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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05652322
• Other study ID #: 1/KCW/2022
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: December 7, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: December 2022
• Source: Jan Kochanowski University
• Contact: Zbigniew Siudak, MD, PhD
• Phone: +48883992288
• Email: zbigniew.siudak[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Furosemide Pill 150% equivalent iv dose
change from intravenous to oral furosemide
• Furosemide Pill 200% equivalent iv dose
change from intravenous to oral furosemide
• Furosemide Injection
change from intravenous to oral furosemide

Locations

Country	Name	City	State
Poland	Wojewodzki Szpital Zespolony Klinika Nefrologii	Kielce
Poland	Wojewódzki Szpital Zespolony OIOK	Kielce
Poland	Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika, Oddzial Kardiologii	Lódz

Sponsors (1)

Lead Sponsor	Collaborator
Jan Kochanowski University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients requiring hospitalization	any hospitalization due to cardiovascular reasons	12 weeks
Primary	Time to hospitalization measured in days	Time to any hospitalization due to cardiovascular reasons	Up to 12 weeks
Secondary	Death	Cardiovascular death	12 weeks
Secondary	New York Heart Association NYHA class	NYHA class assessment	6 and12 weeks
Secondary	assessment of quality of life	QoL by Minnesota questionnaire	12 weeks

External Links

•   Department of Cardiology, Regional State Hospital in Kielce, Poland
•   Jan Kochanowski University Kielce, Poland