I35.0 I34.0
Conditions
Interventions
Group 1: 1. Clinical examination: height, weight, BMI, blood pressure, heart frequency, abdominal girth measurement, skin-fold measurement
2. echocardiography
3. blood test (standard of care)
4. sp
Sponsors
Immanuel Klinikum Bernau Herzzentrum BrandenburgChefarzt der Kardiologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Heart failure NYHA III/IV; patients with a high Level of aortic valve stenosis and planned TAVI or patients with a high Level of mitral regurgitation and planned MitraClip, informed consent of the patients
Exclusion criteria
Exclusion criteria: error or lack of legal capacity, life expectancy less than one year, fear or panic in confined places
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of this study is to systematically and prospectively assess the metabolic and nutritional status of heart failure patients suffering from severe symptomatic aortic valve stenosis and severe symptomatic mitral valve regurgitation in correlation to the extent of heart failure symptoms. Heart failure patients will be characterized clinically, functionally, and metabolically before, and 6 month and 12 month after interventional valve therapy to quantify changes of these parameters due to interventional valve therapy. Our intention is to better understand the underlying pathophysiology of heart failure caused by severe aortic valve stenosis and severe mitral valve regurgitation, and their existing relationship to cardiac cachexia. To reach this aim we want to determine clinical, functional, metabolic parameters and biomarkers, especially focusing on the ability of patients to recover from heart failure symptomatology following treatment. Methods: clinical investigation (body mass index (BMI), waist circumference, skin fold measurement), echocardiography, specific laboratory measurements (NT-pro-BNP, insulin, ghrelin, adiponectin, leptin, peptides, TNF alpha, GLP-1, ANP, P3NP, cholecystokinin). Insulin resistance measured as HOMA-Index in the blood. These parameters are measured before intervention, and 6 month and 12 months after the intervention during the follow-up visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| A further study aim is to measure energy metabolism and substrate utilization in heart failure patients suffering from severe aortic valve stenosis and severe mitral valve regurgitation, and before and after interventional valve therapy, and calculate their changes. Measurement method: Bioelectronic impedance analysis (BIA) and energy metabolism measurement by means of calorimetry. These parameters are measured before and 6 months after therapy (subgroup). | — |
Countries
Germany
Contacts
Public ContactAnne-Katrin Hübner
Immanuel Klinikum Bernau Herzzentrum BrandenburgKardiologische Studienambulanz
Outcome results
None listed