The primary objective of this study is to asses whether HIF signaling pathways show less activity in patients with preserved ejection fraction compared to patients with systolic dysfunction. Secondary objectives are to assess the relation between…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is myocardial HIF signaling between patients with preserved
versus compromised left ventricular systolic function.
Secondary outcome
Secondary endpoint is the beta common receptor between patients with preserved
versus compromised left ventricular systolic function.
Background summary
Erythropoietin therapy in heart failure shows promising effects, but possesses
undesirable side effects as well, trough elevated haemoglobin levels. The
effects of erythropoietin are mediated largely under hypoxic conditions.
Earlier research showed the HIF pathway might be of significance in the
pathofysiology in heart failure patients. Therefore this pathway needs to be
further explored.
Study objective
The primary objective of this study is to asses whether HIF signaling pathways
show less activity in patients with preserved ejection fraction compared to
patients with systolic dysfunction. Secondary objectives are to assess the
relation between cardiac hypertrophy and HIF signaling as well as the relation
between HIF and EPO signaling in chronic heart failure. Another objective is to
assess the relation between heart failure patients with preserved and ejection
fraction and systolic dysfunction and beta common subunit receptor.
Study design
Observational study
Study burden and risks
This study poses a limiting additional risk for the participating patients. The
collection of myocardial tissue trough biopsy is performed regularly. It is
invasive and provides the risk of perforation and bleeding.
Hanzeplein 1
Postbus 30.001, 9700 VB Groningen
NL
Hanzeplein 1
Postbus 30.001, 9700 VB Groningen
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31586.042.10 |