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

• Sponsor: Jan Kochanowski University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05652322
• Collaborator: (none)
• Enrollment: 200
• Locations: 3
• Arms: 3
• Anticipated Duration (Months): 14.8
• Patients Per Site: 66.7
• Patients Per Site Per Month: 4.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Drug: Furosemide Pill 150% equivalent iv dose; Drug: Furosemide Pill 200% equivalent iv dose; Drug: Furosemide Injection	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Dec 7, 2022
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 prolonged intravenous loop diuretic treatment - furosemide	Drug: Furosemide Injection; change from intravenous to oral furosemide
Experimental: Group 2 Early (48 hrs) change to oral loop diuretic - furosemide - 150% eqivalent iv dose	Drug: Furosemide Pill 150% equivalent iv dose; change from intravenous to oral furosemide
Experimental: Group 3 Early (48 hrs) change to oral loop diuretic - furosemide - 200% eqivalent iv dose	Drug: Furosemide Pill 200% equivalent iv dose; change from intravenous to oral furosemide

Outcome Measures

Primary Outcome Measures

1. number of patients requiring hospitalization [12 weeks]

   any hospitalization due to cardiovascular reasons

2. Time to hospitalization measured in days [Up to 12 weeks]

   Time to any hospitalization due to cardiovascular reasons

Secondary Outcome Measures

1. Death [12 weeks]

   Cardiovascular death

2. New York Heart Association NYHA class [6 and12 weeks]

   NYHA class assessment

3. assessment of quality of life [12 weeks]

   QoL by Minnesota questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

1. 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

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

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

3. Age >= 18 years

4. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wojewodzki Szpital Zespolony Klinika Nefrologii	Kielce		Poland
2	Wojewódzki Szpital Zespolony OIOK	Kielce		Poland
3	Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika, Oddzial Kardiologii	Łódź		Poland

Sponsors and Collaborators

• Jan Kochanowski University

Investigators

• Principal Investigator: Janusz Sielski, MD, PhD, Jan Kochanowski Univeristy in Kielce

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Zbigniew Siudak, Professor, Jan Kochanowski University
• ClinicalTrials.gov Identifier: NCT05652322
• Other Study ID Numbers: 1/KCW/2022
• First Posted: Dec 15, 2022
• Last Update Posted: Dec 23, 2022
• Last Verified: Dec 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zbigniew Siudak, Professor, Jan Kochanowski University: diuretic; oral; intravenous
• Additional relevant MeSH terms: Heart Failure; Furosemide

Study Results

No Results Posted as of Dec 23, 2022