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

October 20, 2015 updated by: Finn Gustafsson

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Dept. of Cardiology, Rigshospitalet, University Hospital of Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of hemodynamic parameters
Time Frame: minutes
Invasive measurements using Swan-Ganz catheters and echocardiography will provide the data needed.
minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Finn Gustafsson

Investigators

  • Principal Investigator: Finn Gustafsson, M.D. Msc, Chief Physician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

October 22, 2013

First Submitted That Met QC Criteria

October 27, 2013

First Posted (Estimate)

November 1, 2013

Study Record Updates

Last Update Posted (Estimate)

October 22, 2015

Last Update Submitted That Met QC Criteria

October 20, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-2-2013-072

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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