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

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.

Study Overview

• Status: Completed
• Conditions: Patients With Advanced Cancer Receiving Specialized Palliative Care
• Intervention / Treatment: Drug: Heart failure medication; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Essen, NRW, Germany, 45147
      • University Hospital Essen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Heart failure medication arm; Combination of Sacubitril/valsartan, Ivabradine, Ferric carboxymaltose and/or Empagliflozin	Drug: Heart failure medication; Combination of Sacubitril/valsartan, Ivabradine, Ferric carboxymaltose and/or Empagliflozin.
Placebo Comparator: Placebo arm; Placebo tables / infusion	Drug: Placebo; Placebo tables / infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: 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.	since baseline during 30 days of follow-up

Collaborators and Investigators

• Sponsor: University Hospital, Essen
• Collaborators: Charite University, Berlin, Germany; University Hospital Heidelberg; Universitätsklinikum Leipzig; University Hospital Homburg/Saar
• Investigators: Principal Investigator: Tienush Rassaf, MD, University Hospital, Essen

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2022
• Primary Completion (Actual): January 31, 2025
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: November 23, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 15, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 22-10545-AF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No