TABLE 5

Clinical trials investigating pulmonary artery denervation

干预 ClinicalTrials.govidentifier Study design Study duration Main inclusion criteria Primary outcome measures Secondary outcome measures
Therapeutic Intra-Vascular UltraSound (TIVUS) system NCT02516722 Multicentre open-label study (TROPHY) 12 months PAH in WHO FC III on stable double combination therapy other than parenteral PGI2 Safety (procedure-related AE: 1 month); safety (PAH-related AEs and all-cause death: 12 months) Change in mPAP, PVR, 6MWD and QoL at 4 months
Therapeutic Intra-Vascular UltraSound (TIVUS) system NCT02835950 Multicentre open-label study (TROPHY-US) 12 months PAH in WHO FC III on stable double combination therapy other than parenteral PGI2 Safety (procedure-related AE: 1 month); safety (AEs, PAH-related AEs and all-cause death: 12 months) Change in mPAP, PVR, 6MWD, QoL, NT-proBNP and RV function (MRI and echocardiography) at 6 months
Pulmonary artery denervation NCT02525926 Multicentre single-blinded RCTversus安慰剂(DENERV 'AP) 24周 PAH patients in WHO FC III–IV despite dual therapy including a PGI2or dual oral therapy in patients unable to receive PGI2therapy Change in mPAP (RHC) Change in mPAP (3 months), PVR and other haemodynamic variables (6 months), FC, 6MWD, oxygen dependence, supraventricular arrhythmia, BNP, cardiac troponin, and RV function (echocardiography)
PA denervation (+sildenafil) NCT03282266 Multicentre single-blinded RCTversusplacebo (PADN-CFDA) 24周 PAH Change in 6MWD Change in haemodynamic variables (RHC), RV function (echocardiography) and PAH-related events

多环芳烃:普尔monary arterial hypertension; WHO: World Health Organization; FC: functional class; PGI2: prostacyclin I2; AE: adverse event; mPAP: mean pulmonary arterial pressure; PVR: pulmonary vascular resistance; 6MWD: 6-min walk distance; QoL: quality of life; NT-proBNP: N-terminal pro-brain natriuretic peptide; RV: right ventricle; MRI: magnetic resonance imaging; RCT: randomised controlled trial; RHC: right heart catheterisation.