Prospective Observation of Exercise Parameters in Advanced Heart Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborator:
Shape Medical Systems, Inc.
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01210573
First received: September 27, 2010
Last updated: March 20, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Advanced Heart Failure
Device: adjustment of LVAD or pacemaker

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Observation of Exercise Parameters in Advanced Heart Failure

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Sub-maximal exercise ventilation parameters [ Time Frame: Pre and Post-LVAD placement ] [ Designated as safety issue: No ]
    Observational investigation of sub-maximal exercise ventilation parameters in patient diagnosed with, or suspected to have, advanced heart failure.


Estimated Enrollment: 20
Study Start Date: April 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Device adjustment
Advanced or suspected advanced heart failure. Most are anticipated to have severely depressed ejection fraction (<30% and typically <20%), but patients with preserved ejection fraction and either hypertrophy or restrictive cardiomyopathy will also be eligible. Patients pulmonary hypertension, on any therapy (other than diuretics alone), are also felt to be at high risk of developing right heart failure and may also be included. Patients who have already undergone LVAD or cardiac transplant are also considered to have advanced heart failure and are eligible to participate, regardless of the severity of their symptoms at the time of enrollment.
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.

Other Names:
  • HeartMate 2
  • HeartWare
  • Biventricular pacemaker

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with, or suspected to have, advanced heart failure and who meet inclusion and exclusion criteria are eligible for participation. Those who have undergone LVAD implantation, heart transplantation or are on the transplant list, and those with biventricular pacemaker who meet study criteria are also eligible for study participation. Patients diagnosed with pulmonary hypertension and therefore at risk for developing right sided heart failure may also be included.

Criteria

Inclusion Criteria:

  1. Age ≥18 years
  2. Advanced heart failure suspected or diagnosed

Exclusion Criteria:

  1. Inability to ambulate at least one block
  2. Angina that has developed or a changed in pattern/symptoms since last physician visit.
  3. Recent life-threatening arrhythmia or diagnosis that suggests high-risk of exacerbation of arrhythmia with exercise (catecholaminergic polymorphic ventricular tachycardia, e.g.)
  4. LVAD driveline infection or suspected driveline infection
  5. Medical activity restriction that precludes ambulation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01210573

Contacts
Contact: Peter M Eckman, MD 612-626-5320 eckmanp@umn.edu
Contact: Aimee V Hamel, RN 612-626-4726 ahamel@umn.edu

Locations
United States, Minnesota
Masonic Clinical Research Unit Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Peter M Eckman, MD    612-626-5320    eckmanp@umn.edu   
Contact: Marco A Caccamo, DO    612-626-2451    cacca002@umn.edu   
Principal Investigator: Peter M Eckman, MD         
Sub-Investigator: Marco A Caccamo, DO         
Sub-Investigator: Patricia Painter, PhD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Shape Medical Systems, Inc.
Investigators
Principal Investigator: Peter M Eckman, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01210573     History of Changes
Other Study ID Numbers: 1002M77542
Study First Received: September 27, 2010
Last Updated: March 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Heart Failure
Heart-Assist Devices
Left Ventricular Assist Device

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014