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

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
Furosemide Pill 150% equivalent iv dose
Furosemide Pill 200% equivalent iv dose
Furosemide Injection
Sponsored by
Jan Kochanowski University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring diuretic, oral, intravenous

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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) 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 Exacerbation of heart failure treated with at least 40 mg of furosemide IV. (or 20 mg torasemide equivalent) Left ventricular ejection fraction < 50% (assessed and documented in the last 12 months prior to study entry) Age >= 18 years 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

Sites / Locations

  • Wojewodzki Szpital Zespolony Klinika NefrologiiRecruiting
  • Wojewódzki Szpital Zespolony OIOKRecruiting
  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika, Oddzial Kardiologii

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

prolonged intravenous loop diuretic treatment - furosemide

Early (48 hrs) change to oral loop diuretic - furosemide - 150% eqivalent iv dose

Early (48 hrs) change to oral loop diuretic - furosemide - 200% eqivalent iv dose

Outcomes

Primary Outcome Measures

number of patients requiring hospitalization
any hospitalization due to cardiovascular reasons
Time to hospitalization measured in days
Time to any hospitalization due to cardiovascular reasons

Secondary Outcome Measures

Death
Cardiovascular death
New York Heart Association NYHA class
NYHA class assessment
assessment of quality of life
QoL by Minnesota questionnaire

Full Information

First Posted
December 7, 2022
Last Updated
December 22, 2022
Sponsor
Jan Kochanowski University
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1. Study Identification

Unique Protocol Identification Number
NCT05652322
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 7, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jan Kochanowski University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
diuretic, oral, intravenous

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
prolonged intravenous loop diuretic treatment - furosemide
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Early (48 hrs) change to oral loop diuretic - furosemide - 150% eqivalent iv dose
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Early (48 hrs) change to oral loop diuretic - furosemide - 200% eqivalent iv dose
Intervention Type
Drug
Intervention Name(s)
Furosemide Pill 150% equivalent iv dose
Intervention Description
change from intravenous to oral furosemide
Intervention Type
Drug
Intervention Name(s)
Furosemide Pill 200% equivalent iv dose
Intervention Description
change from intravenous to oral furosemide
Intervention Type
Drug
Intervention Name(s)
Furosemide Injection
Intervention Description
change from intravenous to oral furosemide
Primary Outcome Measure Information:
Title
number of patients requiring hospitalization
Description
any hospitalization due to cardiovascular reasons
Time Frame
12 weeks
Title
Time to hospitalization measured in days
Description
Time to any hospitalization due to cardiovascular reasons
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Death
Description
Cardiovascular death
Time Frame
12 weeks
Title
New York Heart Association NYHA class
Description
NYHA class assessment
Time Frame
6 and12 weeks
Title
assessment of quality of life
Description
QoL by Minnesota questionnaire
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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) 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 Exacerbation of heart failure treated with at least 40 mg of furosemide IV. (or 20 mg torasemide equivalent) Left ventricular ejection fraction < 50% (assessed and documented in the last 12 months prior to study entry) Age >= 18 years 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zbigniew Siudak, MD, PhD
Phone
+48883992288
Email
zbigniew.siudak@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janusz Sielski, MD, PhD
Organizational Affiliation
Jan Kochanowski Univeristy in Kielce
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wojewodzki Szpital Zespolony Klinika Nefrologii
City
Kielce
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pawel Wrobel, MD, PhD
Facility Name
Wojewódzki Szpital Zespolony OIOK
City
Kielce
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janusz Sielski, MD, PhD
First Name & Middle Initial & Last Name & Degree
Karol Kazirod-Wolski, MD, PhD
Facility Name
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika, Oddzial Kardiologii
City
Łódź
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grzegorz Piotrowski, MD, PhD

12. IPD Sharing Statement

Links:
URL
https://interna.ujk.edu.pl/
Description
Jan Kochanowski University Kielce, Poland

Learn more about this trial

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

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