Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398964
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2023-08-23
Brief Title:
Effects of 2-week Ketosis on the Hearts Ketone Body Consumption Utilization and Energetic Efficiency in Patients With Chronic Heart Failure
Sponsor:
Aarhus University Hospital
Organization:
Aarhus University Hospital
Study Overview
Official Title:
Effects of 2-week Ketosis on Myocardial Ketone Body Consumption Utilization and External Efficiency in Patients With Chronic Heart Failure
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KETO-CHF PET
Brief Summary:
Heart Failure HF is a significant health concern affecting around 1-2 of people in Western countries The risk of developing HF during a lifetime is about 20 Despite advancements in HF care the one-year mortality rate for HF patients remains high HF patients also experience reduced physical capacity and quality of life The heart relies heavily on a process called oxidative metabolism for energy and this process requires a continuous supply of energy sources like fatty acids glucose and ketone bodies In HF theres a shift in how the heart uses these energy sources which affects its efficiency
Ketone bodies such as 3-OHB are molecules that can provide the heart with a more efficient energy source compared to traditional ones like fatty acids or glucose They are produced in the liver and are important for supplying energy during fasting exercise and illness Recent research suggests that 3-OHB might have benefits for HF patients beyond just providing energy It seems to reduce inflammation and oxidative stress in the heart Some studies in healthy individuals have shown that infusing 3-OHB increases blood flow to the heart
In HF patients the investigators aim to explore the cardiac effects of a two-week supplement of 3-OHB The aim is to investigate if this supplement can increase the hearts consumption and utilization of 3-OHB The study involves 12 patients with HF and reduced ejection fraction HFrEF The patients will receive a ketone ester supplement four times a day for two weeks and then theyll take an isocaloric placebo supplement for another two weeks
The investigators will use positron emission tomography PET to study the cardiac oxygen consumption and 3-OHB uptake This is done by injection of tracers 11-C-3-OHB and 11-C-acetate
The study will also look at myocardial external efficiency MEE and myocardial blood flow MBF For a subset of participants the investigators will also take myocardial biopsies and perform more detailed analyses eg respirometry and electron microscopy or single nucleus mRNA sequencing proteomics and metabolimcs to understand the impact of the supplement on the hearts cellular structures and functions transcriptome proteome and metabolome
Ultimately this study aims to determine whether supplementing HF patients with 3-OHB can improve the hearts energy usage and potentially provide other beneficial effects This research might pave the way for new treatments that enhance the hearts function and quality of life for HF patients
Ketone bodies such as 3-OHB are molecules that can provide the heart with a more efficient energy source compared to traditional ones like fatty acids or glucose They are produced in the liver and are important for supplying energy during fasting exercise and illness Recent research suggests that 3-OHB might have benefits for HF patients beyond just providing energy It seems to reduce inflammation and oxidative stress in the heart Some studies in healthy individuals have shown that infusing 3-OHB increases blood flow to the heart
In HF patients the investigators aim to explore the cardiac effects of a two-week supplement of 3-OHB The aim is to investigate if this supplement can increase the hearts consumption and utilization of 3-OHB The study involves 12 patients with HF and reduced ejection fraction HFrEF The patients will receive a ketone ester supplement four times a day for two weeks and then theyll take an isocaloric placebo supplement for another two weeks
The investigators will use positron emission tomography PET to study the cardiac oxygen consumption and 3-OHB uptake This is done by injection of tracers 11-C-3-OHB and 11-C-acetate
The study will also look at myocardial external efficiency MEE and myocardial blood flow MBF For a subset of participants the investigators will also take myocardial biopsies and perform more detailed analyses eg respirometry and electron microscopy or single nucleus mRNA sequencing proteomics and metabolimcs to understand the impact of the supplement on the hearts cellular structures and functions transcriptome proteome and metabolome
Ultimately this study aims to determine whether supplementing HF patients with 3-OHB can improve the hearts energy usage and potentially provide other beneficial effects This research might pave the way for new treatments that enhance the hearts function and quality of life for HF patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None