Phase
Condition
Amyloidosis
Circulation Disorders
Treatment
Empagliflozin
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Every participant must meet all of the following inclusion criteria to be eligiblefor enrollment in this study:
Age ≥ 18 years old
Diagnosis of TTR cardiac amyloidosis (wild type or variant), confirmed by thepresence of amyloid deposits on analysis of biopsy specimens obtained fromcardiac and noncardiac sites (e.g. fat aspirate, gastrointestinal sites,salivary glands, or bone marrow), technetium-99m pyrophosphate cardiacscintigraphy, or mass spectrometry
Normal serum free light chain ratio and the absence of abnormal monoclonal bandon serum and urine immunofixation
Subjects will have at least 1 of the indications below for an SGLT2i, and meetpackage-insert criteria for drug initiation: non-insulin dependent diabetesmellitus with hemoglobin A1c ranging from 6.5-9.9 OR chronic kidney disease (defined as an estimated glomerular filtration rate of 25-75 ml/minute/1.73 m2of body-surface area)
On stable oral diuretics (defined as no more than a 50% increase from baselinediuretic dose established during a sustained 2 week period) within 2 weeksbefore enrollment
Able to understand and sign the informed consent document after the nature ofthe study has been fully explained
Exclusion
Exclusion Criteria:
- The presence of any of the following excludes eligibility for enrollment in thisstudy:
Prior liver or heart transplantation
Active malignancy or non-amyloid disease with expected survival of less than 1year
Heart failure, in the opinion of the investigator, primarily caused by severeleft-sided valve disease. Note: if valve was repaired, subject may beconsidered as no longer with severe valve disease
Heart failure, in the opinion of the investigator, primarily caused by ischemicheart disease
Ventricular assist device or anticipated within the next 6 months
Pacemaker or implantable cardioverter defibrillator incompatible with magneticresonance technology
Absolute contraindication for quantitative magnetic resonance (e.g. aneurysmalclips, metal objects)
Impairment from stroke, injury or other medical disorder that precludesparticipation in the study
Myocardial infarction, cardiovascular surgery, stroke or transient ischemicattack within the prior 90 days
Disabling dementia or other mental or behavioral disease
Enrollment in a clinical trial not approved for co-enrollment
Expected use of continuous intravenous inotropic therapy in the next 6 months
High risk for non-adherence as determined by screening evaluation
Inability or unwillingness to comply with the study requirements
Chronic kidney disease with estimated glomerular filtration rate (eGFR) <15mL/min/1.73 m2 or end-stage renal disease
Current or prior SGLT2i use
Type 1 diabetes mellitus or insulin-dependent diabetes mellitus
N-terminal (NT)-pro hormone BNP (NT-proBNP) < 300 pg/mL or < 900 pg/mL ifconcomitant diagnosis of atrial fibrillation
History of ketoacidosis
History of complex urinary tract or genital infections
History of kidney stone
Systolic blood pressure < 90 mmHg and symptomatic hypotension
Systolic blood pressure ≥ 180 mmg Hg
Chronic obstructive pulmonary disease
Major surgery in the 90 days before or after screening
Chronic alcohol or drug abuse
Nursing home resident
Other reason that would make the subject inappropriate for entry into thisstudy
Study Design
Study Description
Connect with a study center
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York, New York 10032
United StatesSite Not Available
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