SMILE™

STUDY IDENTIFIER:

SMILE™

CONDITION:

Heart Failure

CONTACT INFO:

Kelly Wilson   |   Kelly.Wilson@allina.com   |   612-863-6288

DESCRIPTION:

Multi center, randomized controlled study, to determine if a significant decrease in the rate of heart failure re-hospitalizations occurs during a follow-up period when investigational ReDS guided treatment is used as an adjunct to standard of care.

CRITERIA LIST/ QUALIFICATIONS:

  • Diagnosis of HF, with preserved or reduced LVEF, was made at least 30 days prior to enrollment.
  • Patients with LVEF <40% must have been treated at least 30 days prior to enrollment with diuretics and beta-blocker (unless intolerant or contra-indicated) and an ACE-inhibitor or ARB (unless intolerant or contra-indicated).
  • The index STEMI must meet the following criteria:
    • First time diagnosis of STEMI AND;
    • Meet the STEMI criteria of the American College of Cardiology (ACC)/American Heart Association (AHA) (e.g. ST elevation in at least 2 contiguous leads >0.2mV in V1, V2 or V3 and/or >0.1mV in at least two other leads), or new left bundle branch block (LBBB)
  • BMI >22 and <38; Height >5.1 and <6.4 feet
  • BNP ≥ 350 pg/ml within 24h of consenting and/or ≥ 750 pg/ml any time during the hospital stay or NT pro BNP ≥ 1400 pg/ml within 24h of consenting or NT-pro BNP ≥ 3000 pg/ml any time during the hospital stay.

INVESTIGATORS:

Peter Eckman, MD

SPONSORS:

Sensible Medical Innovations Ltd.

STATUS:

Open/Enrolling