- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02789449
Estimation of Pulmonary Capillary Blood Volume in Pre- and Postcapillary Pulmonary Hypertension
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Steiermark
-
Graz, Steiermark, Østrig, 8010
- Medical University Graz, Division of Pulmonology
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
precapillary
patients with PH and PAWP<12mmHg
|
|
|
postcapillary
patients with PH and PAWP>18mmHg
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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))
Tidsramme: one hour
|
one hour
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 27-203 ex 14-15
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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-
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