Heart Failure With Reduced Ejection Fraction HFrEF
Conditions
Keywords
cardiac output
Brief summary
In patients with HF cardiac output, metabolism and endothelial function will be studied during and after treatment with ghrelin infusion
Detailed description
In patients with HF cardiac output, metabolism and endothelial function will be studied during and after treatment with ghrelin infusion (single dose). The following parameters will be collected: routine clinical parameters, endothelial function, cardiac structure and function by echocardiography, non-invasively assessed cardiac output and hemodynamics, serologic and of cardiac and renal function, sympathetic and RAS activation, metabolism, anabolic hormone function, inflammation, fibrosis, oxidative stress and apoptosis. 15 patients each group in are adequate to detect a difference between groups and before vs after ghrelin administration in metabolism, anabolic function and endothelial function with a power of 90% and two-sided significance of 5%.
Interventions
BIOLOGICALGhrelin
Ghrelin infusion
BIOLOGICALPlacebo
Placebo
Sponsors
Lars Lund
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Double-blind, randomized, parallellel intervention study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Current or past signs of clinical HF according to the Framingham criteria 2. LVEF\<40% 3. NT-proBNP \> 300 ng/L
Exclusion criteria
1. Inability to or unwillingness to provide informed consent, 2. Participation in research study that involves research drug administration or contraindication to any of the clinically indicated procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cardiac output between treament groups | Procedure (At the end of ghrelin administration) | Assessed by non-invasive inert gas rebreathing technique (L/min) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in endothelial function between treament groups | Procedure (At the end of ghrelin administration) | Assessed non-invasive by flow mediated dilatory capability of the brachial artery (mm) |
| Change in cardiac function between treament groups | Procedure (At the end of ghrelin administration) | Assessed by echocardiography (left ventricular ejection fraction, strain, TAPSE) |
| GH biomarker | Procedure (At the end of ghrelin administration) | Circulating biomarkers (GH) |
| ghrelin biomarker | Procedure (At the end of ghrelin administration) | Circulating biomarkers ( ghrelin) |
Outcome results
None listed