Table 2.
Clinical Trials in Pulmonary Hypertension. 6MWD: 6-minute walk distance. DCA: dichloroacetate. 18FDG: 18F-fluorodeoxyglucose. PAP: pulmonary artery pressure. PAOP: pulmonary artery wedge pressure. PASP: pulmonary artery systolic pressure. PVR: pulmonary vascular resistance. MRI: magnetic resonance imaging. RVEF: right ventricular ejection fraction.
| Therapy | Clinical Trial Identification | Design | Primary Endpoints | Treatment Duration | Status as of Publication |
|---|---|---|---|---|---|
| Dichloroacetate Sodium | NCT01083524 | Phase I, interventional, open-label, non-randomized in idiopathic, familial, or anorexigen-associated PAH patients | Safety and tolerability of DCA | 16 weeks | Completed September 2013 [unpublished] |
| Ferric carboxymaltose | NCT01288651 | Phase IV, interventional, open-label, single group assignment in iron deficient patients with idiopathic PAH | Change in 6MWD | 12 weeks | Completed [58] |
| Ferric carboxymaltose | NCT01847352 | Single-blind, interventional, non-randomized in iron-deficient and iron-replete healthy volunteers | Change in PASP under subacute hypoxia with and without prior intravenous iron infusion | 6 hours | Completed [59] |
| Ferric carboxymaltose (Europe) or Iron Dextran (China) | NCT01447628 | Phase II, interventional, randomized, double-blind in patients with idiopathic, heritable, or anorexigen-associated PAH | Change in PVR and exercise capacity | 12 weeks | Recruiting |
| Observing Low Fe-S Clusters | NCT02594917 | Observational, cohort, prospective in patients with low Fe-S clusters | Change in 6MWD and PAP | — | Recruiting |
| Metformin | NCT01352026 | Phase II, interventional, single group assignment, open-label in patients with PAH | — | — | Withdrawn due to lack of recruiting |
| Metformin | NCT01884051 | Observational, cohort, prospective and Phase I, interventional in patients with idiopathic, heritable, scleroderma-, or anorexigen-associated PAH | Safety and tolerability of metformin (& secondary efficacy outcome measures) | — | Recruiting |
| Tacrolimus | NCT01647945 | Phase II, interventional, randomized, double-blind in Group I PAH patients | Safety of low-dose tacrolimus (& 6MWD as secondary outcome) | 18 weeks | Completed [unpublished] |
| Bardoxolone methyl | NCT02036970 | Phase II, interventional, randomized, parallel assignment in PAH | Change in 6MWD | 16 weeks | Ongoing |
| Ranolazine | NCT01174173 | Phase III, interventional, single group assignment, open-label in patients with angina and PAH | Change in angina symptoms, 6MWD, and quality of life | 3 months | Completed [185] |
| Ranolazine | NCT02133352 | Phase IV, interventional, single group assignment, open-label in Group II PH patients | Change in mean PAP, PAOP, and PVR | 6 months | Completed [unpublished] |
| Ranolazine | NCT01839110 | Interventional, randomized, double-blind in subjects on stable PH therapies with RV dysfunction (RVEF <45%) | Number and percentage of subjects with high risk profile | 26 weeks | Ongoing |
| Ranolazine | NCT02829034 | Interventional, randomized, double-blind in subjects on stable PH therapies with RV dysfunction (RVEF <45%) | Percent change in RVEF as measured by MRI | 26 weeks | Recruiting |
| Ranolazine 11C-Acetate 18FDG |
NCT01917136 | Phase II, interventional, single group assignment, open-label in PH patients with and without RV dysfunction | Change in myocardial oxygen consumption, 18FDG uptake, and myocardial perfusion | 26 weeks | Ongoing |
| Trimetazidine | NCT02102672 | Phase II, interventional, randomized, double-blind in Group I PAH patients | Changes in RV function assessed by echo 3d | 3 months | Recruiting |