I50.12 I50.13
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Age between 18 and 85 years (typical age cohort in systolic HI studies) • Diagnosis of chronic systolic dysfunction (LVEF <40%, diagnosed via echocardiography) • The underlying disease is a dilated cardiomyopathy, ischemic heart disease or hypertensive heart failure • NYHA Class II or III or Stage C of the ACC / AHA classification • Intrinsic sinus rhythm • subjectl understand the principle of the study and has the physical, psychological and cognitive requirements for learning AT and gives written consent.
Exclusion criteria
Exclusion criteria: • Diagnosed heart failure with preserved ejection fraction • Atrial fibrillation and chronotropic incompetence • Myocarditis in the past six months • Alcohol or drug abuse in the past six months • Currently severe symptomatic heart valve stenosis or regurgitation • Unstable angina pectoris • Chronic renal failure • Diagnosis of a mental disorder (F48.1, F44.x) • Gastrointestinal disorder (K27, K28 and K92), because activation of the solar plexus by AT promotes blood flow to the tissues • Implanted mechanical cardiac assist system • Treatment with anti-TNF therapy, for example for rheumatism or psoriasis • Other serious illness (e.g. advanced cancer) • Lack of German language skills. • The screening for AT (anamnesis sheet AT-ANAM) provides indications of contraindications and lack of motivation that lead to exclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in objectively recorded stress markers from T1 to T2 and to T3 willl be examined as primary outcomes. 1) Changes in blood pressure and autonomic nervous system: · Systolic and diastolic blood pressure, pulse · Plasma adrenaline / noradrenaline concentrations. The blood samples are taken i the supine position after a 10-minute habituation period in order to avoid a significant increase in the catecholamine concentration. · Alpha-amylase in saliva, determined as a morning and day profile on two consecutive days with a total of 14 measurement times. 2) Changes in the activation of the HPA axis: · Salivary cortisol, determined as a morning and day profile (cortisol awakening response with 4 samples in the morning: +1, +15, +30, +60 min, additionally one sample at 11 a.m., 3 p.m. and 8 p.m.). In order to obtain stable values, the measurement is repeated on the following day, so that a total of 14 measurement times result. MemsCaps are used to control when the samples were taken. 3) Changes in inflammatory markers: · Plasma concentrations of the proinflammatory cytokines TNF-a and interleukin-6 · Plasma concentrations of the anti-inflammatory cytokine IL-10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary outcomes will be changes in the subjective stress levels from T1 to T2 and to T3 by established standardized measurement instruments. · Stressors and stress levels (Trier inventory of chronic stress; TICS) · Symptoms and complaint burden (change-sensitive symptom list on relaxation experience, well-being, complaint and symptom burden; ASS-SYM) · State and trait depression and state and trait anxiety (State-Trait-Anxiety-Depression Inventory; STADI) · Self-reported coping (stress management questionnaire; SVF 120-S) In addition, changes in indicators of disease severity from T1 to T2 and to T3 will be recorded as exploratory outcomes: · Plasma concentration of the N-terminal pro brain natriuretic peptide (NT-proBNP) · 6-minutes walking distance | — |
Countries
Germany
Contacts
Universität Trier, Fachbereich I - Pflegewissenschaft, Abteilung für Diagnostik in der Gesundheitsversorgung & E-Health