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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
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 5, 2022
Last Updated
July 11, 2022
Sponsor
University Medical Center Groningen
Collaborators
Netherlands Heart Foundation
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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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