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

University Hospital, Essen97 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Patients With Advanced Cancer Receiving Specialized Palliative Care

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

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

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.

Time frame: since baseline during 30 days of follow-up