Prospective Observation of Exercise Parameters in Advanced Heart Failure
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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 |
- 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:
|
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 |
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.
Inclusion Criteria:
- Age ≥18 years
- Advanced heart failure suspected or diagnosed
Exclusion Criteria:
- Inability to ambulate at least one block
- Angina that has developed or a changed in pattern/symptoms since last physician visit.
- Recent life-threatening arrhythmia or diagnosis that suggests high-risk of exacerbation of arrhythmia with exercise (catecholaminergic polymorphic ventricular tachycardia, e.g.)
- LVAD driveline infection or suspected driveline infection
- Medical activity restriction that precludes ambulation
Contacts and Locations| Contact: Peter M Eckman, MD | 612-626-5320 | eckmanp@umn.edu |
| Contact: Aimee V Hamel, RN | 612-626-4726 | ahamel@umn.edu |
| 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 | |
| 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 May 23, 2013