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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05636774

Studienbeginn:
Dezember 2022

Letztes Update:
29.11.2023

Wirkstoff:
Heart failure medication, Placebo

Indikation (Clinical Trials):
Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 4

Sponsor:
University Hospital, Essen

Collaborator:
-

Studienleiter

Tienush Rassaf, MD
Principal Investigator
University Hospital, Essen

Kontakt

Tienush Rassaf, MD
Kontakt:
Phone: +49201723
Phone (ext.): 4801
E-Mail: tienush.rassaf@uk-essen.de» Kontaktdaten anzeigen

Amir A Mahabadi, MD
Kontakt:
Phone: +49201723
Phone (ext.): 84822
E-Mail: amir-abbas.mahabadi@uk-essen.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital Essen
45147 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Tienush Rassaf, MD
Phone: +49201723
Phone (ext.): 4801
E-Mail: tienush.rassaf@uk-essen.de

Amir A Mahabadi, MD
Phone: +49201723
Phone (ext.): 84822
E-Mail: amir-abbas.mahabadi@uk-essen.de» Ansprechpartner anzeigen

Studien-Informationen

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 pre-terminal cancer in palliative care.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Days alive and able to wash themselves (Time Frame - since baseline during 30 days of follow-up):
patient performed act of washing by him/her-selves without interference of staff (regardless of whether as shower or bath, on a sink, or using a "sponge bath" in the bed)

Studien-Arme

Experimental: Heart failure medication arm
Combination of Sacubitril/valsartan, Ivabradine, Ferric carboxymaltose and/or Empagliflozin
Placebo Comparator: Placebo arm
Placebo tables / infusion

Geprüfte Regime

Heart failure medication:
Combination of Sacubitril/valsartan, Ivabradine, Ferric carboxymaltose and/or Empagliflozin.
Placebo:
Placebo tables / infusion

Quelle: ClinicalTrials.gov

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