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Understanding the small vessels in the lungs and their function with a novel method of lung microvascular assessment in healthy patients and those with pulmonary hypertension.

INvasive aSsessment of Pulmonary microvascular function with novel Indices of pulmonary flow REserve and pulmonary microcirculatory REsistance – The INSPIRE study.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001279415
Acronym
INSPIRE
Enrollment
4
Registered
2025-11-17
Start date
2025-05-21
Completion date
2026-12-31
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Pulmonary hypertension affects many people worldwide and can severely reduce quality of life and shorten lifespan. The disease begins in the lung’s tiny blood vessels (the microcirculation), which are invisible on routine tests. The current gold-standard test, right heart catheterisation, cannot measure microcirculatory function and often detects disease only after damage is established. This study will (1) determine whether a new, invasive method to assess lung microcirculation is feasible to use in practice, and (2) establish normal values in healthy adults. By identifying microcirculatory problems in the lungs earlier, we aim to enable earlier, more effective treatment.

Interventions

Healthy controls and participants with Group 1 pulmonary arterial hypertension will undergo a novel invasive pulmonary microcirculation study utilising continuous thermodilution methodology within the pulmonary circulation. This procedure will be performed once in each individual by an experienced procedural Cardiologist at a quaternary pulmonary hypertension and advanced heart failure referral centre. The procedure involves a standard right heart catheterisation then follow on to indices of p

Healthy controls and participants with Group 1 pulmonary arterial hypertension will undergo a novel invasive pulmonary microcirculation study utilising continuous thermodilution methodology within the pulmonary circulation. This procedure will be performed once in each individual by an experienced procedural Cardiologist at a quaternary pulmonary hypertension and advanced heart failure referral centre. The procedure involves a standard right heart catheterisation then follow on to indices of pulmonary microvascular function procedure via a multipurpose catheter placed in the left or right pulmonary artery and a Hexacath Rayflow microcatheter and Abbott PressureWireX placed in a subsegmental pulmonary artery. Absolute pulmonary artery flow and microvascular resistance are calculated by use of continuous thermodilation methodology using normal saline attached to RayFlow catheter via injector enabling constant pressure and flow delivery. Each participant undergoes the procedure one time, with procedural duration of approximately 30 minutes. Participation in the study ends after the procedure is completed, there is no further follow up. As this is a once off procedure, there is no risk of participant non-adherence. Each procedure will be conducted in accordance with a strict, standardised protocol developed by the investigative team. Only trained procedural cardiologists who have completed specific competency-based instruction in the study protocol will perform the procedure.

Sponsors

Alfred Health
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

Inclusion criteria for Healthy Controls: - Aged 18 to 75 years - Body mass index (BMI) between 20 to 35kg/m2 - estimated glomerular filtration rate (eGFR) >60ml/min/m2 - Left ventricular ejection fraction >55% on echocardiogram - No significant coronary artery disease Inclusion criteria for Group 1 pulmonary arterial hypertension (PAH): - Aged 18 to 70 years - Consensus diagnosis of group 1 PAH by two pulmonary hypertension experts. - Right heart catheterisation confirming pre-capillary pulmonary hypertension (mean pulmonary artery pressure >20mmHg, pulmonary capillary wedge pressure 2 Wood units) - BMI between 20 to 40kg/m2

Exclusion criteria

Exclusion criteria for Healthy controls: - Platelet count 1100 ng/L or BNP >800 ng/L - 6MWD <165m - TAPSE/SPAP 14mmHg, CI <2.0 L/min/m2, SvO2 <60% - Inability to provide informed consent - Pregnancy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026