Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT03433833
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03433833
Study Brief:
Protocol Section:
NCT03433833