Prospective Observation of Exercise Parameters in Advanced Heart Failure

NCT01210573 | Completed

• 1 other identifier: 1002M77542
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Heart Failure; Heart-Assist Devices; Left Ventricular Assist Device

Outcome Measures

Primary Outcomes (1)

• Sub-maximal exercise ventilation parameters

  Observational investigation of sub-maximal exercise ventilation parameters in patient diagnosed with, or suspected to have, advanced heart failure.

  Pre and Post-LVAD placement

Study Arms (1)

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

Interventions

adjustment of LVAD or pacemaker DEVICE

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.

Also known as: HeartMate 2, HeartWare, Biventricular pacemaker

Device adjustment

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years
• Advanced heart failure suspected or diagnosed

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• Shape Medical Systems, Inc.: collaborator

Study Sites (1)

Masonic Clinical Research Unit

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy Devices

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pacemaker, Artificial; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Peter M Eckman, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2010
• First Posted: September 28, 2010
• Study Start: April 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 18, 2014

Record last verified: 2014-12

Locations

US (1)