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

Hemodynamics Clinical Trial

— HemReX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01974557
• Other study ID #: H-2-2013-072
• Status: Completed
• Phase: N/A
• First received: October 22, 2013
• Last updated: October 20, 2015
• Start date: October 2013
• Est. completion date: July 2015

Study information

• Verified date: October 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The National Committee on Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hemodynamics

Intervention

Other:
• Exercise

Locations

Country	Name	City	State
Denmark	Dept. of Cardiology, Rigshospitalet, University Hospital of Denmark	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Finn Gustafsson

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of hemodynamic parameters	Invasive measurements using Swan-Ganz catheters and echocardiography will provide the data needed.	minutes	No
Secondary	Composite of humoral markers	Blood samples will be analysed with regard to humoral peptides and hormones that may affect hemodynamics.	up to 1 hour	No