Characterization of soluble neprilysin as a biomarker in cancer patients before, during and after chemotherapy under oncological therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00017424

Enrollment

150

Registered

2019-07-29

Start date

2019-05-28

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I50

Interventions

Group 1: In a group of patients treated with potentially cardio-toxic chemotherapy, biomarker levels are determined and the clinical course is monitored.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: At-risk patients prior to the initiation of chemotherapy for the treatment of hematological malignancies (acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), Hodgkin's lymphoma (HL), non-Hodgkin's lymphoma (NHL)) and the treatment of breast cancer Cardiotoxicity risk score (CRS, see Appendix 1 to the study protocol) of =5 points before initiation of treatment.

Exclusion criteria

Exclusion criteria: 1. Patient is treated with neprilysin-inhibitors (Entresto) 2. Patient with known heart failure 3. Patient is pregnant or lactating 4. Patient is dependent on or employed by study personnel 5. Patient is held in an institution by legal or official order 6. Patient is incapable of giving consent

Design outcomes

Primary

Measure	Time frame
Serum concentration of soluble neprilysin as a biomarker in cancer patients before, during and after chemotherapy.	—

Secondary

Measure	Time frame
To investigate the prognostic relevance, determinants of biomarker levels and trajectories over time in cancer patients with a high risk of 1) LV dysfunction and 2) heart failure under potentially cardiotoxic chemotherapy as well as to observe the clinical course of these patients. LV dysfunction is defined as the relative percentage reduction in Global Longitudinal Strain (GLS) of >15% relative to baseline before chemotherapy, allowing the patient to serve as his or her own control. The abnormal GLS value should be confirmed by a repeat echocardiography. The repeat echocardiography should be performed 2 to 3 weeks after the initial abnormal echocardiography results occurred (J Am Soc Echocardiogr 2014;27:911-39). Heart failure is defined as a syndrome characterised by symptoms ± clinical signs such as dyspnea, fatigue (decline in performance) and /or fluid retention due to cardiac dysfunction, elevated natriuretic peptides (NT- proBNP > 125 pg/ml) and structural and/or functional disorders of the left ventricle validated by echocardiography (Eur Heart J. 2016 Jul 14;37(27):2129-2200.)	—

Measure

Time frame

To investigate the prognostic relevance, determinants of biomarker levels and trajectories over time in cancer patients with a high risk of 1) LV dysfunction and 2) heart failure under potentially cardiotoxic chemotherapy as well as to observe the clinical course of these patients. LV dysfunction is defined as the relative percentage reduction in Global Longitudinal Strain (GLS) of >15% relative to baseline before chemotherapy, allowing the patient to serve as his or her own control. The abnormal GLS value should be confirmed by a repeat echocardiography. The repeat echocardiography should be performed 2 to 3 weeks after the initial abnormal echocardiography results occurred (J Am Soc Echocardiogr 2014;27:911-39). Heart failure is defined as a syndrome characterised by symptoms ± clinical signs such as dyspnea, fatigue (decline in performance) and /or fluid retention due to cardiac dysfunction, elevated natriuretic peptides (NT- proBNP > 125 pg/ml) and structural and/or functional disorders of the left ventricle validated by echocardiography (Eur Heart J. 2016 Jul 14;37(27):2129-2200.)

—

Countries

Germany

Contacts

Public ContactDavid Scheer

Universitätsmedizin Oldenburg Klinikum Oldenburg AöR Universitätsklinik für Innere Medizin – Kardiologie

scheer.david@klinikum-oldenburg.de+4944140370202

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026