A Feasibility Non-inferiority Clinical Trial for Dosing of Diuretics in CHF Patients

NCT05379257 | Unknown

• 1 other identifier: RANDFURO- HMO-CTIL
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Congestive Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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

  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

  10 weeks

Study Arms (1)

Random dose

EXPERIMENTAL

Random dosage and timing of furosemide

Combination Product: Random dosage and time of furosemide

Interventions

Random dosage and time of furosemide COMBINATION_PRODUCT

Random dosage and time of furosemide, using a designated app

Random dose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: December 6, 2020
• First Posted: May 18, 2022
• Study Start: January 20, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)