Patients with cardiac amyloidosis.
Conditions
Interventions
Trade Name: Forxiga
Product Name: Forxiga
Pharmaceutical Form: Film-coated tablet
Sponsors
Region Västerbotten
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: • Established diagnosis of ATTRv or ATTRwt amyloidosis verified by either: 1. Tissue biopsy with ATTR amyloid deposits OR 2. DPD scintigraphy with Perugini scale grade II or III cardiac uptake and absence of monoclonal bands in serum and urine electrophoresis and normal free light chain assay ruling out AL amyloidosis. • Clinical diagnosis of HF according to ESC criteria for diagnosing HF with symptoms of heart failure and a left ventricular ejection fraction of 12 mm • DPD scintigraphy uptake in the myocardium Perugini scale grade II or III • Optimal treated and stable HF and ATTR amyloidosis for at least four weeks, according to the treating physician. • Genetic testing is performed on all patients to determine diagnosis of ATTRwt or ATTRv • Age = 18 • TTE performed withing 12 months of screening visit. • Women of Childbearing Capacity (WOCBC) must comply to use of highly effective contraception methods during the trial. Acceptable methods according to CTFG guidelines are combined hormonal contraception (oral, dermal, intravaginal), progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), an intrauterine device, an intrauterine hormone-releasing system or by refraining from heterosexual intercourse during the entire period of risk. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Expected survival < 9 months 2. Estimated glomerular filtration rate <25 ml/ min 3. Karnofsky performance status <60% 4. Diabetes mellitus treated with insulin or sulfonylureas 5. Acute cardiac hospitalization or procedure within 4 weeks (HF hospitalization, myocardial infarction, pacemaker implantation, cardioversion, coronary angioplasty) 6. Participation in other clinical trial not approved for co-enrollment 7. Inability or unwillingness to comply with the study requirements 8. Current SGLT2-inhibitor use or previous discontinuation due to side effects 9. History of ketoacidosis 10. Systolic blood pressure <90 mmHg 11. Uncontrolled hypertension 12. Severe hepatic impairment, unstable or rapidly progressing hepatic disease at the time of randomization as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: Assess impact of dapagliflozin on NT-proBNP levels in patients with optimally treated cardiac ATTR amyloidosis ;Secondary Objective: The secondary objectives of this study are: • determine whether dapagliflozin reduces patient-reported HF symptoms in patients with optimally treated cardiac ATTR amyloidosis. • assess whether dapagliflozin improves walking distance at 6MWT in patients with cardiac ATTR amyloidosis ;Primary end point(s): The primary endpoint is change in level or slope of NTproBNP during the treatment period compared to the non-treatment periods.;Timepoint(s) of evaluation of this end point: At every study visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in Kansas City Cardiomyopathy Questionnaire total symptom score during the treatment period compared to the non-treatment period • Change in 6-minute walking distance during the treatment period compared to the non-treatment period • Safety endpoints: -Blood pressure -Diuretic intake -Any patient-reported side effect during treatment period with dapagliflozin . ;Timepoint(s) of evaluation of this end point: KCCQ - 3 times per period 6 MWT - 3 times per period | — |
Countries
Sweden
Contacts
Public ContactSponsor, Coordinating Investigator
Umeå University
Outcome results
None listed