I50.12 I50.13 I50.14
Conditions
Interventions
Group 1: Control Group: Best supportive cardiac care (BSCC, reactive) with visits every 3 months over 12 months according to guidelines (diet, medication, compliance control, organ monitoring (laborar
Sponsors
Uniklinik BonnMedizinische Klinik II
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint: - Health related quality-of-life-measurements assessed at 12 months and measured by the Functional Assessment of Chronic Illness Therapy– Palliative Care scale (FACIT–Pal) and the Kansas City Cardiomyopathy Questionnaire (KCCQ) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: - Depression and anxiety score (HADS-D) every 3 months - Symptom burden score (MIDOS) at baseline and end of study - Spiritual well-being (measured via the FACIT–Spiritual Well-Being scale (FACIT-Sp)) at baseline and end of study - Number of hospital readmissions, total number of hospital days due to HF (end of study) - Overall survival (end of study) - Medical resource and cost assessment (end of study) | — |
Countries
Germany
Contacts
Public ContactMarc Ulrich Becher
Uniklinik Bonn Medizinische Klinik II
Outcome results
None listed