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

Launched by JAN KOCHANOWSKI UNIVERSITY · Dec 7, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to give a medication called loop diuretics to patients with heart failure who are experiencing worsening symptoms. Specifically, the trial is comparing prolonged intravenous (IV) therapy to switching to oral loop diuretics earlier in the treatment process. The main goal is to find out if this early switch is safe and effective for patients.

To participate in the trial, patients must be hospitalized due to worsening heart failure and meet several criteria, such as showing signs of fluid buildup in the body and having certain test results. Eligible participants must be at least 18 years old and able to give their consent to join the study. If you join, you will be closely monitored as part of the study to see how well the different treatment methods work for your heart failure. It's important to note that certain patients, like those with active infections or severe heart conditions, will not be eligible for this trial.

Gender

ALL

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

Trial Officials