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:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
NCT ID:
NCT06054516
Eligibility Criteria:
Inclusion Criteria:
* Chronic heart failure
* \>18 years of age
* Left ventricular Ejection Fraction (LVEF) of 10 - 60 %
* Adequate hematologic and organ function.
* Women who are not postmenopausal or surgically sterile must have a negative serum or urine pregnancy test performed at time of inclusion in the study.
* Safe and highly effective contraception must be used throughout the study meaning either hormonal anti-conception or an anti-fertility intrauterine device. If the partner is non fertile or the patient has no sexual activities, this is also accepted.
* Non-insulin dependent Diabetes mellitus is allowed
* Danish speaking
* Able and willing to comply after informed consent
* Ischemic heart disease and referral to viability testing at the Department of Clinical Physiology and Nuclear Medicine at Aarhus University Hospital.
Exclusion Criteria:
* Not able or willing to receive heart failure therapy
* Patients not willing to participate
* Uncontrolled serious medical condition, such as uncontrolled heart disease, uncontrolled diabetes, intestinal obstruction, uncontrolled hypertension, or recent cerebral ischemia
* Estimated Glomerular Filtration Rate (eGFR) \<30 mL/min
* Insulin dependent Diabetes Mellitus
* Intolerance to Pyruvate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT06054516
Study Brief:
Protocol Section:
NCT06054516