Status:
WITHDRAWN
Digoxin for Congenital Erythrocytosis Due to Up-Regulated Hypoxia Sensing
Lead Sponsor:
University of Illinois at Chicago
Conditions:
Polycythemia; Familial
Erythrocytosis; Familial
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The investigators will study digoxin to inhibit the hypoxic response in congenital erythrocytosis due to germ line mutations that result in up-regulated hypoxia sensing. These forms of congenital eryt...
Detailed Description
The study will investigate digoxin to inhibit the hypoxic response in congenital erythrocytosis due to germ line mutations that result in up-regulated hypoxia sensing. These forms of congenital erythr...
Eligibility Criteria
Inclusion
- Inclusion criteria. To be eligible to participate, an individual must meet all of the following criteria:
- Have mutation of VHL (von Hippel Lindau), EGLN1 (encoding prolyl hydroxylase 2 \[PHD2\]) or EPAS1 (encoding HIF-2α) that has been associated with congenital erythrocytosis with upregulated hypoxia sensing.
- Have an up-regulated hypoxic response defined by a hemoglobin concentration of greater than 15.5 g/dL in women and 17.5 g/dL in men in association with a serum EPO concentration that is increased above the reference range or that is in the reference range but above the expected level given the presence of erythrocytosis, i.e. above the lower quartile of the range.
- Male or female, aged 18 years and older.
- For females of reproductive potential: use of highly effective contraception for 1 month prior to screening and agreement to use such a method during study participation and for an additional two weeks after the end of digoxin administration.
- Exclusion criteria. An individual who meets any of the following criteria will be excluded from participation:
- Diagnosis of polycythemia vera or high oxygen affinity hemoglobinopathy.
- End stage renal disease: estimated GFR \<15 mL/min/1.73 m2 or receiving hemodialysis or peritoneal dialysis.
- Electrolyte imbalance: potassium \<3.5 mEq/L, magnesium \<1.8 mg/dL, or calcium \>10.7 mg/dL.
- Hyperthyroidism (TSH \<0.3 U/ml and T4 \>12 μg/dL) or hypothyroidism (TSH \> 6 U/ml).
- Myocarditis.
- History of hypersensitivity, arrhythmia or severe gastrointestinal side effects related to digoxin.
- Presence or history of any of the following conditions: first or second-degree AV block, Wolff-Parkinson-White Syndrome, other cardiac conduction abnormalities, or heart failure with preserved left ventricular systolic function including restrictive cardiomyopathy, constrictive pericarditis, amyloid heart disease, acute cor pulmonale and idiopathic hypertrophic subaortic stenosis.
- Peripheral arterial disease or ischemic heart disease
- Pregnancy
Exclusion
Key Trial Info
Start Date :
November 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03433833
Start Date
November 10 2019
End Date
December 31 2024
Last Update
September 20 2024
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