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

Primary Purpose

Healthy Individuals, Arterial Hypertension

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Noise

Silence

About this trial

This is an interventional diagnostic trial for Healthy Individuals focused on measuring renal hemodynamic, central hemodynamic, pilot study, flight noise, healthy participant, renal plasma flow, filtration fraction, renal vascular resistance, calculated intra glomerular pressure

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

University of Erlangen-Nuremberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Noise and silence

silence and noise

Arm Description

Exposition of 80dB flight noise for 30 minutes and 30 minutes silence.

Exposition of 30 minutes silence.and 80dB flight noise for 30 minutes

Outcomes

Primary Outcome Measures

change in renal plasma flow (l/min)

Secondary Outcome Measures

Full Information

NCT ID

NCT02783456

First Posted

April 27, 2016

Last Updated

February 22, 2018

Sponsor

University of Erlangen-Nürnberg Medical School

1. Study Identification

Unique Protocol Identification Number

NCT02783456

Brief Title

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

Acronym

LÄRM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

March 2016 (undefined)

Primary Completion Date

January 2018 (Actual)

Study Completion Date

January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Erlangen-Nürnberg Medical School

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Individuals, Arterial Hypertension

Keywords

renal hemodynamic, central hemodynamic, pilot study, flight noise, healthy participant, renal plasma flow, filtration fraction, renal vascular resistance, calculated intra glomerular pressure

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Care Provider

Allocation

Randomized

Enrollment

86 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Noise and silence

Arm Type

Active Comparator

Arm Description

Exposition of 80dB flight noise for 30 minutes and 30 minutes silence.

Arm Title

silence and noise

Arm Type

Active Comparator

Arm Description

Exposition of 30 minutes silence.and 80dB flight noise for 30 minutes

Intervention Type

Procedure

Intervention Name(s)

Noise

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Silence

Intervention Description

The patient is exposed 30 min to the second sound pattern and during the renal hemodynamics will be measured.

Primary Outcome Measure Information:

Title

change in renal plasma flow (l/min)

Time Frame

through study completion, an average of 1 year

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roland E. Schmieder, Prof. Dr.

Organizational Affiliation

University of Erlangen-Nürnberg Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Erlangen-Nuremberg

City

Erlangen

State/Province

Bavaria

ZIP/Postal Code

91054

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Citations:

Citation

A. Jumar, C. Ott, J.M. Harazny, K. Striepe, M.V. Karg, R.E. Schmieder. NEW MODEL TO INVESTIGATE THE INFLUENCE OF AIRCRAFT NOISE IN THE PATHOPHYSIOLOGICAL CONCEPT OF HYPERTENSION J Hypertens 2017;35, e-Supplement 2:e214 PP.15.32

Results Reference

result

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

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