What this phase means
Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Sacubitril / Valsartan, SGLT-2 inhibitor, or Sacubitril / Valsartan. The registry lists allocation as randomized. In patients with heart failure due to a reversible underlying cause-such as valvular heart disease or coronary artery disease-surgical or procedural correction of the underlying lesion (valve repair/replacement, TAVI, PCI, or CABG) frequently leads to spontaneous recovery of cardiac function, even without neurohormonal modulators.
They plan to enroll about 80 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
DELayed Initiation of ARNI and SGLT2i in Heart Failure With Corrected aetiologY (DELAY-HF), Pilot Study
Interventions: Sacubitril / Valsartan, SGLT-2 inhibitor, Sacubitril / Valsartan, SGLT2 Inhibition
Primary outcome (registry wording): Change in left ventricular ejection fraction (LVEF) at 12 months