Trials Sponsors Conditions Drugs Pricing

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 medicationDrug

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

Heart failure medication arm

PlaceboDrug

Placebo tables / infusion

Placebo arm

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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)

Sponsors & Collaborators

University Hospital Homburg/Saar
Type not reportedcollaborator
Universitätsklinikum Leipzig
Othercollaborator
University Hospital Heidelberg

Study Sites (1)

University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

Study Officials

Tienush Rassaf, MD
University Hospital, Essen
PRINCIPAL INVESTIGATOR

Enrollment

97 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Heart failure medication arm

Placebo arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Heart failure medication arm

Placebo arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations