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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT00610051
Eligibility Criteria:
1. Patients older than 18 years of age, of any gender/sex and race/ethnicity
2. Patients with a diagnosis of advanced HFrEF as evidenced by (all must apply):
1. most recent LVEF( by conventional imaging method\<30% which was mwasured within 3 months prior randomization.
2. Nt-proBNP \>1500 ng/L or BNP \>300 ng/L at prior randomization
3. New York Heart Association (NYHA) functional class IIIb or IV, i.e., chronic dyspnoea or fatigue at rest or with minimal exertion for at least one month prior to consent.
4. Renal dysfunction reflected by a glomerular filtration rate (GFR) \<60 mL/min approximated by the Modification of Diet in Renal Disease formula.
5. A total symptom score of KCCQ of \<70measure within 24 hours of randomization
6. Patients on all appropriate recommended HF therapy.
3. Patient should not be receiving continuous or planned intermittent intravenous infusions with a positive inotropic or vasodilator drug in a non-hospitalized setting
4. Patients should not be considered as candidates for heart transplantation or LVAD for at least 6 months from randomization according to the opinion of the treating physician.
5. Women of childbearing potential (i.e., who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must commit either to abstain continuously from heterosexual sexual contact or to use at least one "highly effective" method of birth control (e.g., intrauterine device \[IUD\], hormonal contraception, tubal ligation, or partner's vasectomy) or two "effective" methods (e.g., latex condom, diaphragm, or cervical cap), beginning 4 weeks prior to screening and throughout study participation.
Note: As alprostadil is not genotoxic and female sexual partners of male study participants are not likely to have substantial exposure via semen, there are no contraception requirements for men.
6. Patients must be willing and able to give written informed consent, including local data privacy consents, as required
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00610051
Study Brief:
Protocol Section:
NCT00610051