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

NCT05379257 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-05-18

No results posted yet for this study

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

Interventions

COMBINATION_PRODUCT

Random dosage and time of furosemide

Random dosage and time of furosemide, using a designated app

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-20
Primary Completion
2022-12-01
Completion
2022-12-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05379257 on ClinicalTrials.gov