heart disfunction Heart failure
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Before any study-specific procedure, including assessments for screening, the appropriate written informed consent must be obtained Man or woman 18 to 80 years of age Undergoing a planned, elective aortic valve replacement for the first time for aortic stenosis. Hemoglobin (Hb) concentration * 7.4 mmol/l and * 9.9 mmol/l within 7 days prior to surgery and no major acute blood loss since this Hb determination.
Exclusion criteria
Exclusion criteria: An unstable medical condition, defined as having been hospitalized for a non-cardiac condition within 4 weeks of screening, major surgery within 24 weeks of screening, or otherwise unstable in the judgment of the investigator (e.g., at risk of complications or adverse events unrelated to study participation). Clinical history of chronic kidney disease (CKD) (at any point prior to registration) defined as serum creatinine > 105 µmol/l for all females, > 130 µmol/l for black males, and > 115 µmol/l for non-black males. Clinically significant abnormality in chemistry, hematology, or urinalysis parameters performed within the screening period. Use of any erythropoietic protein (e.g., rHuEPO; Procrit®, Eprex®, Neorecormon®, Epogen®, Aranesp®) within 12 weeks of enrolment. Positive pregnancy test or known to be pregnant at the time of screening. Recent (within 3 months) history of alcohol or illicit drug abuse disorder, based on self-report. Participation in any investigational device or drug trial(s) or receiving other investigational agent(s) within 30 days. Known positive for HIV antibodies, hepatitis B surface antigen, or hepatitis C antibodies. Any condition (e.g., unsuitable anatomy of the atrium; psychiatric illness; etc.) or situation that, in the investigator*s opinion, could put the subject at significant risk, confound the study results, or interfere significantly with the subject*s participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is myocardial HIF signaling between patients with preserved versus compromised left ventricular systolic function. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint is the beta common receptor between patients with preserved versus compromised left ventricular systolic function. | — |
Countries
Netherlands
Outcome results
None listed