Status:
UNKNOWN
A Feasibility Non-inferiority Clinical Trial for Dosing of Diuretics in CHF Patients
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
NA
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 relate...
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 prov...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05379257
Start Date
January 20 2020
End Date
December 1 2022
Last Update
May 18 2022
Active Locations (1)
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1
Hadassah Medical Organization
Jerusalem, Israel