| Protocol ID | NCT05636774 |
| Registration Date | 2022-12-05 |
| Status | completed |
| Sponsor | University Hospital, Essen |
| Country | Germany |
| Industry | not industry |
| Blinding | blinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2022-12-12 |
| Last Patient Out | 2025-03-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT05636774
Empower the Heart of Patients With Terminal Cancer Using Cardiac Medicines Trial - EMPATICC (INCOR1)
| Field |
OPENAI
gpt-4o Thinking: o3 4868ms / 8729 tok |
CLAUDE
claude-sonnet-4-20250514 5056ms / 10169 tok |
GLM
glm-5.1 9553ms / 8881 tok |
Review |
|---|---|---|---|---|
| rct_type | parallel RCT | parallel RCT | parallel RCT | OK |
| cancer_status | Cancer | Cancer | Cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient |
outpatient
inpatient → inpatient → outpatient
shaky reasoning✓ Unanimous
Initial: inpatient
Requery: inpatient — The study involves patients with advanced cancer receiving specialized palliative care, which typically implies an inpatient setting like a hospice or hospital.
Thinking: outpatient — Intervention involves administering heart-failure medications to advanced cancer patients in specialized palliative care without any statement that they are admitted or reside in an inpatient unit.
|
outpatient |
outpatient
outpatient
shaky reasoning✓ Unanimous
Initial: outpatient
|
OK |
| setting_place |
other
hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: other — The trial involves patients with advanced cancer receiving specialized palliative care but does not specify hospitalization; it may involve settings outside a hospital, such as outpatient or community settings.
|
other |
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The trial enrolls patients receiving 'specialized palliative care' with functional assessments like walking and washing, but lacks explicit details on the delivery location, making 'other' the appropriate default for unspecified outpatient, community, or mixed palliative settings.
|
OK |
| feasibility | fully powered RCT | fully powered RCT | fully powered RCT | OK |
| intervention_pharmacologic | yes | yes | yes | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex | no | yes | no | – |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | no | no | no | OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | yes | yes | yes | OK |
| outcome_qol |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The study does not utilize any validated Quality of Life instruments such as EORTC QLQ-C30, FACT-G, or SF-36; it focuses on self-reported patient global assessment of subjective well-being, which does not qualify as a QoL instrument.
|
yes |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The primary outcome measures are functional assessments and a global subjective well-being rating, which do not utilize a validated Quality of Life instrument such as the EORTC QLQ-C30, FACT-G, EQ-5D, or SF-36.
|
– |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — All primary outcomes focus on symptom relief and quality of life improvements for patients.
|
yes |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The primary outcomes (days alive and able to wash oneself, ability to walk 4m, and self-reported patient global assessment of subjective well-being) measure physical functioning and quality of life.
|
– |
| pharmacologic_sub |
off label use
controlled substances → off label use → off label use
shaky reasoning✓ Unanimous
Initial: controlled substances
Requery: off label use — The trial involves the use of heart failure medication, including Sacubitril/valsartan, Ivabradine, Ferric carboxymaltose, and Empagliflozin, for treating cardiac dysfunction in terminal cancer patients, which is not an approved indication for these drugs.
Thinking: off label use — All study drugs are already FDA/EMA-approved but are being tested for improving functional status in terminal cancer patients, an indication outside their current approvals.
|
other |
off label use
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The trial uses a combination of FDA-approved heart failure medications (Sacubitril/valsartan, Ivabradine, Ferric carboxymaltose, and/or Empagliflozin) to treat cardiac dysfunction in terminal cancer patients, which does not fit into the more specific categories.
|
– |