drugset / Trial / NCT04206865

Comparison of ARNI to Alternate Oral Vasodilator Therapies in Patients With Low Cardiac Output

NCT04206865

Phase 4 Withdrawn The Cleveland Clinic
RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2019-11-25
Primary completion
2020-09-10
Completion
2020-09-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hydralazine Small molecule Oral
Comparator Isosorbide Dinitrate Other / unclassified Oral
Subject Sacubitril-Valsartan Unknown Oral

Indications