Table 1.
Ongoing clinical trials in patients with HFpEF
| Treatment | Clinical trial identifier | Estimated enrollment, phase | Objective | Primary outcome |
|---|---|---|---|---|
| LCZ696 (neprilysin inhibitor) | NCT01920711 | n=4,300 Phase III |
To evaluate the effect of LCZ696 compared to valsartan in the reduction of CV death and HF hospitalizations | Cumulative number of primary composite events of CV death and total (first and recurrent) HF hospitalizations |
| Vericiguat (soluble guanylate cyclase stimulator) | NCT01951638 | n=477 Phase II |
To find the optimal dose of once daily oral soluble guanylate cyclase stimulator | Change of log-transformed NT-proBNP and left atrial volume |
| Anakinra (IL-1 receptor antagonist) | NCT02173548 | n=60 Phase II |
To determine effects on CV function of anti-inflammatory IL-1 blockade | Absolute changes in aerobic exercise capacity (peak VO2) after 12 weeks and absolute changes in VE/VCO2 after 12 weeks treatment |
| Udenafil (phosphodiesterase 5 inhibitor) | NCT01599117 | n=52 Phase III |
To determine if udenafil will improve symptoms, exercise capacity, and hemodynamic status in HFpEF | Change of maximal VO2 in cardiopulmonary exercise test |
| Furosemide ± dopamine | NCT01901809 | n=120 Phase IV |
To test the hypothesis that changing the method of diuresis (continuous vs bolus) with or without low-dose dopamine will reduce renal injury | Change in glomerular filtration rate at 72 hours |
| Isosorbide dinitrate ± hydralazine | NCT01516346 | n=54 Phase II |
To test effect of prolonged isosorbide dinitrate ± hydralazine therapy (24 weeks) on arterial wave reflections | Change in late systolic load from wave reflections between baseline and after 24 weeks of randomized therapy |
| Inorganic nitrate | NCT02256345 | n=12 Phase II |
To determine the safety, tolerability, and dose–response to inorganic nitrate on exercise capacity in HFpEF | Change in peak VO2 from baseline to the end of 1 week of administration for each dose |
| Inhaled sodium nitrite | NCT02262078 | n=30 Phase II |
To assess the effects of nebulized inhaled nitrite administration on resting and exercise hemodynamics | Exercise pulmonary capillary wedge pressure |
| Ranolazine | NCT01505179 | n=40 | To determine whether treatment with ranolazine will improve exercise capacity | Change in exercise capacity from baseline at 6 weeks |
| Nifedipine | NCT01157481 | n=226 | To determine if nifedipine can improve HF clinical response | HF clinical composite response endpoint |
| Nebivolol | NCT02053246 | n=40 Phase IV |
To determine if nebivolol will improve disease severity in patients with pulmonary hypertension associated with HFpEF | Changes in pulmonary vascular pressure |
| Carvedilol vs nebivolol | NCT02619526 | n=62 | To compare the relative effectiveness of carvedilol and nebivolol in treating HF in aged patients with preserved EF | Ratio of transmitral E velocity to early diastolic mitral annular velocity (E/E) |
| Static handgrip, dexmedetomidine, glycopyrrolate, isoproterenol | NCT02524145 | n=45 | To determine the mechanisms of chronotropic incompetence in patients with HFpEF | Cardiac beta-receptor sensitivity |
Abbreviations: CV, cardiovascular; HF, heart failure; NT-proBNP, N-terminal pro-brain natriuretic peptide; IL, interleukin; VO2, aerobic exercise capacity; HFpEF, heart failure with preserved ejection fraction; VE/VCO2, ventilation efficiency/carbon dioxide ratio.