Early Palliative Care for patients with symptomatic Heart Failure

Not Applicable

• Conditions: I50.12; I50.13; I50.14

• Registration Number: DRKS00013922
• Lead Sponsor: niklinik BonnMedizinische Klinik II

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-16
• Study Completion: 2022-11-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

Age =18 years
- NYHA class II-IV symptoms (suspected cardiac dyspnea)
- Systolic HF with a LVEF =35% or HF with preserved ejection fraction (NYHA class II-IV, elevated natriuretic peptides (NP), left ventricular hypertrophy (LVH) or left atrial enlargement (LAE) or diastolic dysfunction
- BNP =100 pg/mL or NT proBNP =400 pg/mL
- Subjects with the ability to follow study instructions and likely to attend and complete all required visits
- Written informed consent

Exclusion Criteria

- Inability to read, understand and respond to questions in German
- Previous consultations of palliative care services
- Patients in intensive care unit, on a ventilator, pre- or post-heart transplant
- Non-cardiac terminal illness
- Women who are pregnant or planning to become pregnant, nursing women
- Simultaneously participation in another study or participation in any study involving administration of an investigational medicinal product within 30
days prior to study beginning
- Subjects with a physical or psychiatric condition which at the investigator’s discretion may put the subject at risk, may confound the trial results, or
may interfere with the subject’s participation in this study
- Known or persistent abuse of medication, drugs or alcohol

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Endpoint:<br>- Health related quality-of-life-measurements assessed at 12 months and measured by the Functional Assessment of Chronic Illness Therapy–<br>Palliative Care scale (FACIT–Pal) and the Kansas City Cardiomyopathy Questionnaire (KCCQ)

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoints:<br>- Depression and anxiety score (HADS-D) every 3 months<br>- Symptom burden score (MIDOS) at baseline and end of study<br>- Spiritual well-being (measured via the FACIT–Spiritual Well-Being scale (FACIT-Sp)) at baseline and end of study<br>- Number of hospital readmissions, total number of hospital days due to HF (end of study)<br>- Overall survival (end of study)<br>- Medical resource and cost assessment (end of study)