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The Influence of Aircraft Noise Exposure on Renal Hemodynamic in Healthy Individuals (LÄRM)

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ClinicalTrials.gov Identifier: NCT02783456
Recruitment Status : Recruiting
First Posted : May 26, 2016
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Epidemiological studies have found a link between aircraft noise exposure and increased incidence of arterial hypertension and thus cardiovascular disease. The underlying pathophysiological mechanisms are not yet fully understood. The kidney acts as a long-term regulator of blood pressure and controls the extracellular sodium and water balance. Significant renal mechanisms of blood pressure regulation are the renin angiotensin system, renal sympathetic activity and sodium excretion. Animal work and clinical studies show that mental stress affects the renal plasma flow and urinary sodium excretion. The investigators observed a lower sodium excretion in situations of mental stress in subjects at risk for developing arterial hypertension. In healthy volunteers, a 30-minute mental stress test resulted in increased glomerular filtration rate, filtration fraction and an increase in urinary sodium excretion. In this pilot study the investigators analyzed the influence of 30 minutes standardized aircraft noise on renal and central hemodynamics.

Condition or disease Intervention/treatment
Healthy Individuals Arterial Hypertension Procedure: Noise Procedure: Silence

Detailed Description:

The World Health Organisation (WHO) estimates that (about 340 million population) 1 million annually health life years are lost by environmental noise exposure in high-income countries of Western Europe. Aircraft noise is thereby assessed at comparable volume as unpleasant as road and rail noise. Epidemiological studies have found a link between aircraft noise exposure and increased incidence of arterial hypertension and thus cardiovascular disease. The underlying pathophysiological mechanisms are not yet fully understood.

The kidney acts as a long-term regulator of blood pressure and controls the extracellular sodium and water balance. Significant renal mechanisms of blood pressure regulation are the renin angiotensin system, renal sympathetic activity and sodium excretion. Animal work and clinical studies show that mental stress affects the renal plasma flow and urinary sodium excretion. In spontaneously hypertensive rats environmental stress resulted in sodium retention, triggered by increased renal sympathetic nerve activity, which is the development of arterial hypertension. In a pilot study in subjects at risk for developing arterial hypertension, the investigator observed a lower sodium excretion by mental stress. In healthy volunteers, a 30-minute mental stress test resulted in increased glomerular filtration rate, filtration fraction and an increase in urinary sodium excretion.

In the rabbit noise exposure leads to an increase of frequency and amplitude of discharges of renal sympathetic nerve activity and accompanied by a reduction of renal plasma flow. The impact of aircraft noise on renal plasma flow and urinary sodium excretion has, to our knowledge, so far not been studied in humans.

In this pilot study the Clinical Research Center investigate the influence of 30 minutes standardized aircraft noise on renal hemodynamics.

Hemodynamic renal changes should be considered in the context of the systemic circulation. Therefore, the central hemodynamics is determined in the present pilot study by bioimpedance cardiography.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Care Provider)
Primary Purpose: Diagnostic
Official Title: The Influence of Aircraft Noise Exposure on Renal Hemodynamic in Healthy Individuals
Study Start Date : March 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Noise and silence
Exposition of 80dB flight noise for 30 minutes and 30 minutes silence.
Procedure: Noise
The patient is exposed 30 min to the first sound pattern and during the renal hemodynamics will be measured. The following is a 1-hour break.
Procedure: Silence
The patient is exposed 30 min to the second sound pattern and during the renal hemodynamics will be measured.
Active Comparator: silence and noise
Exposition of 30 minutes silence.and 80dB flight noise for 30 minutes
Procedure: Noise
The patient is exposed 30 min to the first sound pattern and during the renal hemodynamics will be measured. The following is a 1-hour break.
Procedure: Silence
The patient is exposed 30 min to the second sound pattern and during the renal hemodynamics will be measured.


Outcome Measures

Primary Outcome Measures :
  1. change in renal plasma flow (l/min) [ Time Frame: through study completion, an average of 1 year ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with mild-moderate arterial hypertension (grade 1-2)
  • Informed consent in writing available
  • Willing and able to comply with all requirements of the study
  • Male, between 18 and 50 years (inclusive)
  • Body Mass Index (BMI) 18-27 kg/m2
  • Non-smoker
  • Good general health as judged by the Investigator, as determined by medical history, physical examination, vital signs (systolic and diastolic blood pressure and pulse rate) and clinical laboratory parameters (clinical chemistry, hematology, and urinalysis).

Minor deviations of laboratory values, ECG, and vital sign parameters from the normal range may be accepted, if judged by the Investigator to have no clinical relevance.

Additional inclusion criteria for the cohort with arterial hypertension:

- uncomplicated arterial hypertension WHO grade 1-2, office blood pressure 140-179/90-109 mmHg

Exclusion Criteria for healthy individuals:

  • Clinically significant abnormalities in physical examination, vital signs or clinical laboratory parameters (according to the Investigator's judgement).
  • S-GOT or S-GPT levels > 2-times above the upper limit of normal range.
  • eGFR < 60 ml/min/1,73m2 or kidney stones
  • Clinically significant history of cardiovascular disease or any known present cardiovascular disease.
  • History of clinically significant neurological, gastrointestinal, renal, hepatic, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorders.
  • Office blood pressure at screening higher than 140/100 mmHg
  • Office heart rate at screening outside the range of 50-99 beats per minute (inclusive).
  • Regular intake of medication within 1 month prior to study inclusion
  • Participation in any other clinical study within 30 days prior to inclusion in this study.
  • Clinically significant diseases (as judged by the investigator) within four weeks prior to screening
  • History of alcohol or drug abuse.

Exclusion criteria for patients with arterial hypertension:

  • Regular intake of medication within 1 month prior to study inclusion
  • office blood pressure at screening visit > 180/110 mmHg
  • secondary hypertension application of
  • antihypertensive medication within 14 days prior to study inclusion
  • of "other" medication
  • Clinically significant abnormalities in physical examination, vital signs or clinical laboratory parameters (according to the Investigator's judgement).
  • S-GOT or S-GPT levels > 2-times above the upper limit of normal range.
  • eGFR < 60 ml/min/1,73m2 or kidney stones
  • Clinically significant history of cardiovascular disease or any known present cardiovascular disease other than arterial hypertension.
  • History of clinically significant neurological, gastrointestinal, renal, hepatic, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorders, other than arterial hypertension.
  • Office heart rate at screening outside the range of 50-99 beats per minute (inclusive).
  • Regular intake of medication within 1 month prior to study inclusion
  • Participation in any other clinical study within 30 days prior to inclusion in this study.
  • Clinically significant diseases (as judged by the investigator) within four weeks prior to screening, other than arterial hypertension.
  • History of alcohol or drug abuse.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783456


Contacts
Contact: Roland E. Schmieder, Prof. Dr. +49 09131 85 ext 36207 roland.schmieder@uk-erlangen.de

Locations
Germany
University of Erlangen-Nuremberg Recruiting
Erlangen, Bavaria, Germany, 91054
Contact: Roland E Schmieder, Prof.    0049 9131 85 ext 36245    roland.schmieder@uk-erlangen.de   
Principal Investigator: Roland E Schmieder, Prof.         
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Principal Investigator: Roland E. Schmieder, Prof. Dr. University of Erlangen-Nürnberg Medical School
More Information

Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT02783456     History of Changes
Other Study ID Numbers: CRCLÄRM2016
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Erlangen-Nürnberg Medical School:
renal hemodynamic
central hemodynamic
pilot study
flight noise
healthy participant
renal plasma flow
filtration fraction
renal vascular resistance
calculated intra glomerular pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases