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

NCT ID: NCT05636774

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-12
• Study Completion Date: 2025-03-01

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.

Conditions

Patients With Advanced Cancer Receiving Specialized Palliative Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Heart failure medication arm

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

Group Type: EXPERIMENTAL

Heart failure medication

Intervention Type: DRUG

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

Placebo arm

Placebo tables / infusion

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tables / infusion

Interventions

Heart failure medication

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

Intervention Type: DRUG

Placebo

Placebo tables / infusion

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

Universitätsklinikum Leipzig

OTHER

Sponsor Role: collaborator

University Hospital Heidelberg

OTHER

Sponsor Role: collaborator

University Hospital Homburg/Saar

UNKNOWN

Sponsor Role: collaborator

University Hospital, Essen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tienush Rassaf, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Essen

Locations

University Hospital Essen

Essen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

22-10545-AF

Identifier Type: -

Identifier Source: org_study_id