Cardiac Metabolic Profiling in the Fed State (CAMP)
Primary Purpose
Heart Failure
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Peripheral Parental Nutrition
Sponsored by
About this trial
This is an interventional other trial for Heart Failure focused on measuring Cardiac Metabolism, Arteriovenous gradient, Metabolites, Fed State, Heart Failure
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.
Sites / Locations
- Universitary Medical Center Groningen
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients undergoing PVI procedure and who are treated with peripheral parental nutrition
Arm Description
Patients undergoing elective PVI procedure who will receive peripheral parental nutrition before start of the procedure.
Outcomes
Primary Outcome Measures
Quantitative analysis of cardiac uptake and release of metabolites in the fed state
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 Outcome Measures
Quantitative analysis of uptake and release of metabolites in the fed state in the lower extremity
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 HF
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.
Full Information
NCT ID
NCT05460572
First Posted
July 5, 2022
Last Updated
July 11, 2022
Sponsor
University Medical Center Groningen
Collaborators
Netherlands Heart Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05460572
Brief Title
Cardiac Metabolic Profiling in the Fed State
Acronym
CAMP
Official Title
Cardiac Metabolic Profiling in the Fed State
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
July 15, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medical Center Groningen
Collaborators
Netherlands Heart Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Cardiac Metabolism, Arteriovenous gradient, Metabolites, Fed State, Heart Failure
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients undergoing PVI procedure and who are treated with peripheral parental nutrition
Arm Type
Other
Arm Description
Patients undergoing elective PVI procedure who will receive peripheral parental nutrition before start of the procedure.
Intervention Type
Dietary Supplement
Intervention Name(s)
Peripheral Parental Nutrition
Intervention Description
Peripheral parenteral nutrition (PPN) through an intravenous (iv) line
Primary Outcome Measure Information:
Title
Quantitative analysis of cardiac uptake and release of metabolites in the fed state
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Quantitative analysis of uptake and release of metabolites in the fed state in the lower extremity
Description
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.
Time Frame
Peripheral Parental Nutrition will start before start of the PVI procedure. Sixty minutes after start of peripheral parental nutrition, blood sampling will be performed.
Title
Differences in cardiac uptake and release of metabolites between heart failure patients with reduced, mid-range and preserved ejection fraction and patients without HF
Description
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.
Time Frame
Peripheral Parental Nutrition will start before start of the PVI procedure. Sixty minutes after start of peripheral parental nutrition, blood sampling will be performed.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daan Westenbrink, MD PhD
Organizational Affiliation
Universitary Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitary Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
12. IPD Sharing Statement
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Cardiac Metabolic Profiling in the Fed State
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