NCT05460572

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

July 15, 2022

Status Verified

July 1, 2022

Enrollment Period

1 year

First QC Date

July 5, 2022

Last Update Submit

July 11, 2022

Conditions

Heart Failure

Keywords

Cardiac MetabolismArteriovenous gradientMetabolitesFed StateHeart Failure

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 (2)

  • Quantitative analysis of uptake and release of metabolites in the fed state in the lower extremity

    Peripheral Parental Nutrition will start before start of the PVI procedure. Sixty minutes after start of peripheral parental nutrition, blood sampling will be performed.

  • Differences in cardiac uptake and release of metabolites between heart failure patients with reduced, mid-range and preserved ejection fraction and patients without HF

    Peripheral Parental Nutrition will start before start of the PVI procedure. Sixty minutes after start of peripheral parental nutrition, blood sampling will be performed.

Study Arms (1)

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

OTHER

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

Dietary Supplement: Peripheral Parental Nutrition

Interventions

Peripheral Parental NutritionDIETARY_SUPPLEMENT

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

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing elective PVI procedure
  • Adult age (≥ 18 years)
  • Have given verbal and written informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitary Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Daan Westenbrink, MD PhD

    Universitary Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2022

First Posted

July 15, 2022

Study Start

July 1, 2022

Primary Completion

July 15, 2023

Study Completion

January 1, 2024

Last Updated

July 15, 2022

Record last verified: 2022-07

Locations

NL(1)