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

NCT02783456 | Completed

• 1 other identifier: CRCLÄRM2016
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• change in renal plasma flow (l/min)

  through study completion, an average of 1 year

Study Arms (2)

Noise and silence

ACTIVE COMPARATOR

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

Procedure: Noise; Procedure: Silence

silence and noise

ACTIVE COMPARATOR

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

Procedure: Noise; Procedure: Silence

Interventions

Noise PROCEDURE

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.

Noise and silence; silence and noise

Silence PROCEDURE

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

Noise and silence; silence and noise

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).
• Clinically significant diseases (as judged by the investigator) within four weeks prior to screening
• History of alcohol or drug abuse.
• office blood pressure at screening visit \> 180/110 mmHg
• secondary hypertension application of
• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University of Erlangen-Nuremberg

Erlangen, Bavaria, 91054, Germany

Location

Related Publications (2)

• 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

  RESULT

• Bosch A, Rauh M, Striepe K, Schiffer M, Schmieder RE, Kannenkeril D. Renal adaptation in pre-obesity patients with hypertension. J Hypertens. 2024 Nov 1;42(11):1958-1965. doi: 10.1097/HJH.0000000000003821. Epub 2024 Jul 19.

  PMID: 39248112 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Noise; SIR1 protein, S cerevisiae

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health; Environmental Pollution; Public Health

Study Officials

• Roland E. Schmieder, Prof. Dr.

  University of Erlangen-Nürnberg Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: May 26, 2016
• Study Start: March 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: February 26, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)