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

Phase

N/A

Condition

Neoplasms

Treatment

Placebo

Heart failure medication

Clinical Study ID

NCT05636774

22-10545-AF

Ages > 18
All Genders

Study Summary

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 with advanced cancer receiving specialized palliative care.

Eligibility Criteria

Inclusion

Inclusion criteria:

Basic Criteria:

Patients with solid cancer in Union internationale contre le cancer (UICC) stage 4 (in palliative care)
1-6 months expected survival as assessed according to local standards
Patients under optimised analgetic therapy

Group 1 Criteria:

Heart rate >70 bpm
NT-proBNP >600 pg/ml
Elevated high-sensitive troponin (>99th percentile of respective test)
LVEF <55%
Heart failure with preserved ejection fraction (HFpEF) likelihood medium or large
Evidence of left ventricular (LV) mass reduction >15% since start of cancer
Iron 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 averagetime is calculated) or not able to walk 4m at all.
Not being able to wash oneself in at least 3 of the last 7 days
Presence 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 2

Exclusion

Exclusion criteria:

Previous participation in this trial. Participation is defined as randomised
Ongoing haemodialysis
Patients currently on intravenous iron
Acute 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 lowerqSOFA score.
Ongoing acute exacerbation of chronic obstructive pulmonary disease (COPD) Acute STelevation myocardial infarction (STEMI) or severe pulmonary embolism (PE) or severedeep vein thrombosis (DVT) (currently or in last 4 weeks)
Current uncontrolled cerebral metastasis
Impaired neurological status, precluding the ability to walk
Unable or unwilling to give written informed consent
Participation in other interventional trials using investigational products inrandomised settings

Study Design