Dapagliflozin And Pulmonary Artery Hemodynamics in Heart Failure With Reduced Ejection Fraction Patients With CardioMEMS®
Part of paid clinical trials in La Jolla, California.
- Sponsor
- Scripps Health
- Study ID
- NCT04570865
- Phase
- PHASE4
- Status
- Unknown
Conditions
- Heart Failure, Systolic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- Dapagliflozin — DRUGThe 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.
- CardioMEMS — DEVICEThe 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.
Study Details
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.
Key Dates
- Start date
- Dec 1, 2020
- Status verified
- Sep 2020
- Primary completion
- Dec 1, 2021
- Completion
- Feb 1, 2022
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: DapagliglozinThe 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.
Primary Outcome Measure
Effect of Dapagliflozin on pulmonary diastolic pressure from baseline to 12 weeks of therapy Secondary End Points [ Time Frame: 12 weeka ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Scripps Clinic | La Jolla | California | 92037 | Melody Hermel, MD (SUB_INVESTIGATOR) Samantha Bagsic, PhD (SUB_INVESTIGATOR) Ruth Kuo, PharmD (SUB_INVESTIGATOR) |
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