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

• Status: Not yet recruiting
• Trial end date: 2024-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Essen

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