NCT04570865

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Scripps Health · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Prior studies have demonstrated an association between the use of sodium-glucose cotransporter 2 (SGLT-2) inhibitors for diabetic patients and reductions in composite primary outcomes of cardiovascular mortality, nonfatal myocardial infarction, or nonfatal stroke, as well as reductions in heart failure among patients with diabetes. The 2019 DAPA-HF trial studied whether the addition of the SCLT-2 inhibitor dapagliglozin could benefit patients with heart failure with reduced ejection fraction (HFrEF), either with or without diabetes. Results indicated that that SGLT-2 inhibitors resulted in 4.9% absolute reduction in the cardiovascular death or worsening heart failure and a 2.3% absolute reduction in all-cause mortality in patients with and without diabetes. Dapagliflozin is FDA approved to reduce the risk of cardiovascular death or hospitalization in patients with HFrEF with or without Type 2 diabtes. The mechanisms of cardiovascular benefit remain unclear, however it is likely to be driven by a reduction in heart failure death given that rates of myocardial infarction were similar between treatment arms. The CardioMEMS® system is an implantable device that can measure pulmonary artery systolic, diastolic and mean pressure on a daily basis. It has been shown convincingly that monitoring the MEMS device results in reduced pulmonary pressures and in turn a reduction in heart failure hospitalizations. 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.

Conditions

• Heart Failure, Systolic

Interventions

Type	Name	Description
DRUG	Dapagliflozin	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.
DEVICE	CardioMEMS	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.

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-12-01
• Completion: 2022-02-01
• First posted: 2020-09-30
• Last updated: 2020-09-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study