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

  • STATUS
    Recruiting
  • participants needed
    200
  • sponsor
    Jan Kochanowski University
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Updated on 16 December 2022
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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.

Details
Condition Heart Failure
Age 18years or above
Treatment Furosemide Injection, Furosemide Pill 150% equivalent iv dose, Furosemide Pill 200% equivalent iv dose
Clinical Study IdentifierNCT05652322
SponsorJan Kochanowski University
Last Modified on16 December 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patient hospitalized due to exacerbation of heart failure symptoms, where AHF is the main cause of hospitalization. To be included in the study, all criteria 1 to 6 must be met
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 the sacral part of the spine
Increased pressure in the jugular veins (>=8 cm H2O)
The concentration of natiuretic peptides must be assessed within 24 hours of
admission to the hospital and be
✔ NTpro-BNP >450 pg/mL for <55 years, 900 pg/mL for 55-75 years, and >1800
pg/mL for >75 years
Exacerbation of heart failure treated with at least 40 mg of furosemide IV. (or 20 mg torasemide equivalent)
Left ventricular ejection fraction < 50% (assessed and documented in the last 12 months prior to study entry)
Age >= 18 years
The study participant gave and signed an informed consent to participate in the study. No medical procedure related to the study was performed prior to giving informed consent

Exclusion Criteria

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