Translational and Clinical Aspects of Metabolic, Anabolic and Endothelial Dysfunction in Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-17

Study Completion Date

2014-05-22

Brief Summary

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

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Detailed Description

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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%.

Conditions

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Heart Failure With Reduced Ejection Fraction HFrEF

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blind, randomized, parallellel intervention study

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ghrelin infusion

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

Group Type ACTIVE_COMPARATOR

Ghrelin

Intervention Type BIOLOGICAL

Ghrelin infusion

Placebo

Saline 0.50 ml/min during 120 minutes

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo

Interventions

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Ghrelin

Ghrelin infusion

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No