Clinical trial NCT05460572: Cardiac Metabolic Profiling in the Fed State
Official title: Cardiac Metabolic Profiling in the Fed State
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: Cardiac Metabolism
Arteriovenous gradient
Metabolites
Fed State
Heart Failure
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Netherlands Heart Foundation
First posted: 2022-07-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a non-randomized interventional prospective study, aiming to provide insight into cardiac substrate utilization in the fed state. Patients will participate during an elective PVI procedure which would have taken place regardless of the current study. During this study, study subjects will receive peripheral parenteral nutrition (PPN) through an intravenous (iv) line. During the procedure, blood samples will be drawn from the catheters which will be in situ for the purpose of the elective PVI procedure. Cardiac arteriovenous (A-V) gradients of metabolites will be measured, reflecting cardiac uptake and release of metabolites in the fed state.

Detailed description: The heart requires tremendous amounts of energy to sustain its continuous mechanical work. The heart can utilize various metabolic substrates to generate energy, including carbohydrates, lipids, amino acids and ketone bodies. However, most research on cardiac fuel use has been done in rodents and surprisingly little is known about cardiac fuel use in patients with heart disease. Prior experimental studies showed that carbohydrates are important fuels for cardiac energy production. In contrast, a recent study in patients with heart disease showed that the heart only utilizes little amounts of carbohydrates. This study was however, performed in fasting subjects, which could have an important effect on substrate preference. The primary aim of this non-randomized interventional prospective study is to provide insight into cardiac substrate utilization in the fed state. 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. Blood samples will be drawn with the catheters which will already be in situ for the purpose of the elective PVI procedure. Cardiac arteriovenous (A-V) gradients of metabolites will be measured, reflecting cardiac uptake and release of metabolites in the fed state.

Eligibility criteria: Inclusion Criteria:

* Undergoing elective PVI procedure
* Adult age (≥ 18 years)
* Have given verbal 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 patient's safety while participating in this trial or may prevent the patient from adhering to the trial protocol.

Primary outcomes:
measure: Quantitative analysis of cardiac uptake and release of metabolites in the fed state
timeFrame: Peripheral Parental Nutrition will start before start of the PVI procedure. Sixty minutes after start of peripheral parental nutrition, blood sampling will be performed.
Secondary outcomes:
measure: Quantitative analysis of uptake and release of metabolites in the fed state in the lower extremity
timeFrame: Peripheral Parental Nutrition will start before start of the PVI procedure. Sixty minutes after start of peripheral parental nutrition, blood sampling will be performed.
measure: Differences in cardiac uptake and release of metabolites between heart failure patients with reduced, mid-range and preserved ejection fraction and patients without HF
timeFrame: Peripheral Parental Nutrition will start before start of the PVI procedure. Sixty minutes after start of peripheral parental nutrition, blood sampling will be performed.
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Universitary Medical Center Groningen
Study officials:
affiliation: Universitary Medical Center Groningen
name: Daan Westenbrink, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: