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.
Peter Eckman, MD
Sensible Medical Innovations Ltd.