Clinical trial NCT05652322: Prolonged Intravenous Therapy Versus Early Initiation of an Oral Loop Diuretic in Decompensated Heart Failure
Official title: A Randomized Trial Comparing Prolonged Intravenous Therapy Versus Early Initiation of an Oral Loop Diuretic in Patients Hospitalized for Decompensated Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Heart Failure
Keywords: diuretic
oral
intravenous
Lead sponsor: Jan Kochanowski University
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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:

  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 the sacral part of the spine
     * Increased pressure in the jugular veins (\>=8 cm H2O)
  2. 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
  3. Exacerbation of heart failure treated with at least 40 mg of furosemide IV. (or 20 mg torasemide equivalent)
  4. Left ventricular ejection fraction \< 50% (assessed and documented in the last 12 months prior to study entry)
  5. Age \>= 18 years
  6. 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:

* 1. 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

Primary outcomes:
measure: number of patients requiring hospitalization
timeFrame: 12 weeks
measure: Time to hospitalization measured in days
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Death
timeFrame: 12 weeks
measure: New York Heart Association NYHA class
timeFrame: 6 and12 weeks
measure: assessment of quality of life
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Kielce
country: Poland
facility: Wojewodzki Szpital Zespolony Klinika Nefrologii
city: Kielce
country: Poland
facility: Wojewódzki Szpital Zespolony OIOK
city: Łódź
country: Poland
facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika, Oddzial Kardiologii
Study officials:
affiliation: Jan Kochanowski Univeristy in Kielce
name: Janusz Sielski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: