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Prospective Observation of Exercise Parameters in Advanced Heart Failure

NCT01210573 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2014-12-18

No results posted yet for this study

Summary

To observe and document ventilation parameters in the advanced heart failure population, through the course of illness, which often includes cardiac resynchronization therapy (CRT), left ventricular assist device (LVAD), and transplant. Findings from this cohort are anticipated to be of sufficient interest to the scientific community to merit publication and are likely to provide preliminary data for future hypothesis generation and subsequent prospective, randomized controlled trials.

A compact, inexpensive apparatus has recently become commercially available for performing sub-maximal exercise testing (SHAPE Medical, St Paul, MN), including gas exchange analysis and will be used in this study. This apparatus is not investigational.

Conditions

  • Advanced Heart Failure

Interventions

DEVICE

adjustment of LVAD or pacemaker

For patients without a device: Patients start at rest for 2 minutes and will wear a face mask and breathing parameters are recorded using the SHAPE-HF system (SHAPE Medical St. Paul, MN) that measures respiratory airflow and the constituent respiratory gases, oxygen and carbon dioxide. For patients with a device: patients will be at rest and the adjustments of their device will be made by a study physician or device coordinator, done routinely in clinical practice. This will take up to 15 minutes and during this time; participants will wear a face mask and breathing parameters are recorded using the SHAPE-HF system (SHAPE Medical St. Paul, MN) that measures respiratory airflow and the constituent respiratory gases, oxygen and carbon dioxide.

Sponsors & Collaborators

Principal Investigators

  • Peter M Eckman, MD · University of Minnesota

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01210573 on ClinicalTrials.gov