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NCT Number: NCT02246101

World Trade Center (WTC) RENAL

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.

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Key information

Conditions

Cardiac Disease Albuminuria Cardiopulmonary Disease Cardiovascular Disease Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Kidney Diseases Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Proteinuria Pulmonary Heart Disease Renal Disease Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

  1. Estimated Glomerular Filtration Rate (eGFR)

    Time frame: Day 1

    Kidney Function - To quantify the risk of kidney damage and the relationship to particulate matter exposure among first responders to the WTC attack.

Secondary outcomes

  1. Echocardiography

    Time frame: Day 1

    Cardiac structure - To examine the relationship between kidney damage and cardiac structure and function among first responders to the WTC attack.

  2. Urine Albumin level

    Time frame: Day 1

    Cardiac function - To examine the relationship between kidney damage and cardiac structure and function among first responders to the WTC attack.

  3. High Sensitivity C-reactive Protein (hsCRP)

    Time frame: Day 1

    Endothelial Dysfunction - To explore potential mechanisms for kidney and cardiovascular damage among first responders to the WTC attack.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Institute for Occupational Safety and Health (NIOSH/CDC)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 22, 2014
Registry last updated
Jul 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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