Estimation of Pulmonary Capillary Blood Volume in Pre- and Postcapillary Pulmonary Hypertension

March 17, 2020 updated by: Medical University of Graz

Non-invasive Estimation of Pulmonary Capillary Blood Volume in Pre- and Postcapillary Pulmonary Hypertension - a Pilot Study

The aim of the study is to investigate the role of the non-invasive assessment of nitric oxyde (NO) diffusion capacity (DLNO) in the differential diagnosis of different forms of pulmonary hypertension (PH). DLNO alone and in combination with the measurement of carbon monoxide (CO) diffusion capacity (DLCO) may help to differentiate between pre- and postcapillary forms of pulmonary hypertension. This hypothesis is based on the fact that NO has a much higher affinity to hemoglobin as compared to CO and may therefore its decrease may more specifically identify the limiting factors between the alveolar space and the lung capillaries including left heart failure (cardiac edema).

As there are no available published data yet to answer this question investigators aim to perform a small pilot study. The results of this study may allow the planning of a prospective study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

17

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

  • Austria
    • Steiermark
      • Graz, Steiermark, Austria, 8010
        • Medical University Graz, Division of Pulmonology

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

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with PH

Description

Inclusion Criteria:

  • patients undergoing right heart catheterization
  • patients with clear precapillary PH (PAWP<12mmHg) or clear postcapillary PH (PAWP>18mmHg)
  • signed informed consent

Exclusion Criteria:

  • patients unable to perform the DLCO test

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
precapillary
patients with PH and PAWP<12mmHg
Other: assessment of DLNO and DLCO
postcapillary
patients with PH and PAWP>18mmHg
Other: assessment of DLNO and DLCO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in DLNO (in mmol/min/kPa) between the two predefined groups (patients with clear precapillary PH (PAWP<12mmHg) vs. clear postcapillary PH (PAWP>18mmHg))
Time Frame: one hour
one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

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

November 1, 2015

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

April 22, 2016

First Submitted That Met QC Criteria

May 30, 2016

First Posted (Estimate)

June 3, 2016

Study Record Updates

Last Update Posted (Actual)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27-203 ex 14-15

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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