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The Effect of Age on the Hemodynamic Response During Rest and Exercise in Healthy Humans (HemReX)

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ClinicalTrials.gov Identifier: NCT01974557
Recruitment Status : Completed
First Posted : November 1, 2013
Last Update Posted : October 22, 2015
Sponsor:
Information provided by (Responsible Party):
Finn Gustafsson, Rigshospitalet, Denmark

Brief Summary:

Primary: To observe how hemodynamic parameters are affected by age during rest and exercise in healthy humans. Furthermore, how an acute fluid challenge changes hemodynamic parameters.

Secondary: To thoroughly examine this population with regard to cardiac performance and function, anthropometrics, metabolic status, exercise capability, constitution, pulmonary status, and humoral markers of organ functions. This population will serve as a healthy control group, to which different populations can be compared, hence the need for a comprehensive characterization.

Hypotheses:

Diastolic function and parameters associated with diastolic function gradually deteriorate with increasing age. The gradual deterioration is unmasked at an earlier age during exercise and fluid challenge, compared to measurements made at rest.


Condition or disease Intervention/treatment Phase
Hemodynamics Other: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Age on the Hemodynamic Response During Rest and Exercise in Healthy Humans
Study Start Date : October 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

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Primary Outcome Measures :
  1. Composite of hemodynamic parameters [ Time Frame: minutes ]
    Invasive measurements using Swan-Ganz catheters and echocardiography will provide the data needed.


Secondary Outcome Measures :
  1. Composite of humoral markers [ Time Frame: up to 1 hour ]
    Blood samples will be analysed with regard to humoral peptides and hormones that may affect hemodynamics.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age over 18 years
  • No acute or chronic diseases that can influence hemodynamics
  • Pause in medication with effect on hemodynamics 24h before experimental day
  • Echocardiography, with no structural abnormalities with an impact on hemodynamics.
  • ECG without any pathological findings, including arrhythmia
  • Normal red and white blood count, normal renal, liver, thyroid, immune, and hematological function as well as normal electrolytes, HbA1c and natriuretic peptides
  • Ability to perform graded bicycle exercise testing
  • BMI in the range of 20-30 kg/m2
  • Height within population mean ±2 standard deviations
  • VO2-max within population mean ±2 standard deviations (age corrected)
  • Acceptable sonographic conditions
  • Informed consent

Exclusion Criteria:

  • History of heart failure (verified or suspected), or heart failure verified by pathological left and right systolic and diastolic measurements of the heart
  • Hypotension (systolic blood pressure < 100 mmHg)
  • Inability to participate
  • Pregnant women
  • Diabetes

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): NCT01974557


Locations
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Denmark
Dept. of Cardiology, Rigshospitalet, University Hospital of Denmark
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Finn Gustafsson
Investigators
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Principal Investigator: Finn Gustafsson, M.D. Msc Chief Physician

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Responsible Party: Finn Gustafsson, Chief Physician, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01974557     History of Changes
Other Study ID Numbers: H-2-2013-072
First Posted: November 1, 2013    Key Record Dates
Last Update Posted: October 22, 2015
Last Verified: October 2015

Keywords provided by Finn Gustafsson, Rigshospitalet, Denmark:
Cardiac physiology
ageing
gender differences
diastole
fluid challenge