Clinical Trials Logo

Clinical Trial Summary

Fibroblast growth factor 23 (FGF23) is a key hormone of the mineral metabolism produced in bone and acting on the kidney to lower phosphatemia. FGF23 is subject to inactivating proteolytic cleavage which results in the presence of C-terminal and N-terminal fragments heretofore described as inactive. We recently showed an increase in FGF23Ct in sickle cell patients, its association with left ventricular mass as well as a direct, pro-hypertrophic effect of FGF23Ct on rat cardiomyocytes. Data from the literature suggest that hypoxia (linked or not to anemia) is responsible for an increase in the production and cleavage of FGF23, either via the hypoxia inducible factor (HIF1α) or via the increase in erythropoietin (EPO). We hypothesize that the FGF23Ct / FGF23i ratio is increased in response to chronic tissue hypoxia, in the absence of anemia, in patients with chronic respiratory failure (CRF) either due to a direct response to hypoxia via the stimulation of HIF1α, or indirectly via the increase in the circulating concentration of EPO. This elevation, if proven, could contribute to the increased risk of heart disease seen in some populations of CRF. We propose to test this hypothesis by assaying FGF23Ct and FGF23i in a cohort of adult CRF patients before and after initiation of oxygen therapy. The object of the present study is to study the FGF23Ct / FGF23i ratio in incident patients presenting with a non treated CRF as well as the modifications of this ratio under oxygen therapy and to study the correlations between FGF23 Ct and FGF23 and i) oxygen saturation and PaO2 ii) echocardiographic parameters and iii) EPO concentrations. Three visits are planned: Baseline (before initiation of oxygen therapy), and two visits after initiation of oxygen therapy, at 3 months (M3) and at 12 months (M12). For each visit, anthropometric and clinical data, treatment and biological results will be collected. FGF23 intact , FGF23 C-terminal and Erythropoietin will be measured. A cardiac ultrasound will be performed at baseline and at M12.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05258370
Study type Observational
Source Assistance Publique - Hôpitaux de Paris
Contact Natacha Nohilé
Phone 331 56 09 59 82
Email natacha.nohile@aphp.fr
Status Not yet recruiting
Phase
Start date June 2023
Completion date May 2026

See also
  Status Clinical Trial Phase
Completed NCT05084976 - Parental Perception of COVID-19 Vaccine in Technology Dependent Patients
Not yet recruiting NCT05756387 - Improving Chronic Nocturnal Noninvasive Ventilation: a Multimodality Approach
Enrolling by invitation NCT04208581 - Yiqi Huoxue Huatan Granule for Reducing Mortality in COPD With Chronic Respiratory Failure Phase 3
Recruiting NCT02260583 - Effect of Extracorporeal CO2 Removal in Stable Hypercapnic COPD Patients N/A
Completed NCT01255111 - Adaptation to Nocturnal Noninvasive Ventilation in Patients With Chronic Respiratory Failure (ROOMILA) N/A
Active, not recruiting NCT03499470 - Structured Discharge and Follow-up Protocol for COPD Patients Receiving LTOT and NIV N/A
Completed NCT04143230 - Identification of In-hospital Patients in Need of Palliative Care Using a New Simplified Screening Tool N/A
Terminated NCT00208078 - Effect of Non-Invasive Ventilation in Cystic Fibrosis Patient With Chronic Respiratory Failure. Phase 4
Recruiting NCT06286917 - Initiation of Noninvasive Ventilation in ALS Patients With Chronic Respiratory Insufficiency N/A
Completed NCT02342899 - Cost Effectiveness of Outpatient Set-up of Automated NIV in Obese Patients With Chronic Respiratory Failure Phase 3
Terminated NCT03473171 - Implementation of Nasal Non-Invasive Ventilation With a RAM Cannula in the Inpatient /Outpatient Setting N/A
Completed NCT02804243 - The Efficacy of Nasal High Flow Oxygen Therapy With Rehabilitation in the Patients With Chronic Respiratory Failure N/A
Completed NCT01479959 - Impact of Patient Controlled Positive End-expiratory Pressure on Speech in Tracheostomized Ventilated Patients N/A
Completed NCT01090986 - Home Mechanical Ventilation Effectiveness and Air Leaks N/A
Completed NCT00698958 - Ambulatory Adaptation to Non-Invasive Mechanical Ventilation Phase 4
Not yet recruiting NCT06119087 - Mechanical Insufflation in the Philadelphia Amyotrophic Lateral Sclerosis Cohort (MI-PALS) Study N/A
Recruiting NCT05796297 - Clinical Impact of Patient-ventilator Asynchrony
Recruiting NCT04481295 - Study on Optimal Oxygen Concentration During Pulmonary Rehabilitation N/A
Withdrawn NCT05379439 - Family Connections N/A
Terminated NCT03809832 - Microbiologic Contamination of Home Non Invasive Ventilators