ClinicalTrials.Veeva

Menu

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

L

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

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

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems