Back to resultsA Feasibility Non-inferiority Clinical Trial for Dosing of Diuretics in CHF Patients
Primary Purpose
Congestive Heart Failure
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Random dosage and time of furosemide
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure
Eligibility Criteria
Inclusion Criteria:
Ages Eligible for Study: 18 Years to 80 Years (Adult) Sexes Eligible for Study: All
- Patients with NYHA II-III HFrEF, mid-range HF and HFpEF according to ESC definitions.
- Patients taking at least 80 mg of furosemide daily in the 60 days previous to enrollment.
- Females of childbearing potential must be non-pregnant (as determined by a serum pregnancy test at screening and again, prior to each dosing session) and agree to use adequate contraceptive means throughout the study.
- No history of drug or alcohol abuse.
- Patients must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- Patients must satisfy a medical examiner about their fitness to participate in the study.
- Patients must provide written informed consent to participate in the study.
Exclusion Criteria:
- Patients with evidence of other serious infectious, malignant, autoimmune, kidney, hepatic, or other non-cardiac systemic disease.
- A major change in chronic therapies within 4 weeks.
- Over-the-counter drugs, including herbal medications, and prescription drugs (other than those listed above) are not allowed for 4 weeks prior to and throughout the duration of the study
- Participation in another clinical trial within 30 days prior to intervention.
- Patients with an inability to communicate well with the Principal investigator (PI) and staff (i.e., language problem, poor mental development or impaired cerebral function).
- Patients who will be unavailable for the duration of the trial, are likely to be noncompliant with the protocol, or who are felt to be unsuitable by the PI for any other reason.
Sites / Locations
- Hadassah Medical OrganizationRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Random dose
Arm Description
Random dosage and timing of furosemide
Outcomes
Primary Outcome Measures
Safety outcome
Patients will be monitored for safety that will be evaluated with creatinine level (normal values 62-115micromol/L higher values represent worsen kidney function), decompensation as determined by number of ER visits requiring intravenous diuretics and hospitalizations and higher diuretic dosage as a presentation of worsen heart failure
Efficacy outcome
KCCQ (possible range of 0-100 better score represents better functional status), NT-proBNP levels (normal values 0-125 pg/ml), 6 minute walk test in which higher walking distance represents better outcome
Secondary Outcome Measures
Full Information
NCT ID
NCT05379257
First Posted
December 6, 2020
Last Updated
May 17, 2022
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT05379257
Brief Title
A Feasibility Non-inferiority Clinical Trial for Dosing of Diuretics in CHF Patients
Official Title
A Feasibility Non-inferiority Clinical Trial for Dosing of Diuretics in CHF Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Patients with heart failure are frequently hospitalized, have a reduced quality of life and face a higher risk of death. Much of the morbidity and reduced quality of life associated with CHF is related to symptoms of volume overload. Loop diuretics are a mainstay in the management of volume overload and edema in CHF.
Diuretic resistance is defined as the clinical state in which diuretic response is diminished or lost before the goal of treatment has been achieved. Diuretic resistance has an adverse effect on clinical outcomes and is associated with a poor prognosis.
This open-labeled study will evaluate the option to overcome this resistance in patients with partial of complete loss of the effect via random drug administration using an app. In the present study, the investigators will add the use of a treatment schedule prepared by the physician for each of the patients. This schedule includes a treatment regimen based on the drugs the patient is taking in a pre-determined random change within their approved therapeutic window to be administered by an app.
Patients will be followed for 10 weeks and will be compared with their pre-intervention condition. The effect and safety of altering the treatment regimen will be assessed by the need for intravenous diuretics, hospitalizations and emergency department admission and by Kansas City Cardiomyopathy Questionnaire (KCCQ), 6 minutes walk test, creatinine level and pro BNP levels.
Detailed Description
The objective of this study is to show non-inferiority in dosing diuretics using an app compared with standard of care, and to determine the safety and efficacy of using a diuretic dosing regimen provided by an app when administered to CHF patients with diuretic resistance.
Following 4 weeks of stabilization where all patients participating in the trial will receive their diuretics dosing in the conventional way by their health care provider, ten patients will start a 10-week intervention where they will be taking diuretics according to an irregular schedule which is within a range that was determined by their physician and within the therapeutic window. The app will change the dose and time in the day of taking the diuretics within the pre-determined ranges.The physician is required to provide each patient with a dosing range for his diuretics, while keeping the therapy within the approved therapeutic window. Irregularity is made daily by the app. Each patient will serve as his or her own control by comparing the effect of using the app to the effects of diuretics administered over the four weeks' period when he was using the diuretics without an app.
Patients will be monitored for safety that will be evaluated with creatinine level (normal values 62-115micromol/L higher values represent worsen kidney function), decompensation as determined by number of ER visits requiring intravenous diuretics and hospitalizations, and heart failure status that will be evaluated by diuretics dosage. Efficacy will be evaluated with KCCQ score (possible range of 0-100 better score represents better functional status), NT-proBNP levels (normal values 0-125 pg/ml) and 6 minutes walking test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Random dose
Arm Type
Experimental
Arm Description
Random dosage and timing of furosemide
Intervention Type
Combination Product
Intervention Name(s)
Random dosage and time of furosemide
Intervention Description
Random dosage and time of furosemide, using a designated app
Primary Outcome Measure Information:
Title
Safety outcome
Description
Patients will be monitored for safety that will be evaluated with creatinine level (normal values 62-115micromol/L higher values represent worsen kidney function), decompensation as determined by number of ER visits requiring intravenous diuretics and hospitalizations and higher diuretic dosage as a presentation of worsen heart failure
Time Frame
10 weeks
Title
Efficacy outcome
Description
KCCQ (possible range of 0-100 better score represents better functional status), NT-proBNP levels (normal values 0-125 pg/ml), 6 minute walk test in which higher walking distance represents better outcome
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages Eligible for Study: 18 Years to 80 Years (Adult) Sexes Eligible for Study: All
Patients with NYHA II-III HFrEF, mid-range HF and HFpEF according to ESC definitions.
Patients taking at least 80 mg of furosemide daily in the 60 days previous to enrollment.
Females of childbearing potential must be non-pregnant (as determined by a serum pregnancy test at screening and again, prior to each dosing session) and agree to use adequate contraceptive means throughout the study.
No history of drug or alcohol abuse.
Patients must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
Patients must satisfy a medical examiner about their fitness to participate in the study.
Patients must provide written informed consent to participate in the study.
Exclusion Criteria:
Patients with evidence of other serious infectious, malignant, autoimmune, kidney, hepatic, or other non-cardiac systemic disease.
A major change in chronic therapies within 4 weeks.
Over-the-counter drugs, including herbal medications, and prescription drugs (other than those listed above) are not allowed for 4 weeks prior to and throughout the duration of the study
Participation in another clinical trial within 30 days prior to intervention.
Patients with an inability to communicate well with the Principal investigator (PI) and staff (i.e., language problem, poor mental development or impaired cerebral function).
Patients who will be unavailable for the duration of the trial, are likely to be noncompliant with the protocol, or who are felt to be unsuitable by the PI for any other reason.
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yotam Kolben
Phone
972507866767
Email
yotamkol@hadassah.org.il
12. IPD Sharing Statement
Plan to Share IPD
No
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A Feasibility Non-inferiority Clinical Trial for Dosing of Diuretics in CHF Patients
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