safe and effective.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient hospitalized due to exacerbation of heart failure symptoms, where AHF is themain cause of hospitalization. To be included in the study, all criteria 1 to 6 mustbe met:
  1. Fluid Retention Features:
  • Described congestion above the lung fields on chest X-ray
  • rales on chest auscultation
  • Peripheral edema, yielding to pressure occurring within the limbs or thesacral part of the spine
  • Increased pressure in the jugular veins (>=8 cm H2O)
  1. The concentration of natiuretic peptides must be assessed within 24 hours ofadmission to the hospital and be: ✔ NTpro-BNP >450 pg/mL for <55 years, 900 pg/mL for 55-75 years, and >1800pg/mL for >75 years

  2. Exacerbation of heart failure treated with at least 40 mg of furosemide IV. (or 20 mg torasemide equivalent)

  3. Left ventricular ejection fraction < 50% (assessed and documented in the last 12 months prior to study entry)

  4. Age >= 18 years

  5. The study participant gave and signed an informed consent to participate in thestudy. No medical procedure related to the study was performed prior to givinginformed consent.

Exclusion

Exclusion Criteria:

  1. Shortness of breath caused by respiratory infection, exacerbation of bronchialasthma, COPD 2. Body temperature > 38 C, signs of active infection requiringantibiotic therapy, sepsis, infective endocarditis 3. An episode of acutecoronary syndrome, stroke or TIA within 6 months before randomization 4. Severevalvular disease requiring or in the process of qualifying for repair 5.Patients requiring dialysis (in the past, during hospitalization or in theprocess of qualifying for dialysis) 6. History of alcohol abuse in the last 2years before randomization 7. Pregnancy or breastfeeding 8. Active cancer or inremission for less than 5 years

Study Design

Treatment Group(s): 3
Primary Treatment: Furosemide Pill 200% equivalent iv dose
Phase: 2/3
Study Start date:
December 07, 2022
Estimated Completion Date:
March 01, 2024

Connect with a study center

  • Wojewodzki Szpital Zespolony Klinika Nefrologii

    Kielce,
    Poland

    Site Not Available

  • Wojewódzki Szpital Zespolony OIOK

    Kielce,
    Poland

    Site Not Available

  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika, Oddzial Kardiologii

    Łódź,
    Poland

    Site Not Available

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