NCT02994017

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
287

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2012

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 15, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2019

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

7.3 years

First QC Date

August 16, 2016

Last Update Submit

February 3, 2023

Conditions

Cystic Fibrosis

Keywords

cystic fibrosisCardiopulmonary exercise testingprognostic

Outcome Measures

Primary Outcomes (1)

  • Survival

    the survival is defined by the occurrence of death or lung transplantation.

    at five years

Secondary Outcomes (4)

  • 6 minute walking distance

    Every 12 months during 5 years

  • body mass index calculation

    Every 12 months during 5 years

  • sputum sample culture

    Every 12 months during 5 years

  • pulmonary function testing with DLCO

    Every 12 months during 5 years

Study Arms (1)

cystic fibrosis patients

OTHER
Other: cardiopulmonary exercise testing

Interventions

cardiopulmonary exercise testingOTHER

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).

cystic fibrosis patients

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnant or breastfeeding woman
  • waiting on transplantation list

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Calmette, CHRU

Lille, France

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Anne Prevotat, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2016

First Posted

December 15, 2016

Study Start

March 5, 2012

Primary Completion

June 16, 2019

Study Completion

June 16, 2019

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)