The Effect of Short-term Bed Rest on Cardiac Function Measured by Cardiac Magnetic Resonance Imaging

NCT06644872 | Not Yet Recruiting

• 1 other identifier: MRTIME
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to investigate the effect of short-term bed rest (4 hours) on heart function, measured by cardiac magnetic resonance (CMR), in healthy participants. This aim will be addressed through a single-arm repeated study, assessing participants during three hours of bedrest. The hypothesis is that short-term bed rest will decrease cardiac output measured by repeated CMR scans. This study will also investigate the reproducibility of CMR within a narrow time frame. Limited data are available on these aspects, despite their critical importance for conducting consecutive examinations, both in clinical practice and research trials10-12. The study also aims to investigate the appliances of short-time measures of cardiac function.

Conditions

Rest; Healthy

Keywords

Cardiac output; bedrest; Healthy

Outcome Measures

Primary Outcomes (1)

• cardiac output

  Change in cardiac output will be measured assessed by repeated cardiac magnetic resonance measurement after shortterm bed rest compared with before bedrest.

  0-4 hours

Secondary Outcomes (1)

• Left ventricular ejection fraction

  0-4 hours

Study Arms (1)

Cardiac magnetic resonance measurements

EXPERIMENTAL

Healthy participants will undergo a three and half-hour experimental day including repeated measurements of cardiac magnetic resonance and blood sampling.

Other: Bedrest

Interventions

Bedrest OTHER

Investigation of the effect of short-term bed rest (3 hours) on heart function, measured by cardiac magnetic resonance, in healthy participants ( males and females)

Cardiac magnetic resonance measurements

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female.
• Age between 18-80 years old.
• No use of medications with influence on heart function.
• For ethical reasons, we only include participants who are willing to be informed on new health information, as CMR may reveal relevant secondary health findings.

You may not qualify if:

• Diabetes, kidney, or liver disease.
• Contraindications to CMR, e.g., abdominal height exceed limitations of the MR-scanner, pacemaker, aortastent, neurostimulator, or other electronic device implanted, implanted metal devices, severe claustrophobia, or physiological diseases.
• Pregnant, lactating, or planning to become pregnant within the study period.
• In ongoing cancer treatment.
• Blood donation during and \< 1 month prior to study.
• Simultaneous participation in other clinical trials potentially affecting the study outcome.
• Inability, physically or mentally, to comply with the procedure required by the study protocol ad evaluated by the primary investigator, study manager or clinical responsible.

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

University of Copenhagen

Copenhagen, 2100, Denmark

Location

MeSH Terms

Interventions

Bed Rest

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Bente Kiens, D.sci, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bente Kiens, D Sci, PhD

CONTACT

+4528751619; bkiens@nexs.ku.dk

Andreas M Fritzen, PhD

CONTACT

+4542633359; amfritzen@sund.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: single-arm repeated measurement study

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 16, 2024
• Study Start: October 15, 2024
• Primary Completion: May 31, 2025
• Study Completion (Estimated): January 1, 2029
• Last Updated: October 16, 2024

Record last verified: 2024-06

Locations

DK (1)