Clinical trial NCT05636774: Empower the Heart of Patients With Terminal Cancer Using Cardiac Medicines Trial
Official title: Empower the Heart of Patients With Terminal Cancer Using Cardiac Medicines Trial - EMPATICC (INCOR1)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pre-terminal Cancer
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 pre-terminal cancer in palliative care.


Eligibility criteria: 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

Primary outcomes:
measure: Days alive and able to wash themselves
timeFrame: since baseline during 30 days of follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital Essen
state: NRW
Study officials:
affiliation: University Hospital, Essen
name: Tienush Rassaf, MD
role: PRINCIPAL_INVESTIGATOR
References: