Pyruvic acid for Heart failure

Inclusion criteria

• {"criterion_text":"- Chronic heart failure (Heart failure with both reduced and preserved EF are allowed) > 18 years of age."}
• {"criterion_text":"- Left ventricular Ejection Fraction (LVEF) of 10 – 60 %"}
• {"criterion_text":"- Adequate hematologic and organ function, i.e. ANC at least 1.500/uL"}
• {"criterion_text":"- Platelet count >100/uL"}
• {"criterion_text":"- Se creatinine up to 1.5 x UNL or creatinine clearance at least 30 ml/min"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Non-insulin dependent Diabetes mellitus is allowed"}
• {"criterion_text":"- Danish speaking"}
• {"criterion_text":"- Able and willing to comply after informed consent"}
• {"criterion_text":"- For substudy 1A only: Ischemic heart disease and referral to viability testing at the Department of Clinical Physiology and Nuclear Medicine at Aarhus University Hospital, Skejby."}

Exclusion criteria

• {"criterion_text":"- Not able or willing to receive heart failure therapy"}
• {"criterion_text":"- Patients not willing to participate"}
• {"criterion_text":"- Uncontrolled serious medical condition, such as uncontrolled heart disease, uncontrolled diabetes, intestinal obstruction, uncontrolled hypertension, or recent cerebral ischemia"}
• {"criterion_text":"- Receiving more than 50% of taget dose of ACE-inhibitor and betablockers before inclusion in study 1 (this does not apply for substudy 1A)"}
• {"criterion_text":"- Estimated Glomerular Filtration Rate (eGFR) <30 mL/min"}
• {"criterion_text":"- Insulin dependent Diabetes Mellitus"}
• {"criterion_text":"- Intolerance to Pyruvate"}

Primary endpoints

• {"endpoint_text":"- Metabolic in vivo flux through the PDC in the myocardium in humans. Co-primary endpoints are: a) [13C]-bicarbonate/[1-13C]-pyruvate ratio, b) [1-13C]-lactate / [1-13C]-pyruvate ratio and [1-13C]-lactate / [1-13C]-bicarbonate ratio. The latter gives ratio indices of PDC-mediated pyruvate oxidation and lactate production via lactate dehydrogenase.","definition_or_measurement_approach":"Measured as ratios of 13C-labeled metabolites ([13C]-bicarbonate/[1-13C]-pyruvate; [1-13C]-lactate/[1-13C]-pyruvate; [1-13C]-lactate/[1-13C]-bicarbonate) using hyperpolarized [1-13C]-pyruvate imaging to quantify PDC-mediated pyruvate oxidation and lactate production."}

Denmark

Latest Decision Or Authorization Date

16-09-2024

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Region Midtjylland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"1","organisation_type":"Educational Institution"}