Prognostic Value of Functional Exercise Test (EFX) in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— EFX  

Official title:

Prognostic Value of Functional Exercise Test (EFX) in Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02994017
• Other study ID #: 2011_31
• Secondary ID: 2011-A01532-39
• Status: Completed
• Phase: N/A
• Start date: March 5, 2012
• Est. completion date: June 16, 2019

Study information

• Verified date: February 2023
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of study is to prospectively determine if CPET with blood gas analysis should have a prognostic value in CF. The study plans to include 300 cystic fibrosis patients. Inclusion criteria will be: age >15 years, cystic fibrosis confirmed by chloride sweat test or genetic analysis, clinical and functional stability in the 2 month before CPET. Patients will perform a maximal exercise test on a cycloergometer during the inclusion visit, with pulmonary function testing and a six-minute walk test. The study will also include a visit every 6 months with: body mass index calculation, pulmonary function testing with DLCO (diffusing lung capacity for carbon monoxide), a six minute walk test, and antibacteriological study of sputum. The results of this study could help identify earlier the patients for referral to a lung transplantation centre, by using the usual criteria and the CPET abnormalities.

Description:

Current guidelines for referring cystic fibrosis (CF) patients for lung transplantation, based on clinical and functional resting parameters, are insufficient to predict 3-year mortality. Previous studies have shown that sex, impaired pulmonary function, undernutrition and colonization of the respiratory tract by Pseudomonas aeruginosa are associated with a poor prognosis. Current guidelines for referral to a lung transplant center include age, sex, forced expiratory volume at one second (FEV1) below 30% predicted or a rapid decline of FEV1, in particular in young female patients, increasing frequency of exacerbations requiring antibiotic therapy, refractory or recurrent pneumothorax, recurrent hemoptysis not controlled by embolization. But, despite these criteria, near that 30% of patients are still dying while on the lung transplant waiting list, or are transplanted in high emergency. Cardiopulmonary exercise testing (CPET) in CF patients would have an interest in the following of cystic fibrosis patients. A previous study, carried out on fifty one adult patients, showed that CPET with blood gas analysis may have a prognosis value in cystic fibrosis. The authors found that a BMI < 19.8 and P(A-a)O2 peak > 43 mmHg were independently associated with a lower chance of survival.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: June 16, 2019
• Est. primary completion date: June 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Age more than 15 years
• Cystic fibrosis diagnosed by positive sweat chloride test or genetic test

Exclusion Criteria:

• Pregnant or breastfeeding woman
• waiting on transplantation list

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• cardiopulmonary exercise testing
The Cardiopulmonary exercise testing (CPET) was performed at the beginning of the study, the same at each center. Each patient underwent a symptom-limited incremental exercise test on an ergometric bicycle (Ergoline-Ergometrics 800®). The protocol included a warm-up period of 3 min at 20 W followed by a progressively increasing work rate (WR) in a ramp fashion and then 3 min recovery. The ramped WR increment was individualized (range,8-30 W/min). during exercise, heart rate (HR) was monitored continuously by 12-lead ECG, and arterial oxygen saturation (SpO2) was measured by pulse oximetry (Nellcor N-395). The expired gases were analyzed with an Ergocard®, focusing on oxygen consumption(VO2), carbon dioxide production (VCO2), minute ventilation (VE), and tidal volume (VT).

Locations

Country	Name	City	State
France	Hôpital Calmette, CHRU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	the survival is defined by the occurrence of death or lung transplantation.	at five years
Secondary	6 minute walking distance		Every 12 months during 5 years
Secondary	body mass index calculation		Every 12 months during 5 years
Secondary	sputum sample culture	(a descriptive analysis of Haemophilus influenzae, Staphylococcus aureus, Pseudomonas aeruginosa,Burkholderia cepacia streptococci in the bacterial flora of sputum)	Every 12 months during 5 years
Secondary	pulmonary function testing with DLCO	diffusing lung capacity for carbon monoxide.	Every 12 months during 5 years