TABLE 5.
Clinical trials investigating pulmonary artery denervation
| Intervention | ClinicalTrials.gov identifier | 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 RCT versus placebo (DENERV'AP) | 24 weeks | PAH patients in WHO FC III–IV despite dual therapy including a PGI2 or dual oral therapy in patients unable to receive PGI2 therapy | 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 RCT versus placebo (PADN-CFDA) | 24 weeks | PAH | Change in 6MWD | Change in haemodynamic variables (RHC), RV function (echocardiography) and PAH-related events |
PAH: pulmonary 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.