Mapping of Cardiac Power in Healthy Humans and Testing of a New Blood Pressure Sensor

NCT05008133 | Completed

• 2 other identifiers: 62226CIV-NO-21-04-036325
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Summary: The study will record hemodynamic data from 20 healthy volunteers at rest and during moderate bicycle exercise in the recumbent and half sitting position for the following purposes: Sub-study 1 Testing the overall accuracy and the dependence on changes in posture and exercise of a new non-invasive blood pressure sensor against simultaneous invasive measurements. Sub-study 2 Exploration of the effect of exercise and position on cardiac energy delivery to the circulation. The interplay between heart and vasculature (Ventriculo-arterial coupling) will be characterized based on simultaneous blood pressure and ultrasound blood flow measurements. Sub-study 3 Evaluation and possible improvement of an individualized mechanistic model predicting the hemodynamic response to exercise based on hemodynamic profile at rest. Sub-study 4 Testing of a machine learning based system for evaluation of dynamic autoregulation of renal blood flow from simultaneous continuous blood pressure and ultrasound blood flow measurements.

Conditions

Healthy Volunteers

Keywords

Blood pressure monitoring; Cardiac Power; Dynamic autoregulation of renal blood flow; Personalized hemodynamic modelling

Outcome Measures

Primary Outcomes (4)

• The ability of the new non-invasive blood pressure sensor to correctly represent the invasive blood pressure measurements independent of changes in posture and activity

  The correspondence between paired beat-to-beat numeric values for non-invasive and invasive systolic, diastolic, and mean arterial pressures (all given in mmHg) will be used to determine the new device's overall accuracy. The effects of posture and activity on the new sensor's accuracy will be assessed by comparing the non-invasive blood pressure measurements correspondence with the invasive ones at the different posture and exercise levels. Standard criteria for comparison of clinical measurements with different methods will be applied

  The last 2 minutes of each exercise step

• The effects of posture and activity on energy transfer from the heart to the vasculature

  This will be assessed by comparing the values obtained for Total Cardiac Power, Cardiac Power Output and Oscillatory Power (all measured in Watts) at rest and during bicycle exercise of 50, 100 and 150 watts in the recumbent and half sitting positions.

  The last 30 seconds of each exercise step

• The degree of correctly predicted individual hemodynamic responses to exercise by the mechanistic model in a cohort of healthy humans.

  The model's ability to predict individual hemodynamic responses to posture and exercise challenges will be tested by comparison of predicted and recorded hemodynamic profiles including the following interlinked measured variables: 1. Blood-pressures: systolic, diastolic and mean arterial pressure (all measured in mmHg). 2. Heart Rate (beats/minute) 3. Blood flow: Stroke volume (ml/beat)

  The last 30 seconds of each exercise step

• The ability of machine learning assisted ultrasound recordings of flow signals from renal arteries combined with simultaneous blood pressure measurements to identify Dynamic Autoregulation of Renal Blood Flow mechanisms.

  The different machine learning methods and transfer function analysis approaches will be evaluated by their ability to identify normal MR and TGF signals in frequency plots produced by transfer function analyses of four minutes continuous recordings of blood pressure and renal artery flow signals from normal subjects.

  Four minutes recording at rest

Interventions

Bicycle exercise BEHAVIORAL

Stepwise increased exercise for 5 minutes at 0, 50, 100 and 150 Watts. One series lying flat in prone position, after 15 minutes of rest, series repeated at 70 degrees head up tilt.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

You may qualify if:

• Healthy
• Volunteers

You may not qualify if:

• Diabetes mellitus
• Cardio-vascular disease
• Increased risk of thrombo-embolism
• Not capable to participate due to muscular or skeletal disease or dementia
• Low blood flow in arteria ulnaris

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

St Olavs Hospital,

Trondheim, Trøndelag, 7006, Norway

Location

Study Officials

• Idar Kirkeby-Garstad, Md, PhD

  Dept of Anesthesia and Intensive Care, St Olavs Hospital

  PRINCIPAL INVESTIGATOR

• Hilde Pleym, MD PhD

  Dept of Anesthesia and Intensive Care, St Olavs Hospital

  STUDY CHAIR

• Øystein Risa

  NTNU, Department of Circulation and Imaging

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: August 17, 2021
• Study Start: May 14, 2021
• Primary Completion: November 4, 2021
• Study Completion: November 4, 2021
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)