Status:
COMPLETED
SGLT2 Inhibitors in Transthyretin Amyloid Cardiomyopathy
Lead Sponsor:
Columbia University
Conditions:
Transthyretin Amyloid Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a single center, single arm, prospective, 12 week open label pilot trial of the sodium-glucose cotransporter 2 inhibitor (SGLT2i), empagliflozin 10 mg oral daily, in patients with transthyreti...
Detailed Description
Transthyretin amyloid cardiomyopathy (ATTR-CM) is an underrecognized cause of heart failure among older adults, in which misfolded transthyretin (TTR) proteins build up in the muscle tissue of the hea...
Eligibility Criteria
Inclusion
- Every participant must meet all of the following inclusion criteria to be eligible for enrollment in this study:
- Age ≥ 18 years old
- Diagnosis of TTR cardiac amyloidosis (wild type or variant), confirmed by the presence of amyloid deposits on analysis of biopsy specimens obtained from cardiac and noncardiac sites (e.g. fat aspirate, gastrointestinal sites, salivary glands, or bone marrow), technetium-99m pyrophosphate cardiac scintigraphy, or mass spectrometry
- Normal serum free light chain ratio and the absence of abnormal monoclonal band on serum and urine immunofixation
- Subjects will have at least 1 of the indications below for an SGLT2i, and meet package-insert criteria for drug initiation: non-insulin dependent diabetes mellitus 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 m2 of body-surface area)
- On stable oral diuretics (defined as no more than a 50% increase from baseline diuretic dose established during a sustained 2 week period) within 2 weeks before enrollment
- Able to understand and sign the informed consent document after the nature of the study has been fully explained
Exclusion
- The presence of any of the following excludes eligibility for enrollment in this study:
- Prior liver or heart transplantation
- Active malignancy or non-amyloid disease with expected survival of less than 1 year
- Heart failure, in the opinion of the investigator, primarily caused by severe left-sided valve disease. Note: if valve was repaired, subject may be considered as no longer with severe valve disease
- Heart failure, in the opinion of the investigator, primarily caused by ischemic heart disease
- Ventricular assist device or anticipated within the next 6 months
- Pacemaker or implantable cardioverter defibrillator incompatible with magnetic resonance technology
- Absolute contraindication for quantitative magnetic resonance (e.g. aneurysmal clips, metal objects)
- Impairment from stroke, injury or other medical disorder that precludes participation in the study
- Myocardial infarction, cardiovascular surgery, stroke or transient ischemic attack 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) \<15 mL/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 if concomitant 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 this study
Key Trial Info
Start Date :
March 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05233163
Start Date
March 14 2022
End Date
May 1 2023
Last Update
August 6 2024
Active Locations (1)
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1
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York, New York, United States, 10032