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

A Randomized Trial Comparing Prolonged Intravenous Therapy Versus Early Initiation of an Oral Loop Diuretic in Patients Hospitalized for Decompensated Chronic Heart Failure

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Drug: Furosemide Injection; Drug: Furosemide Pill 150% equivalent iv dose; Drug: Furosemide Pill 200% equivalent iv dose

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Zbigniew Siudak, MD, PhD; Phone Number: +48883992288; Email: zbigniew.siudak@gmail.com

Study Locations

• Poland
  • Kielce, Poland
    • Recruiting
    • Wojewodzki Szpital Zespolony Klinika Nefrologii
    • Contact: Pawel Wrobel, MD, PhD
  • Kielce, Poland
    • Recruiting
    • Wojewódzki Szpital Zespolony OIOK
    • Contact: Janusz Sielski, MD, PhD
    • Sub-Investigator: Karol Kazirod-Wolski, MD, PhD
  • Łódź, Poland
    • Not yet recruiting
    • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika, Oddzial Kardiologii
    • Contact: Grzegorz Piotrowski, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients requiring hospitalization	any hospitalization due to cardiovascular reasons	12 weeks
Time to hospitalization measured in days	Time to any hospitalization due to cardiovascular reasons	Up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Cardiovascular death	12 weeks
assessment of quality of life	QoL by Minnesota questionnaire	12 weeks
New York Heart Association NYHA class	NYHA class assessment	6 and12 weeks

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 15, 2022

Study Record Updates

• Last Update Posted (Actual): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: oral; intravenous; diuretic
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium Potassium Chloride Symporter Inhibitors; Furosemide
• Other Study ID Numbers: 1/KCW/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No