Translational and Clinical Aspects of Metabolic, Anabolic and Endothelial Dysfunction in Heart Failure (MetAnEnd-HF)

Lars Lund

Status and phase: Completed; Phase 2; Phase 1

Conditions: Heart Failure With Reduced Ejection Fraction HFrEF

Treatments: Biological: Ghrelin; Biological: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05277415

2008/1:12

Details and patient eligibility

About

In patients with HF cardiac output, metabolism and endothelial function will be studied during and after treatment with ghrelin infusion

Full 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%.

Enrollment: 31 patients

Sex

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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31 participants in 2 patient groups, including a placebo group

Ghrelin infusion

Active Comparator group

Description:

Ghrelin infusion 30 pmol/kg/min, 0.50 ml/min during 120 minutes

Treatment:

Biological: Ghrelin

Placebo

Placebo Comparator group

Description:

Saline 0.50 ml/min during 120 minutes

Treatment:

Biological: Placebo