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| Name | Class |
|---|---|
| Charite University, Berlin, Germany | OTHER |
| Universitätsklinikum Leipzig | OTHER |
| University Hospital Heidelberg | OTHER |
| University Hospital Homburg/Saar |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart failure medication arm | Experimental | Combination of Sacubitril/valsartan, Ivabradine, Ferric carboxymaltose and/or Empagliflozin |
|
| Placebo arm | Placebo Comparator | Placebo tables / infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heart failure medication | Drug | Combination of Sacubitril/valsartan, Ivabradine, Ferric carboxymaltose and/or Empagliflozin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | The primary endpoint is analyzed using the win ratio approach, comparing patient pairs based on the hierarchy of the following 3 components:
| since baseline during 30 days of follow-up |
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Inclusion criteria:
Basic Criteria:
Group 1 Criteria:
Group 2 Criteria:
Requirement for inclusion:
At least two fulfilled criteria of Group 1 PLUS at least one fulfilled criterion of Group 2
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tienush Rassaf, MD | University Hospital, Essen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Essen | Essen | North Rhine-Westphalia | 45147 | Germany |
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| UNKNOWN |
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Note: We involve blinded and unblinded study investigators.
| Placebo | Drug | Placebo tables / infusion |
|