Congestive Heart FailureNCT05379257
A Feasibility Non-inferiority Clinical Trial for Dosing of Diuretics in CHF Patients
A study testing Random dosage and time of furosemide in people with Congestive Heart Failure, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Random dosage and time of furosemide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Jan 2020to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem
Yotam Kolben, 972507866767, yotamkol@hadassah.org.il
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Congestive Heart Failure
- Being tested
- Random dosage and time of furosemide
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Random dosage and time of furosemideCombination product
Random dosage and time of furosemide, using a designated app
| Study group | Role | What they receive |
|---|---|---|
| Random dose | Experimental | Random dosage and timing of furosemide Receives: Combination Product: Random dosage and time of furosemide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 weeks
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
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start20 Jan 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dean Nahman, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379257
- Sponsor's protocol ID
- RANDFURO- HMO-CTIL
- Status last verified
- May 2022
- First submitted
- 6 Dec 2020
- Last updated
- 18 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Non-inferiority Clinical Trial for Dosing of Diuretics in CHF Patients
- ClinicalTrials.gov ID
- NCT05379257
- Acronym / sponsor ID
- RANDFURO- HMO-CTIL
- Conditions
- Congestive Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Random dose | Experimental | Combination Product: Random dosage and time of furosemideRandom dosage and timing of furosemide |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Random dosage and time of furosemideRandom dosage and time of furosemide, using a designated app | Combination product | Random dose |
Primary outcome
Safety outcome
Time frame: 10 weeks
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
Time frame: 10 weeks
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Random dosage and time of furosemide in people with Congestive Heart Failure, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety outcome (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.