Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT05379257
Eligibility Criteria:
Inclusion Criteria:
Ages Eligible for Study: 18 Years to 80 Years (Adult) Sexes Eligible for Study: All
1. Patients with NYHA II-III HFrEF, mid-range HF and HFpEF according to ESC definitions.
2. Patients taking at least 80 mg of furosemide daily in the 60 days previous to enrollment.
3. 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.
4. No history of drug or alcohol abuse.
5. Patients must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
6. Patients must satisfy a medical examiner about their fitness to participate in the study.
7. Patients must provide written informed consent to participate in the study.
Exclusion Criteria:
1. Patients with evidence of other serious infectious, malignant, autoimmune, kidney, hepatic, or other non-cardiac systemic disease.
2. A major change in chronic therapies within 4 weeks.
3. 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
4. Participation in another clinical trial within 30 days prior to intervention.
5. 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).
6. 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05379257
Study Brief:
Protocol Section:
NCT05379257