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Completed

NCT Number: NCT02969486

Non-invasive Estimation of Pulmonary Artery Pressure in Healthy Subjects by Electrical Impedance Tomography

Pulmonary hypertension (PH) is a condition characterized by a sustained elevation in pulmonary artery pressure (PAP) above 25 mmHg assessed by right heart catheterization. PH is fatal in absence of adequate treatment or therapy, as the condition progressively increases the workload of the right heart and ultimately leads to its failure. With a minimal indicative prevalence of 1 case/300, PH affects at least 25'000 people in Switzerland alone. After initiation of PH therapy, the follow-up of the patient's health status is often limited to punctual PAP measurements at the clinic at intervals of several months. The lack of more frequent measurements of the patient's PAP strongly hinders the identification of short-term trends in pulmonary hemodynamics, and therefore the anticipation of worsening conditions or treatment inefficiency. As possible solutions, wireless implantable hemodynamic monitors such as the CardioMEMSTM HF System (CardioMEMS Inc., Atlanta, USA) have recently been introduced for the continuous monitoring of PAP in patients with PH. The benefits of frequent measurements over intermittent clinic visits have been demonstrated in several previous studies, notably in terms of prediction of therapy outcomes, anticipation of worsening heart failure, feedback rapidity during therapy, or decline in hospitalization rates. Nevertheless, despite the undeniable advantages that implantable monitors offer to the patient, they remain highly invasive solutions. In contrast, noninvasive alternatives for the measurement of PAP exist, such as transthoracic echocardiography, but are impractical for frequent PAP assessments due to their dependency on qualified personnel to perform the measurement. An optimal PAP monitoring modality for patients with PH should be non-invasive (free of any risks or complications associated with cardiac catheterization) and unsupervised (able to operate without supervision of a medical doctor). Such a modality does not currently exist. In the present study, the investigators propose and investigate the potential of a novel non-invasive, continuous and unsupervised PAP monitoring approach based on the pulse wave velocity (PWV) principle and the use of electrical impedance tomography (EIT).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inselspital

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy subjects ≥ 18 years old, BMI < 30 kg/m2
  • Good understanding of written and oral German
  • Willing to provide a signed informed consent

Exclusion criteria

  • Pace-maker/ ICD
  • Chronic heart diseases
  • Chronic pulmonary diseases
  • Congenital heart/pulmonary diseases
  • Instable angina pectoris
  • Active alcohol or drug abuse
  • Pregnancy or lactation (women of childbearing age will be asked to performed urinary pregnancy test before the screening phase)

Treatment and study plan

Primary outcomes

  1. Correlation coefficients

    Time frame: Single visit 2 hours

    Assessment of significant subject-wise correlation coefficients between the reference PAP, obtained by the gold Standard transthoracic echocardiography technique, and an EIT-derived PAP-related parameter. The primary outcome is therefore the demonstration of the feasibility of monitoring changes in PAP (intra-subject trending ability) by EIT.

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Prospective Proof-of-concept Study Non-invasive Estimation of Pulmonary Artery Pressure in Healthy Subjects by Electrical Impedance Tomography

Acronym: PAP-EIT

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 21, 2016
Registry last updated
Feb 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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