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Cardiac Metabolic Profiling in the Fed State

Cardiac Metabolic Profiling in the Fed State

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05460572
Acronym
CAMP
Enrollment
30
Registered
2022-07-15
Start date
2022-07-01
Completion date
2024-01-01
Last updated
2022-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Cardiac Metabolism, Arteriovenous gradient, Metabolites, Fed State, Heart Failure

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.

Interventions

DIETARY_SUPPLEMENTPeripheral Parental Nutrition

Peripheral parenteral nutrition (PPN) through an intravenous (iv) line

Sponsors

Netherlands Heart Foundation
CollaboratorOTHER
University Medical Center Groningen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Quantitative analysis of cardiac uptake and release of metabolites in the fed statePeripheral Parental Nutrition will start before start of the PVI procedure. Sixty minutes after start of peripheral parental nutrition, blood sampling will be performed.Cardiac fuel use will be mapped by metabolomics on blood from the left atrium, the coronary sinus and the right atrium during PVI procedure. By comparing the concentrations of metabolites in the blood from different anatomical locations, cardiac uptake or release of energy substrates will be determined.

Secondary

MeasureTime frameDescription
Quantitative analysis of uptake and release of metabolites in the fed state in the lower extremityPeripheral Parental Nutrition will start before start of the PVI procedure. Sixty minutes after start of peripheral parental nutrition, blood sampling will be performed.Fuel use will be mapped by metabolomics on blood from the left atrium and the femoral vein during PVI procedure. By comparing the concentrations of metabolites in the blood from different anatomical locations, the uptake or release of metabolites by the lower extremity will be determined. Comparisons will be made between arterial blood (left atrium) and venous blood from the leg (femoral vein), in order to quantify extraction or secretion of each metabolite.
Differences in cardiac uptake and release of metabolites between heart failure patients with reduced, mid-range and preserved ejection fraction and patients without HFPeripheral Parental Nutrition will start before start of the PVI procedure. Sixty minutes after start of peripheral parental nutrition, blood sampling will be performed.Cardiac fuel use will be mapped by metabolomics on blood from the left atrium, the coronary sinus and the right atrium during PVI procedure. By comparing the concentrations of metabolites in the blood from different anatomical locations, cardiac uptake or release of energy substrates will be determined. To determine differences in arteriovenous gradients between HF with reduced, mid-range and preserved ejection fraction versus patients without HF, patients will be assigned to one of the following four groups based on available information about presence of heart disease and most recently documented ejection fraction in the EPD.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026