Improving heart health in patients with terminal cancer using heart medications

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

This study tests if heart medication can help improve the quality of life for patients with terminal cancer who have heart problems.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Essen (Academic / other)
• Locations: 1 site (Essen, NRW)
• Trial ID: NCT05636774 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effects of heart failure medication on patients with pre-terminal cancer who are experiencing cardiac dysfunction. It focuses on improving self-care abilities and self-reported health status in patients receiving palliative care. Participants will be assessed for specific cardiac conditions and will either receive the heart medication or a placebo. The study aims to determine if treating cardiac issues can enhance the quality of life for these patients.

Who should consider this trial

Good fit: Ideal candidates are patients with stage 4 solid cancer in palliative care, showing signs of cardiac dysfunction and a limited life expectancy.

Not a fit: Patients without significant cardiac dysfunction or those not in the specified cancer stage may not benefit from this study.

Why it matters

Potential benefit: If successful, this could significantly improve the quality of life and self-care abilities for patients with terminal cancer experiencing heart-related issues.

How similar studies have performed: While the approach of using heart medications in cancer patients is being explored, this specific trial's focus on pre-terminal cancer patients is relatively novel.

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

Where this trial is running

Essen, NRW

• University Hospital Essen — Essen, Nrw, Germany (Recruiting)

Study contacts

• Principal investigator: Tienush Rassaf, MD — University Hospital, Essen
• Study coordinator: Tienush Rassaf, MD

Conditions Pre-terminal Cancer