Cardiac Metabolic Profiling in the Fed State

NCT ID: NCT05460572

Last Updated: 2022-07-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2024-01-01

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients undergoing PVI procedure and who are treated with peripheral parental nutrition

Patients undergoing elective PVI procedure who will receive peripheral parental nutrition before start of the procedure.

Group Type: OTHER

Peripheral Parental Nutrition

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Peripheral Parental Nutrition

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

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Netherlands Heart Foundation

OTHER

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daan Westenbrink, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Universitary Medical Center Groningen

Locations

Universitary Medical Center Groningen

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

202100291

Identifier Type: -

Identifier Source: org_study_id