A Feasibility Non-inferiority Clinical Trial for Dosing of Diuretics in CHF Patients - Trial NCT05379257

Timeline & Enrollment

Primary Outcome

Safety outcome,Efficacy outcome

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.

ICD-10 Classifications