The primary aim of this study is to provide insight into cardiac substrate utilization in the fed state.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cardiac arteriovenous (A-V) gradient of metabolites, reflecting uptake and
release of metabolites in the heart in the fed state.
Secondary outcome
To be determined metabolites
Background summary
The heart requires tremendous amounts of energy to sustain its mechanical work.
The heart can utilize various metabolic substrates to generate energy,
including carbohydrates, lipids, amino acids and ketone bodies. However, most
research into the cardiac fuel usage has been done in rodents and surprisingly
little is known about the cardiac fuel use in patients with heart disease. A
recent study in patients with heart disease showed that the heart mainly uses
fatty acids as a fuel source and only minute amounts of glucose. This study
was, however, performed in fasting subjects; which could have an important
effect on substrate preference.
Study objective
The primary aim of this study is to provide insight into cardiac substrate
utilization in the fed state.
Study design
Monocenter non-randomized intervention study.
Intervention
Administration of peripheral parenteral nutrition (PPN) via a peripheral line.
Determination of metabolites will be done via arteriovenous sampling from the
already placed catheters.
Study burden and risks
Patients will participate during an elective PVI procedure which would have
taken place regardless of the current study. During this study they will
receive peripheral parenteral nutrition PPN) through an intravenous (iv) line
that is already in place for the procedure. In some cases the anesthesiologist
may choose for practical reasons to place an extra iv line, however, this is
not necessary for participation in this study. Per patient this will lead to a
maximum volume load of 750 ml. Patients will not have to pay an extra visit to
the hospital for the purpose of this study and this study will not prolong the
total procedure time. Subjects do not have direct benefits from participating
in this study.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
Adult (>18 years old) undergoing elective pulmonary vein isolation (PVI)
Give verbral and written informed consent
Exclusion criteria
Chronic renal disease with an estimated glomerular filtration rate (eGFR) <30
mL/min/1.73 m2
Chronic liver disease and/or severe liver dysfunction with ASAT and/or ALAT >
3x the upper limit of normal (ULN)
Pregnancy or breastfeeding
Insulin dependent diabetics
Congenital metabolic disease
Weight below 40 kg
Inability to understand and read Dutch or English
Known allergy or hypersensitivity to any of the non-investigational products in
the study protocol
Any other clinical condition that would jeopardize patients safety while
participating in this trial, or may prevent the patient from adhering to the
trial protocol.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77502.042.21 |