Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04956809 | Effect of Dapagliflozin on Submaximal Exercise Tolerance in Heart Failure | PHASE2 | COMPLETED | 3 | — | — | Oct 22, 2021 | Jun 1, 2023 | Dec 12, 2023 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Dapagliflozin 10mg | ACTIVE_COMPARATOR | Active arm will be 6 weeks in duration, separated by a 2-week wash-out period. |
| Placebo | PLACEBO_COMPARATOR | Placebo arm will be 6 weeks in duration, separated by a 2-week wash-out period. |
| Name | Type | Description |
|---|---|---|
| Dapagliflozin 10Mg Tab | DRUG | This will be a single-center randomized, placebo controlled, double-blind, 2-treatment, 2-phase cross-over trial in 27 HFrEF subjects: (A) Dapa 10 mg daily; (B) Placebo. |
| Placebo | DRUG | This will be a single-center randomized, placebo controlled, double-blind, 2-treatment, 2-phase cross-over trial in 27 HFrEF subjects: (A) Dapa 10 mg daily; (B) Placebo. |
Inclusion Criteria: 1. Diagnosis of HFrEF with NYHA Class II-III functional class, which has been present for at least two months 2. Left ventricular ejection fraction ≤ 40% 3. Stable medical therapy for at least 1 month 4. Plasma NT-proBNP level of: ≥ 200pg/mL; OR ≥ 125pg/mL if they were hospitali...