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

NCT05636774 | Completed

• 1 other identifier: 22-10545-AF
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  since baseline during 30 days of follow-up

Study Arms (2)

Heart failure medication arm

EXPERIMENTAL

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

Drug: Heart failure medication

Placebo arm

PLACEBO COMPARATOR

Placebo tables / infusion

Drug: Placebo

Interventions

Heart failure medication DRUG

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

Heart failure medication arm

Placebo DRUG

Placebo tables / infusion

Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Basic Criteria:
• Patients with solid cancer in Union internationale contre le cancer (UICC) stage 4 (in palliative care)
• 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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Essen: lead
• Charite University, Berlin, Germany: collaborator
• Universitätsklinikum Leipzig: collaborator
• University Hospital Heidelberg: collaborator
• University Hospital Homburg/Saar: collaborator

Study Sites (1)

University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Study Officials

• Tienush Rassaf, MD

  University Hospital, Essen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Note: We involve blinded and unblinded study investigators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 5, 2022
• Study Start: December 12, 2022
• Primary Completion: January 31, 2025
• Study Completion: March 1, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)