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

University Hospital Essen

Status: Completed

Conditions: Patients With Advanced Cancer Receiving Specialized Palliative Care

Treatments: Drug: Heart failure medication; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05636774

22-10545-AF

Details and patient eligibility

About

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.

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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97 participants in 2 patient groups, including a placebo group

Heart failure medication arm

Experimental group

Description:

Combination of Sacubitril/valsartan, Ivabradine, Ferric carboxymaltose and/or Empagliflozin

Treatment:

Drug: Heart failure medication

Placebo arm

Placebo Comparator group

Description:

Placebo tables / infusion

Treatment:

Drug: Placebo