Heart Failure With Reduced Ejection Fraction HFrEFPhase 1/2MetAnEnd-HFNCT05277415
Translational and Clinical Aspects of Metabolic, Anabolic and Endothelial Dysfunction in Heart Failure
A Phase 1/2 study testing Ghrelin in people with Heart Failure With Reduced Ejection Fraction HFrEF, run by Lars Lund.
Trial summary
In patients with HF cardiac output, metabolism and endothelial function will be studied during and after treatment with ghrelin infusion Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction HFrEF
- What is being tested?
- Ghrelin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 17 Feb 2013to 22 May 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current or past signs of clinical HF according to the Framingham criteria
- LVEF<40%
- NT-proBNP > 300 ng/L
Who cannot join
- 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.
About this study
Official title: Translational and Clinical Aspects of Metabolic, Anabolic and Endothelial Dysfunction in Herat Failure
In patients with HF cardiac output, metabolism and endothelial function will be studied during and after treatment with ghrelin infusion
Read the 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%.
- Being tested
- Ghrelin, Placebo
- Keywords
- cardiac output
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GhrelinBiological
Ghrelin infusion
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Ghrelin infusion | Active comparator | Ghrelin infusion 30 pmol/kg/min, 0.50 ml/min during 120 minutes Receives: Biological: Ghrelin |
| Placebo | Placebo comparator | Saline 0.50 ml/min during 120 minutes Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiac output between treament groups
Assessed by non-invasive inert gas rebreathing technique (L/min)
Measured: Procedure (At the end of ghrelin administration)
Secondary outcomes (4)
Change in endothelial function between treament groups
Assessed non-invasive by flow mediated dilatory capability of the brachial artery (mm)
Measured: Procedure (At the end of ghrelin administration)
Change in cardiac function between treament groups
Assessed by echocardiography (left ventricular ejection fraction, strain, TAPSE)
Measured: Procedure (At the end of ghrelin administration)
GH biomarker
Circulating biomarkers (GH)
Measured: Procedure (At the end of ghrelin administration)
ghrelin biomarker
Circulating biomarkers ( ghrelin)
Measured: Procedure (At the end of ghrelin administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start17 Feb 2013
- Primary completion22 May 2014
- Study completion22 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Reduced Ejection Fraction HFrEFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized, parallellel intervention study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lars Lund
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lars Lund, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277415
- Sponsor's protocol ID
- 2008/1:12
- Acronym
- MetAnEnd-HF
- Status last verified
- Oct 2024
- First submitted
- 25 Jan 2022
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lund LH, Hage C, Pironti G, Thorvaldsen T, Ljung-Faxen U, Zabarovskaja S, Shahgaldi K, Webb DL, Hellstrom PM, Andersson DC, Stahlberg M. Acyl ghrelin improves cardiac function in heart failure and increases fractional shortening in cardiomyocytes without calcium mobilization. Eur Heart J. 2023 Jun 9;44(22):2009-2025. doi: 10.1093/eurheartj/ehad100.
PubMed 36916707
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational and Clinical Aspects of Metabolic, Anabolic and Endothelial Dysfunction in Herat Failure
- ClinicalTrials.gov ID
- NCT05277415
- Acronym / sponsor ID
- MetAnEnd-HF / 2008/1:12
- Keywords
- cardiac output
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Lars LundUniversity, hospital or other
- Study start
- 17 Feb 2013 (actual)
- Primary completion
- 22 May 2014 (actual)
- Study completion
- 22 May 2014 (actual)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, randomized, parallellel intervention study
| Arm | Type | Receives |
|---|---|---|
| Ghrelin infusion | Active comparator | Biological: GhrelinGhrelin infusion 30 pmol/kg/min, 0.50 ml/min during 120 minutes |
| Placebo | Placebo comparator | Biological: PlaceboSaline 0.50 ml/min during 120 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Current or past signs of clinical HF according to the Framingham criteria
- LVEF<40%
- NT-proBNP > 300 ng/L
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GhrelinGhrelin infusion | Biological | Ghrelin infusion |
| PlaceboPlacebo | Biological | Placebo |
Primary outcome
Change in cardiac output between treament groups
Time frame: Procedure (At the end of ghrelin administration)
Assessed by non-invasive inert gas rebreathing technique (L/min)
4 secondary outcomes
Change in endothelial function between treament groups
Time frame: Procedure (At the end of ghrelin administration)
Change in cardiac function between treament groups
Time frame: Procedure (At the end of ghrelin administration)
GH biomarker
Time frame: Procedure (At the end of ghrelin administration)
ghrelin biomarker
Time frame: Procedure (At the end of ghrelin administration)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Derived from this study: PubMed 36916707Lund LH, Hage C, Pironti G, Thorvaldsen T, Ljung-Faxen U, Zabarovskaja S, Shahgaldi K, Webb DL, Hellstrom PM, Andersson DC, Stahlberg M. Acyl ghrelin improves cardiac function in heart failure and increases fractional shortening in cardiomyocytes without calcium mobilization. Eur Heart J. 2023 Jun 9;44(22):2009-2025. doi: 10.1093/eurheartj/ehad100.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ghrelin in people with Heart Failure With Reduced Ejection Fraction HFrEF, run by Lars Lund.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiac output between treament groups (time frame: Procedure (At the end of ghrelin administration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05277415, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.