- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02969486
Non-invasive Estimation of Pulmonary Artery Pressure in Healthy Subjects by Electrical Impedance Tomography (PAP-EIT)
February 1, 2017 updated by: University Hospital Inselspital, Berne
Prospective Proof-of-concept Study 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).
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bern, Switzerland, 3010
- Inselspital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Healthy subjects ≥ 18 years old
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Correlation coefficients
Time Frame: Single visit 2 hours
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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.
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Single visit 2 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Stefano Rimoldi, Prof, University Hospital Inselspital, Berne
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M; ESC Scientific Document Group. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Heart J. 2016 Jan 1;37(1):67-119. doi: 10.1093/eurheartj/ehv317. Epub 2015 Aug 29. No abstract available.
- Strange G, Playford D, Stewart S, Deague JA, Nelson H, Kent A, Gabbay E. Pulmonary hypertension: prevalence and mortality in the Armadale echocardiography cohort. Heart. 2012 Dec;98(24):1805-11. doi: 10.1136/heartjnl-2012-301992. Epub 2012 Jul 3.
- McGoon MD, Kane GC. Pulmonary hypertension: diagnosis and management. Mayo Clin Proc. 2009 Feb;84(2):191-207. doi: 10.1016/S0025-6196(11)60828-8. Erratum In: Mayo Clin Proc. 2009 Apr;84(4):386.
- Abraham WT, Adamson PB, Bourge RC, Aaron MF, Costanzo MR, Stevenson LW, Strickland W, Neelagaru S, Raval N, Krueger S, Weiner S, Shavelle D, Jeffries B, Yadav JS; CHAMPION Trial Study Group. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet. 2011 Feb 19;377(9766):658-66. doi: 10.1016/S0140-6736(11)60101-3. Erratum In: Lancet. 2012 Feb 4;379(9814):412.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (ACTUAL)
December 1, 2016
Study Completion (ACTUAL)
December 1, 2016
Study Registration Dates
First Submitted
November 17, 2016
First Submitted That Met QC Criteria
November 18, 2016
First Posted (ESTIMATE)
November 21, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
February 2, 2017
Last Update Submitted That Met QC Criteria
February 1, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 2016-00747
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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