Overview

Dapagliflozin And Pulmonary Artery Hemodynamics in Heart Failure With Reduced Ejection Fraction Patients With CardioMEMS®

Status:
Not yet recruiting
Trial end date:
2022-02-01
Target enrollment:
0
Participant gender:
All
Summary
The focus of this study is to investigate the use of Dapagliflozin in HFrEF (NYHA II-IV) patients with or without diabetes who have CardioMEMS® implanted to assess the impact on pulmonary artery pressure measurements after 12 weeks of therapy.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Scripps Health
Treatments:
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Dapagliflozin
Criteria
Inclusion Criteria

1. Diagnosis of HFrEF and existing CardioMEMs in place

2. Patients who have historically been compliant with CardioMEMS followup

3. Ejection fraction < or = to 40%

4. New York Heart Association (NYHA) class II-IV heart failure

5. Able to read and write in English Exclusion Criteria

1. creatinine clearance less than or equal to 45 2. History of renal transplant 3. systolic
blood pressure less than 85 on time of initiation of drug 4. intolerance/allergy to farxiga
5. pregnant patients or those who are planning to become pregnant during the study period
6. unable to read and write in English 7. acutely hospitalized patients or those who were
hospitalized in the past 30 days 8. history of noncompliance with CardioMEMS followup 9.
History of frequent mycotic urinary tract infections 10. History of organ transplantation