Patients With Advanced Cancer Receiving Specialized Palliative Care
Conditions
Brief 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.
Interventions
Combination of Sacubitril/valsartan, Ivabradine, Ferric carboxymaltose and/or Empagliflozin.
DRUGPlacebo
Placebo tables / infusion
Sponsors
Charite University, Berlin, Germany
Universitätsklinikum Leipzig
University Hospital Heidelberg
University Hospital Homburg/Saar
University Hospital, Essen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Note: We involve blinded and unblinded study investigators.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 (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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | since baseline during 30 days of follow-up | The primary endpoint is analyzed using the win ratio approach, comparing patient pairs based on the hierarchy of the following 3 components: 1. The first component, days alive and able to wash themselves, was assessed over a 30 ± 2-day period, with counts ranging from 0 to 32 days. 2. The second component, ability to walk 4 meters, was assessed at Days 10, 20, and 30, with counts ranging from 0 to 3 visits. 3. The third component, self-reported PGA of subjective well-being, was assessed at the last common assessment visit where both patients were alive (Day 30, 20, or 10) using a 7-point Likert scale. |
Countries
Germany
Outcome results
None listed