TABLE 5

Clinical trials investigating pulmonary artery denervation

InterventionClinicalTrials.gov identifierStudy designStudy durationMain inclusion criteriaPrimary outcome measuresSecondary outcome measures
Therapeutic Intra-Vascular UltraSound (TIVUS) systemNCT02516722Multicentre open-label study (TROPHY)12 monthsPAH in WHO FC III on stable double combination therapy other than parenteral PGI2Safety (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) systemNCT02835950Multicentre open-label study (TROPHY-US)12 monthsPAH in WHO FC III on stable double combination therapy other than parenteral PGI2Safety (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 denervationNCT02525926Multicentre single-blinded RCT versus placebo (DENERV'AP)24 weeksPAH patients in WHO FC III–IV despite dual therapy including a PGI2 or dual oral therapy in patients unable to receive PGI2 therapyChange 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)NCT03282266Multicentre single-blinded RCT versus placebo (PADN-CFDA)24 weeksPAHChange in 6MWDChange 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.