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

NCT02969486 | Completed DMC

• 1 other identifier: 2016-00747
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Pulmonary Artery Pressure

Outcome Measures

Primary Outcomes (1)

• Correlation coefficients

  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.

  Single visit 2 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy subjects ≥ 18 years old

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital

Bern, 3010, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 26320113 BACKGROUND

• 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.

  PMID: 22760869 BACKGROUND

• McGoon MD, Kane GC. Pulmonary hypertension: diagnosis and management. Mayo Clin Proc. 2009 Feb;84(2):191-207. doi: 10.4065/84.2.191.

  PMID: 19181654 BACKGROUND

• 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.

  PMID: 21315441 BACKGROUND

Study Officials

• Stefano Rimoldi, Prof

  Insel Gruppe AG, University Hospital Bern

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 21, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 2, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)