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Completed

NCT Number: NCT01974557

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

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.

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Key information

Conditions

Hemodynamics Heart Murmurs Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Cardiology, Rigshospitalet, University Hospital of Denmark

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Exercise

Other

Primary outcomes

  1. Composite of hemodynamic parameters

    Time frame: minutes

    Invasive measurements using Swan-Ganz catheters and echocardiography will provide the data needed.

Secondary outcomes

  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.

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Finn Gustafsson

Other

Registry information

Acronym: HemReX

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 1, 2013
Registry last updated
Oct 22, 2015

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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