Patients With Advanced Cancer Receiving Specialized Palliative CareEMPATICCNCT05636774
Empower the Heart of Patients With Terminal Cancer Using Cardiac Medicines Trial
A study testing Heart failure medication in people with Patients With Advanced Cancer Receiving Specialized Palliative Care, run by University Hospital, Essen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Advanced Cancer Receiving Specialized Palliative Care
- What is being tested?
- Heart failure medication
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteGermany
- Study dates
- 12 Dec 2022to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Empower the Heart of Patients With Terminal Cancer Using Cardiac Medicines Trial - EMPATICC (INCOR1)
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.
- Being tested
- Heart failure medication, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart failure medicationDrug
Combination of Sacubitril/valsartan, Ivabradine, Ferric carboxymaltose and/or Empagliflozin.
PlaceboDrug
Placebo tables / infusion
| Study group | Role | What they receive |
|---|---|---|
| Heart failure medication arm | Experimental | Combination of Sacubitril/valsartan, Ivabradine, Ferric carboxymaltose and/or Empagliflozin Receives: Drug: Heart failure medication |
| Placebo arm | Placebo comparator | Placebo tables / infusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
- The second component, "ability to walk 4 meters," was assessed at Days 10, 20, and 30, with counts ranging from 0 to 3 visits.
- 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.
Measured: since baseline during 30 days of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start12 Dec 2022
- Primary completion31 Jan 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Advanced Cancer Receiving Specialized Palliative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Universitätsklinikum Leipzig, University Hospital Heidelberg, University Hospital Homburg/Saar
- Responsible party
- Sponsor
- Investigators
- Tienush Rassaf, MD, Principal investigator, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636774
- Sponsor's protocol ID
- 22-10545-AF
- Acronym
- EMPATICC
- Status last verified
- Aug 2025
- First submitted
- 23 Nov 2022
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empower the Heart of Patients With Terminal Cancer Using Cardiac Medicines Trial - EMPATICC (INCOR1)
- ClinicalTrials.gov ID
- NCT05636774
- Acronym / sponsor ID
- EMPATICC / 22-10545-AF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Universitätsklinikum Leipzig, University Hospital Heidelberg, University Hospital Homburg/Saar
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart failure medication arm | Experimental | Drug: Heart failure medicationCombination of Sacubitril/valsartan, Ivabradine, Ferric carboxymaltose and/or Empagliflozin |
| Placebo arm | Placebo comparator | Drug: PlaceboPlacebo tables / infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
- Heart rate >70 bpm
- NT-proBNP >600 pg/ml
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart failure medicationCombination of Sacubitril/valsartan, Ivabradine, Ferric carboxymaltose and/or Empagliflozin. | Drug | Heart failure medication arm |
| PlaceboPlacebo tables / infusion | Drug | Placebo arm |
Primary outcome
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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tienush Rassaf, MD principal investigator
University Hospital, Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart failure medication in people with Patients With Advanced Cancer Receiving Specialized Palliative Care, run by University Hospital, Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: since baseline during 30 days of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.