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

NCT02789449 | Completed

• 1 other identifier: 27-203 ex 14-15
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension Pulmonary

Outcome Measures

Primary Outcomes (1)

• 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))

  one hour

Study Arms (2)

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

Interventions

assessment of DLNO and DLCO OTHER

postcapillary; precapillary

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with PH

You may qualify if:

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

You may not qualify if:

• patients unable to perform the DLCO test

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University Graz, Division of Pulmonology

Graz, Styria, 8010, Austria

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Horst Olschewski, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: June 3, 2016
• Study Start: November 1, 2015
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)