Empower the Heart of Patients With Terminal Cancer Using Cardiac Medicines Trial

The pathophysiological implications of various cancer diseases and anti-cancer therapies is the occurrence of a cardiac disease-like phenotype with cardiac dysfunction, cardiac wasting, and cardiac homeostasis changes (incl. fibrosis and apoptosis) in end-stage cancer patients, causing heart failure like syndrome with development of congestion, dyspnoea and severely reduced physical functioning. The present trial aims to evaluate, if a heart failure medication improves the self-care ability and self-reported health care status of patients with pre-terminal cancer in palliative care.

Inclusion criteria:Basic Criteria:Patients with solid cancer in Union internationale contre le cancer (UICC) stage 4 (in palliative care)3-6 months expected survival (minimum 4 weeks) as assessed according to local standardsPatients under optimised analgetic therapyGroup 1 Criteria:Heart rate >70 bpmNT-proBNP >600 pg/mlElevated high-sensitive troponin (>99th percentile of respective test)LVEF <55%Heart failure with preserved ejection fraction (HFpEF) likelihood medium or largeEvidence of left ventricular (LV) mass reduction >15% since start of cancerIron deficiency (ID) with transferrin saturation (TSAT) <20%Group 2 Criteria:4 m walking time (>=6.0 secs for 4m - test will be performed twice and the average time is calculated) or not able to walk 4m at all.Not being able to wash oneself in at least 3 of the last 7 daysPresence of shortness of breath (SoB) (NYHA IV)Requirement for inclusion:At least two fulfilled criteria of Group 1 PLUS at least one fulfilled criterion of Group 2Exclusion criteria:Previous participation in this trial. Participation is defined as randomisedOngoing haemodialysisPatients currently on intravenous ironAcute sepsis with at least 2 points at the quick sequential organ failure assessment (qSOFA) score. The use of i.v.-antibiotics is permitted in patients with a lower qSOFA score.Ongoing acute exacerbation of chronic obstructive pulmonary disease (COPD) Acute ST elevation myocardial infarction (STEMI) or severe pulmonary embolism (PE) or severe deep vein thrombosis (DVT) (currently or in last 4 weeks)Current uncontrolled cerebral metastasisImpaired neurological status, precluding the ability to walkUnable or unwilling to give written informed consentParticipation in other interventional trials using investigational products in randomised settings