NCT03307707

Brief Summary

the objective of this study is to :

  • Determinate wether the circulating levels of iFGF23 and klotho can be a predictor biomarker of HF in patients with CKD-MBD.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

Shorter than P25 for all trials

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

June 15, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 12, 2017

Completed
Last Updated

October 12, 2017

Status Verified

October 1, 2017

Enrollment Period

4 months

First QC Date

October 4, 2017

Last Update Submit

October 5, 2017

Conditions

Kidney Disease, ChronicHeart Failure

Keywords

FGF23klothoMineral Bone Disorder

Outcome Measures

Primary Outcomes (2)

  • Fibroblast Growth Factor 23 (FGF23)

    compare the circulating levels of FGF23 (pg/ml) in the two groups .

    completed data base (after 4 months)

  • Alpha Klotho

    compare the circulating levels of klotho (ng/ml) in the two groups .

    completed data base (after 4 months)

Study Arms (2)

Heart Failure (HF)

subjects with a Left Ventricular Ejection Fraction (LVEF) \<50% or LVEF \>50% and E/e'\>10.

No Heart Failure (NHF)

subjects with LVEF\>50%

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

subjects who visited the emmergency departement or the nephrology departement , meeting the criteria inclusion and have given a written consent .

You may qualify if:

  • Early CKD stage
  • Heart failure

You may not qualify if:

  • Infections
  • cancer
  • corticoid therapy
  • renal replacement therapy
  • Advanced CKD stage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples were centrifuged, the plasma were collected and stored at -80°C until utilization.

MeSH Terms

Conditions

Renal Insufficiency, ChronicHeart Failure

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Study Officials

  • Lamti Feten, PhD student

    Research Laboratory (LR12SP18) University of Monastir Tunisia, Tunisia and Research Unit (UR17ES29) Faculty of Pharmacy , Monastir

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 4, 2017

First Posted

October 12, 2017

Study Start

June 15, 2015

Primary Completion

September 30, 2015

Study Completion

December 30, 2015

Last Updated

October 12, 2017

Record last verified: 2017-10