Back to resultsTranslational and Clinical Aspects of Metabolic, Anabolic and Endothelial Dysfunction in Heart Failure (MetAnEnd-HF)
Primary Purpose
Heart Failure With Reduced Ejection Fraction HFrEF
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Ghrelin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction HFrEF focused on measuring cardiac output
Eligibility Criteria
Inclusion Criteria:
- Current or past signs of clinical HF according to the Framingham criteria
- LVEF<40%
- NT-proBNP > 300 ng/L
Exclusion Criteria:
- Inability to or unwillingness to provide informed consent,
- Participation in research study that involves research drug administration or contraindication to any of the clinically indicated procedures.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ghrelin infusion
Placebo
Arm Description
Ghrelin infusion 30 pmol/kg/min, 0.50 ml/min during 120 minutes
Saline 0.50 ml/min during 120 minutes
Outcomes
Primary Outcome Measures
Change in cardiac output between treament groups
Assessed by non-invasive inert gas rebreathing technique (L/min)
Secondary Outcome Measures
Change in endothelial function between treament groups
Assessed non-invasive by flow mediated dilatory capability of the brachial artery (mm)
Change in cardiac function between treament groups
Assessed by echocardiography (left ventricular ejection fraction, strain, TAPSE)
GH biomarker
Circulating biomarkers (GH)
ghrelin biomarker
Circulating biomarkers ( ghrelin)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05277415
Brief Title
Translational and Clinical Aspects of Metabolic, Anabolic and Endothelial Dysfunction in Heart Failure
Acronym
MetAnEnd-HF
Official Title
Translational and Clinical Aspects of Metabolic, Anabolic and Endothelial Dysfunction in Herat Failure
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 17, 2013 (Actual)
Primary Completion Date
May 22, 2014 (Actual)
Study Completion Date
May 22, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lars Lund
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Reduced Ejection Fraction HFrEF
Keywords
cardiac output
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Double-blind, randomized, parallellel intervention study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ghrelin infusion
Arm Type
Active Comparator
Arm Description
Ghrelin infusion 30 pmol/kg/min, 0.50 ml/min during 120 minutes
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline 0.50 ml/min during 120 minutes
Intervention Type
Biological
Intervention Name(s)
Ghrelin
Intervention Description
Ghrelin infusion
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in cardiac output between treament groups
Description
Assessed by non-invasive inert gas rebreathing technique (L/min)
Time Frame
Procedure (At the end of ghrelin administration)
Secondary Outcome Measure Information:
Title
Change in endothelial function between treament groups
Description
Assessed non-invasive by flow mediated dilatory capability of the brachial artery (mm)
Time Frame
Procedure (At the end of ghrelin administration)
Title
Change in cardiac function between treament groups
Description
Assessed by echocardiography (left ventricular ejection fraction, strain, TAPSE)
Time Frame
Procedure (At the end of ghrelin administration)
Title
GH biomarker
Description
Circulating biomarkers (GH)
Time Frame
Procedure (At the end of ghrelin administration)
Title
ghrelin biomarker
Description
Circulating biomarkers ( ghrelin)
Time Frame
Procedure (At the end of ghrelin administration)
10. Eligibility
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Current or past signs of clinical HF according to the Framingham criteria
LVEF<40%
NT-proBNP > 300 ng/L
Exclusion Criteria:
Inability to or unwillingness to provide informed consent,
Participation in research study that involves research drug administration or contraindication to any of the clinically indicated procedures.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Translational and Clinical Aspects of Metabolic, Anabolic and Endothelial Dysfunction in Heart Failure
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