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

Study Overview
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Brief Summary
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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.

Official Title
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Empower the Heart of Patients With Terminal Cancer Using Cardiac Medicines Trial - EMPATICC (INCOR1)

Conditions
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Pre-terminal Cancer

Intervention / Treatment
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* Drug: Heart failure medication
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 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 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 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 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 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 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 in randomised settings

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heart failure medication arm<br>Combination of Sacubitril/valsartan, Ivabradine, Ferric carboxymaltose and/or Empagliflozin | Drug: Heart failure medication<br>* Combination of Sacubitril/valsartan, Ivabradine, Ferric carboxymaltose and/or Empagliflozin.<br>|
| Placebo Comparator: Placebo arm<br>Placebo tables / infusion | Drug: Placebo<br>* Placebo tables / infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days alive and able to wash themselves | patient performed act of washing by him/her-selves without interference of staff (regardless of whether as shower or bath, on a sink, or using a sponge bath in the bed) | since baseline during 30 days of follow-up |