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Trial Title:
Empower the Heart of Patients With Terminal Cancer Using Cardiac Medicines Trial
NCT ID:
NCT05636774
Condition:
Pre-terminal Cancer
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
Note: We involve blinded and unblinded study investigators.
Intervention:
Intervention type:
Drug
Intervention name:
Heart failure medication
Description:
Combination of Sacubitril/valsartan, Ivabradine, Ferric carboxymaltose and/or
Empagliflozin.
Arm group label:
Heart failure medication arm
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo tables / infusion
Arm group label:
Placebo arm
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 pre-terminal cancer in palliative care.
Criteria for eligibility:
Criteria:
Inclusion criteria:
Basic Criteria:
- Patients with solid cancer in Union internationale contre le cancer (UICC) stage 4
(in palliative care)
- 3-6 months expected survival (minimum 4 weeks) 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital Essen
Address:
City:
Essen
Zip:
45147
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Tienush Rassaf, MD
Phone:
+49201723
Phone ext:
4801
Email:
tienush.rassaf@uk-essen.de
Contact backup:
Last name:
Amir A Mahabadi, MD
Phone:
+49201723
Phone ext:
84822
Email:
amir-abbas.mahabadi@uk-essen.de
Start date:
December 12, 2022
Completion date:
October 31, 2024
Lead sponsor:
Agency:
University Hospital, Essen
Agency class:
Other
Source:
University Hospital, Essen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05636774
