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

Launched by UNIVERSITY HOSPITAL, ESSEN · Nov 23, 2022

Keywords

ClinConnect Summary

The "Empower the Heart of Patients With Terminal Cancer Using Cardiac Medicines Trial" is studying whether a medication typically used for heart failure can help improve the health and daily living abilities of patients with advanced cancer who are receiving palliative care. This trial specifically looks at patients who are nearing the end of their cancer journey and may be experiencing heart-related issues that affect their quality of life, such as trouble breathing and reduced physical strength.

To participate in this trial, patients must be diagnosed with stage 4 solid cancer and have a life expectancy of 3 to 6 months. They should also be receiving proper pain management. Eligible participants will have specific heart health indicators, like an elevated heart rate or heart function measurements that suggest heart strain. Those who join the study can expect to receive careful monitoring and support from the research team as they assess how the heart medication impacts their overall health and ability to care for themselves. It's important to note that certain conditions, like severe kidney problems or recent serious health events, may prevent someone from participating in the trial.

Gender

ALL

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

Trial Officials