Clinical trial · Interventional
Empower the Heart of Patients With Terminal Cancer Using Cardiac Medicines Trial
Empower the Heart of Patients With Terminal Cancer Using Cardiac Medicines Trial - EMPATICC (INCOR1)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Patients With Advanced Cancer Receiving Specialized Palliative Care | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Heart failure medication | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Heart failure medication arm
- description
- Combination of Sacubitril/valsartan, Ivabradine, Ferric carboxymaltose and/or Empagliflozin
- interventionNames
- Drug: Heart failure medication
- type
- PLACEBO_COMPARATOR
- label
- Placebo arm
- description
- Placebo tables / infusion
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Win ratio with the following 3 hierarchical components: (1) days alive and able to wash oneself, (2) ability to walk 4m, (3) self-reported patient global assessment of subjective well-being, during the 30-day placebo-controlled phase
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available