Comparison of ARNI to Alternate Oral Vasodilator Therapies in Patients With Low Cardiac Output
Status:
Withdrawn
Trial end date:
2020-09-10
Target enrollment:
Participant gender:
Summary
This is a prospective, randomized, non-blinded, single-center efficacy study of acutely
decompensated heart failure patients with reduced ejection fraction (HFrEF), low cardiac
index (<2.2) as determined by pulmonary artery catheter (PAC) who have been hemodynamically
stabilized and ready for transition to oral vasodilator therapy at the discretion of the
clinician. The investigators would like to accomplish the following objectives with this
study:
1. Establish the superiority of an upfront initiation strategy for sacubitril-valsartan at
maintaining patients on ARNI therapy at one-month follow-up compared to usual care.
2. Establish the safety of initiating sacubitril-valsartan in an intensive care setting
3. Characterize the hemodynamic effect of sacubitril-valsartan on patients with low cardiac
output
4. Expand the population of hospitalized patients that can be initiated on ARNIs and thus
facilitate prior to hospital discharge patients who are on optimal goal-directed medical
therapy (GDMT) for heart failure
Phase:
Phase 4
Details
Lead Sponsor:
The Cleveland Clinic
Treatments:
Isosorbide Dinitrate LCZ 696 Sacubitril and valsartan sodium hydrate drug combination Valsartan Vasodilator Agents