Completed

NCT Number: NCT05636774

Empower the Heart of Patients With Terminal Cancer Using Cardiac Medicines Trial

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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Key information

Conditions

Patients With Advanced Cancer Receiving Specialized Palliative Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heart failure medication

Drug

Combination of Sacubitril/valsartan, Ivabradine, Ferric carboxymaltose and/or Empagliflozin.

Placebo

Drug

Placebo tables / infusion

Primary outcomes

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:
- 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Collaborators

Charite University, Berlin, Germany
University Hospital Heidelberg
University Hospital Homburg/Saar
Universitätsklinikum Leipzig

Registry information

Official study title

Empower the Heart of Patients With Terminal Cancer Using Cardiac Medicines Trial - EMPATICC (INCOR1)

Acronym: EMPATICC

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2025
First posted: Dec 5, 2022
Registry last updated: Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.