Study for Promotion of Health in Recycling Lead (SPHERL)

• ClinicalTrials.gov Identifier: NCT02243904
• Recruitment Status: Active, not recruiting
• First Posted: September 18, 2014
• Last Update Posted: March 3, 2020
• Sponsor: KU Leuven
• Information provided by (Responsible Party): Jan A. Staessen, KU Leuven

Tracking Information

• First Submitted Date: September 10, 2014
• First Posted Date: September 18, 2014
• Last Update Posted Date: March 3, 2020
• Study Start Date: August 2015
• Estimated Primary Completion Date: July 1, 2024 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 16, 2014): Annual change in systolic blood pressure as measured by 24-h ambulatory monitoring [ Time Frame: Baseline, 1 year and 2 years ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 16, 2014)

• Annual change in central hemodynamics [ Time Frame: Baseline, 1 year and 2 years ]
  Annual changes in the central hemodynamics, including aortic blood pressure, the central systolic augmentation index, and aortic pulse wave velocity
• Annual change in heart function [ Time Frame: Baseline, 1 year and 2 years ]
  Annual changes in ECG-derived indexes
• Annual change in renal function [ Time Frame: Baseline, 1 year and 2 years ]
  Annual changes in glomerular and tubular renal function measured on a continuous scale and the incidence of renal dysfunction
• Annual change in autonomic nervous function [ Time Frame: Baseline, 1 year and 2 years ]
  Annual changes in alterations in the autonomic nervous cardiovascular modulation, as assessed by heart rate variability
• Annual change in peripheral nervous conduction velocity [ Time Frame: Baseline, 1 year and 2 years ]
  Annual changes in nerve conduction velocity
• Annual change in neurocognitive performance [ Time Frame: Baseline, 1 year and 2 years ]
  Annual changes in neurocognitive testing
• Annual change in quality of life [ Time Frame: Baseline, 1 year and 2 years ]
  Annual changes in self-assessed quality of life

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study for Promotion of Health in Recycling Lead
• Official Title: Study for Promotion of Health in Recycling Lead

Brief Summary

Study for Promotion of Health in Recycling Lead (SPHERL) is a prospective 2-year follow-up study of lead workers with exposure levels varying between and within individuals. SPHERL addresses to what extent between-subject differences or within-subject changes in lead exposure may have a measurable impact on blood pressure, the cardiovascular system, renal function, the autonomic nervous system, peripheral nervous conduction velocity, and neurocognitive function.

At the beginning of December 2015, 70 participants were included in the study.

Detailed Description

Background

• Whether low-level lead exposure impacts on blood pressure, regulation of the cardiovascular system, glomerular or tubular renal function, sympathetic nervous modulation, peripheral nervous conduction velocity, and neurocognitive function remains uncertain.

Study Population

• SPHERL will enroll 500 lead recycling workers with changing lead exposure, who will be examined at baseline (2014-2015) and followed up at annual intervals for 2 years (2016-2017).

Methods

• Volunteers eligible for the study are (i) new and existing hires without previous occupational lead exposure who will be performing tasks with or without occupational lead exposure and (ii) existing hires with occupational lead exposure who will be transitioning to job tasks without occupational lead exposure within the next 2 years.
• Blood lead concentration will be the main biomarker of exposure.
• The main outcome variables are (i) blood pressure measured conventionally and by ambulatory monitoring, and analyzed as continuous or categorical variable, both cross-sectionally and longitudinally; (ii) indexes of glomerular and tubular renal function, (iii) heart rate variability analyzed in the frequency domain as measure of autonomous sympathetic modulation, (iv) peripheral nerve conductivity, (v) neurocognitive performance, (vi) and quality of life [the EuroQOL five dimensions (EQ-5D) questionnaire].

Expected Outcomes

• Assuming a 4-fold or higher surge in the blood lead concentration, the study is powered to demonstrate over 2 years an acceleration in the age-related rise of systolic blood pressure by 1 to 4 mm Hg or an increase of the coefficient of multiple determination (R2) from 0.22 to 0.24 by adding the change in the blood lead concentration to models relating changes in blood pressure to three other covariables. The longitudinal design of our study complies with the temporality principle of the Bradford-Hill criteria for assessing possible causality between outcomes and exposure.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Participants will be recruited among the work force employed at lead recycling plants in North America.
• Condition: Occupational Exposure
• Intervention: Not Provided
• Study Groups/Cohorts: Lead exposure

Publications *

• Hara A, Gu YM, Petit T, Liu YP, Jacobs L, Zhang ZY, Yang WY, Jin Y, Thijs L, Wei FF, Nawrot TS, Staessen JA. Study for Promotion of Health in Recycling Lead - Rationale and design. Blood Press. 2015 Jun;24(3):147-57. doi: 10.3109/08037051.2014.996409. Epub 2015 Jan 26.
• Yu YL, Thijs L, Saenen N, Melgarejo JD, Wei DM, Yang WY, Yu CG, Roels HA, Nawrot TS, Maestre GE, Staessen JA, Zhang ZY. Two-year neurocognitive responses to first occupational lead exposure. Scand J Work Environ Health. 2021 Apr 1;47(3):233-243. doi: 10.5271/sjweh.3940. Epub 2020 Dec 4.
• Yu YL, Yang WY, Thijs L, Melgarejo JD, Yu CG, Wei DM, Wei FF, Nawrot TS, Zhang ZY, Staessen JA. Two-Year Responses of Office and Ambulatory Blood Pressure to First Occupational Lead Exposure. Hypertension. 2020 Oct;76(4):1299-1307. doi: 10.1161/HYPERTENSIONAHA.120.15590. Epub 2020 Sep 9.
• Yu CG, Wei FF, Yang WY, Zhang ZY, Mujaj B, Thijs L, Feng YM, Staessen JA. Heart rate variability and peripheral nerve conduction velocity in relation to blood lead in newly hired lead workers. Occup Environ Med. 2019 Jun;76(6):382-388. doi: 10.1136/oemed-2018-105379. Epub 2019 Mar 30.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: March 1, 2020): 270
• Original Estimated Enrollment (submitted: September 16, 2014): 500
• Estimated Study Completion Date: December 31, 2024
• Estimated Primary Completion Date: July 1, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Women and men are eligible.
• New hires without previous occupational lead exposure who will be performing tasks with lead exposure or current employees without previous occupational lead exposure moving to tasks with exposure.
• Informed written consent.

Exclusion Criteria:

• Pregnancy.
• Any serious health condition.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT02243904
• Other Study ID Numbers: SPHERL
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Jan A. Staessen, KU Leuven
• Original Responsible Party: Same as current
• Current Study Sponsor: KU Leuven
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jan A Staessen, MD, PhD; University of Leuven

• PRS Account: KU Leuven
• Verification Date: March 2020