Empower the Heart of Patients With Terminal Cancer Using Cardiac Medicines Trial (NCT05636774) | Clinical Trial Compass
CompletedNot Applicable
Empower the Heart of Patients With Terminal Cancer Using Cardiac Medicines Trial
Germany97 participantsStarted 2022-12-12
Plain-language 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 with advanced cancer receiving specialized palliative care.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: since baseline during 30 days of follow-up