Table 2.
Recent and ongoing studies in heart failure with preserved ejection fraction.
| Study | Type | Drug/comp. | Number of pts/Age | Outcome | Results |
|---|---|---|---|---|---|
| TOP-CAT | Outcome | Spironolactone versus placebo | 3445/69 | Primary outcome: CV death/HF hospitalization/aborted cardiac arrest | In follow-up 3.3 years 18 versus 20 (p = 0.14) |
|
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| Aldo-DHF | PoC | Spironolactone versus placebo | 422/67 | Coprimary outcomes: (i) Diastolic dysfunction (E/E′) (ii) Exercise capacity/peak VO2 |
In 12-month follow-up (i) 12.1 versus 13.6 (p < 0.001) (ii) 16.8 versus 16.9 (p = NS) |
|
| |||||
| RELAX | PoC | Sildenafil versus placebo | 216/69 | Primary outcome: exercise capacity/peak VO2 Secondary outcome: (i) 6 min walk test (ii) Clinical outcome |
In 24-week follow-up (i) −0.2 versus −0.2 (p = NS) (ii) 5.0 versus 15 m (p = NS) (iii) 94 versus 95 (p = NS) |
|
| |||||
| PARAMOUNT | PoC | LCZ 696 angiotensin rec. + Neprilysin inhib. versus valsartan | 266/71 | Change NT-proBNP Side effects |
Ratio LCZ696/valsartan 0.77 (p = 0.005) 22 patients (15%) on LCZ696 versus 30 (20%) on valsartan |
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| DHART | PoC | Anakinra versus placebo | 12/62 | Exercise capacity/peak VO2 | +1.2 mL/kg/min (+8%, p = 0.009) |
|
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| RALI-DHF | PoC | Ranolazine (iv 24 h infusion followed by 13 days of oral treatment) versus placebo |
20/73 | Changes in hemodynamic parameters Changes in echocardiography, PeakVO2, and NT-proBNP parameters |
LVEDP (mmHg) 23 versus 19 (p = 0.04); PCWP 18 versus 12 (p = 0.04) No changes (p = NS) |
|
| |||||
| Kosmala | PoC | Ivabradine versus placebo | 61/67 | Exercise capacity (METS) Peak VO2 |
+1.5 versus +0.4 (p = 0.001) +3.0 versus +0.4 (p = 0.003) |
|
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| PARAGON-HF | Outcome | LCZ956 versus valsartan | CV death and HF Hospitalization | Ongoing | |
|
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| SOCRATES-PRESERVED | PoC | Vericiguat (guanylate cyclase stimulator) | Change in NT-proBNP | Ongoing | |
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| EDIFY | Outcome | Ivabradine versus placebo | 400 | Diastolic dysfunction (E/E′, exercise capacity, NT-proBNP) | Ongoing |
PoC, proof-of-concept.