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

NCT04570865 | Unknown Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: DAPA-MEMS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure, Systolic

Outcome Measures

Primary Outcomes (2)

• Effect of Dapagliflozin on pulmonary diastolic pressure from baseline to 12 weeks of therapy Secondary End Points

  PA diastolic pressure change

  12 weeka

• Compare the change in PA pressures, systolic and mean, from baseline to 12 weeks.

  PA pressure changes

  12 weeks

Secondary Outcomes (1)

• Describe the change in NT-ProBNP from baseline to 12 weeks

  12 weeks

Other Outcomes (5)

• Compare total diuretic dose from baseline to 12 weeks.

  12 weeks

• Determine the change in 6 min walk distance from baseline to 12 weeks

  12 weeks

• Compare the change in KCCQ from baseline to 12 weeks.

  12 weeks

Study Arms (1)

Dapagliglozin

EXPERIMENTAL

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.

Drug: Dapagliflozin; Device: CardioMEMS

Interventions

Dapagliflozin DRUG

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.

Dapagliglozin

CardioMEMS DEVICE

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.

Dapagliglozin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of HFrEF and existing CardioMEMs in place
• Patients who have historically been compliant with CardioMEMS followup
• Ejection fraction \< or = to 40%
• New York Heart Association (NYHA) class II-IV heart failure

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Scripps Health: lead

Study Sites (1)

Scripps Clinic

La Jolla, California, 92037, United States

Location

Related Publications (1)

• 1. Neal B, Perkovic V, Mahaffey KW, et al. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. N Engl J Med. 2017;377(7):644-657. doi:10.1056/NEJMoa1611925 2. Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015;373(22):2117-2128. doi:10.1056/NEJMoa1504720 3. Wiviott SD, Raz I, Bonaca MP, et al. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2019;380(4):347-357. doi:10.1056/NEJMoa1812389 4. McMurray JJV, Solomon SD, Inzucchi SE, et al. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019;381(21):1995-2008. doi:10.1056/NEJMoa1911303 5. Abraham WT, Adamson PB, Bourge RC, et al. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: A randomised controlled trial. Lancet. 2011;377(9766):658-666. doi:10.1016/S0140-6736(11)60101-3

  RESULT

MeSH Terms

Conditions

Heart Failure, Systolic

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Advanced Heart Failure Program

Model 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.

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: September 30, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: February 1, 2022
• Last Updated: September 30, 2020

Record last verified: 2020-09

Locations

US (1)