World Trade Center (WTC) RENAL

Cardiovascular Disease Clinical Trial

Official title:

Renal and Cardiovascular Impairment in WTC Responders: Implications for Diagnosis and Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02246101
• Other study ID #: GCO 13-1847
• Secondary ID: 1U01OH010716-01
• Status: Completed
• Phase: N/A
• First received: September 16, 2014
• Last updated: July 25, 2017
• Start date: July 2014
• Est. completion date: September 16, 2016

Study information

• Verified date: July 2017
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Environmental toxins exert damaging health effects in workers. Thousands of responders who worked or volunteered on the World Trade Center (WTC) rescue and recovery effort following the September 11, 2001 attacks suffer from health conditions or may be at increased risk for worsening health. In a pilot study, investigators identified the first evidence of kidney damage in subjects with very high exposure at Ground Zero. Specifically, noted was a preliminary association between the intensity of particulate matter exposure and albuminuria, a marker of early chronic kidney disease (CKD), systemic endothelial dysfunction, and increased cardiovascular risk.

The long-term goal is to minimize the risk of CKD and cardiovascular disease (CVD) among individuals exposed to inhaled toxins. The primary objective of this research is to quantify the risk of kidney damage among first responders to the WTC attack and to determine the relationship to particulate matter exposure as well as determine an association between renal and cardiovascular damage in first responders and to explore potential mechanisms. The central hypothesis is that exposure to inhaled particulate matter causes systemic inflammation and endothelial dysfunction that result in chronic kidney and cardiovascular damage. This hypothesis will be investigated in a subgroup of participants from a previously conducted NIOSH-funded study "Pulmonary Function Abnormalities, Diastolic Dysfunction and WTC Exposure: Implications for Diagnosis and Treatment" ("WTC-CHEST," PI Mary Ann McLaughlin).

The proposed study will capitalize on unique resources in WTC-CHEST, including the standardized collection of data on particulate matter exposure and shared risk factors for CKD and cardiovascular disease, and cardiopulmonary function testing. The output from this proposal is anticipated to have a broad impact on understanding the health effects of inhaled particulate matter.

Description:

Specific Aim 1. To quantify the risk of kidney damage and the relationship to particulate matter exposure among first responders to the WTC attack.

Urine samples will be collected on 2 occasions for albumin and creatinine. The investigators will define clinically relevant albuminuria as a UACR ≥30 mg/g. If, as hypothesized, the investigators find that albuminuria is more common among WTC responders, this simple and non-invasive measure may be useful in monitoring programs to identify responders at increased risk for adverse outcomes. eGFR will be calculated using the Chronic Kidney Disease Epidemiology Consortium (CKD-EPI) equations.

Specific Aim 2. To examine the relationship between kidney damage and cardiac structure and function among first responders to the WTC attack.

Cardiovascular Disease Risk Screening In order to identify an independent relationship between CKD and cardiac dysfunction, the investigators will comprehensively evaluate potential confounders. Participants will undergo an evaluation of traditional CVD risk factors as accounted for in both the Framingham Risk Score and Reynold's score (medical history, medication use and baseline risk for CVD: smoking status, family history of premature coronary disease, blood pressure, heart rate, height, weight, waist, hip and neck circumference). Laboratory evaluation will include: lipid panel, complete blood count, HbA1C, serum creatinine and cystatin C. Standard questionnaires on chest pain, shortness of breath, depression, sleep apnea and stress, IPSS.

Specific Aim 3. To explore potential mechanisms for kidney and cardiovascular damage among first responders to the WTC attack.

An established marker of systemic inflammation, serum hsCRP, will be measured in all participants. Flow-mediated dilatation, a validated non-invasive measure of endothelial function, will be measured in a subgroup of participants. Heavy metal assays will be performed and will be compared between participants with and without evidence of kidney damage (albuminuria or decreased eGFR) or proximal tubular dysfunction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: September 16, 2016
• Est. primary completion date: September 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• WTC responders who were enrolled in the WTC-CHEST program.

• World Trade Center responders who are currently enrolled in the World Trade Center Health Program-Clinical Center of Excellence, formerly known as the WTC Medical Monitoring and Treatment Program

• Over the age of 39 years

Exclusion Criteria:

Related Conditions & MeSH terms

• Cardiac Disease
• Cardiopulmonary Disease
• Cardiovascular Disease
• Cardiovascular Diseases
• Heart Diseases
• Kidney Diseases
• Pulmonary Heart Disease
• Renal Disease

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute for Occupational Safety and Health (NIOSH/CDC)

Country where clinical trial is conducted

United States, 

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* Note: There are 51 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated Glomerular Filtration Rate (eGFR)	Kidney Function - To quantify the risk of kidney damage and the relationship to particulate matter exposure among first responders to the WTC attack.	Day 1
Secondary	Echocardiography	Cardiac structure - To examine the relationship between kidney damage and cardiac structure and function among first responders to the WTC attack.	Day 1
Secondary	Urine Albumin level	Cardiac function - To examine the relationship between kidney damage and cardiac structure and function among first responders to the WTC attack.	Day 1
Secondary	High Sensitivity C-reactive Protein (hsCRP)	Endothelial Dysfunction - To explore potential mechanisms for kidney and cardiovascular damage among first responders to the WTC attack.	Day 1