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NCT03489993 · ClinicalTrials.gov registry record
FGF23 and Angiotensin-(1-7) in Hypophosphatemia (GAP)
A clinical trial, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- 8
- Enrollment target
NCT03489993: Completed study, sponsored by Wake Forest University Health Sciences.
NCT03489993 is a clinical trial that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 8 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03489993 has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- 8 participants
- Enrollment target
Study Summary
Hereditary hypophosphatemia encompasses rare genetic conditions characterized by renal phosphate wasting. Increased circulating levels of fibroblast growth factor 23 (FGF23), a key regulator of phosphorus metabolism, are critical to the pathophysiology of these diseases, most notably in X-linked hypophosphatemia (XLH). Increased FGF23 induces hypertrophy and scarring in the heart in part via stimulating the traditional renin-angiotensin system (RAS) pathway, angiotensin-converting enzyme (ACE)/angiotensin (Ang ll), particularly in patients with chronic kidney disease, but the effect of FGF23 on the heart in patients with FGF23-related hypophosphatemic diseases is unknown. In addition, the relationship between FGF23 and the angiotensin-converting enzyme 2 (ACE2)/angiotensin-(1-7) (Ang-(1-7) pathway of the RAS is unknown. The objective of this study is to describe the relationship between FGF23, which causes low phosphorus levels, and components of the RAS in the blood and urine to help the investigators understand why the disease occurs and how to better treat it. Subjects will be identified by querying the Electronic Medical Record according to medical diagnosis. Thirty subjects, 2-24 years of age, will be recruited from the tertiary care Pediatric Endocrinology and Pediatric Nephrology clinics at Brenner Children's Hospital. Inclusion criteria include a confirmed diagnosis of hereditary FGF23-related hypophosphatemia. Clinical data will be obtained from the Electronic Medical Record. Each subject will undergo study assessments at baseline, 6 months and 1 year that include blood work, an echocardiogram, and blood pressure measurements. The primary hypothesis is that subjects with higher Ang-(1-7) levels have lower rates of cardiac hypertrophy and thus are protected against high FGF23 levels. The secondary hypothesis is that subjects with higher Ang-(1-7) levels have lower systolic blood pressure.
Primary Outcome
Higher Ang-(1-7) levels will be associated with a decreased rate of left ventricular hypertrophy
Interventions
- DIAGNOSTIC_TEST Ang II and Ang-(1-7)
- DIAGNOSTIC_TEST FGF23 and klotho
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2018-12-06 |
| Est. Completion | 2020-12-23 |
What the finished NCT03489993 record still lists
NCT03489993 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 8 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Ang II and Ang-(1-7) is the first listed.
NCT03489993 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03489993 about?
NCT03489993 is a clinical study titled "FGF23 and Angiotensin-(1-7) in Hypophosphatemia (GAP)". Hereditary hypophosphatemia encompasses rare genetic conditions characterized by renal phosphate wasting. Increased circulating levels of fibroblast growth factor 23 (FGF23), a key regulator of phosphorus metabolism, are critical to the pathophysiology of these diseases, most notably in X-linked hyp...
What is the current status of trial NCT03489993?
This trial is currently completed. The enrollment target is 8 participants. The study started on 2018-12-06. Estimated completion is 2020-12-23.
What interventions are being tested in trial NCT03489993?
The interventions under investigation include: Ang II and Ang-(1-7) (DIAGNOSTIC_TEST), FGF23 and klotho (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03489993?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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