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CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients (CHAMPION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00531661
Recruitment Status : Completed
First Posted : September 19, 2007
Results First Posted : April 9, 2013
Last Update Posted : January 28, 2015
Sponsor:
Information provided by (Responsible Party):
CardioMEMS

Study Description
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Brief Summary:
This is a prospective, multi-center, randomized, single-blind clinical trial conducted in the United States (US). The objective of the study is to evaluate the safety and efficacy of the HF Pressure Measurement System in reducing heart failure (HF) related hospitalizations in a subset of subjects suffering from HF.

Condition or disease Intervention/treatment Phase
Heart Failure, Congestive Device: HF Pressure Measurement System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients
Study Start Date : September 2007
Actual Primary Completion Date : May 2010
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: TREATMENT Group
Standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
 Device: HF Pressure Measurement System
A pressure sensor is intended to be implanted into the pulmonary artery at the time of Swan-Ganz catheterization.
Placebo Comparator: CONTROL Group
Standard of care HF management


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Heart Failure Related (HFR) Hospitalizations [ Time Frame: 6 months ]
  2. Freedom From a Device/System-related Complication (DSRC). [ Time Frame: 6 months ]

    A DSRC is an adverse event that is, or is possibly, related to the HF Pressure Measurement System and at least one the following:

    • is treated with invasive means (other than intramuscular medication or a right heart catheterization with a Swan-Ganz measurement which is used for diagnostic purposes)
    • results in the death of the subject
    • results in the explant of the device

  3. Freedom From Pressure Sensor Failure [ Time Frame: 6 months ]
    A pressure sensor failure occurs when the sensor malfunctions to the point that no readings can be obtained from it after all attempts are exhausted including troubleshooting the system to rule out any problems with the electronic components.


Secondary Outcome Measures :
  1. Change From Baseline in Pulmonary Artery Mean Pressure [ Time Frame: 6 months ]
    Change from baseline in pulmonary artery mean pressure was calculated using an area under the curve (AUC) methodology. All patients were instructed to take daily home readings for 180 days. By patient, a baseline average for the first 7 days of home readings was calculated. The difference between baseline and each daily reading was then determined and a corresponding daily AUC value was calculated. Finally, all daily AUC values were summed over the entire 180 day period resulting in a total AUC per patient. These data were aggregated for each randomization group and then compared. The unit of measure is mmHg x Days.

  2. Proportion of Patients Hospitalized for Heart Failure [ Time Frame: 6 months ]
  3. Days Alive Outside of the Hospital [ Time Frame: 6 months ]
  4. Quality of Life - Minnesota Living With Heart Failure Questionnaire (MLHFQ) [ Time Frame: 6 months ]
    THe MLHFQ is patient self-assessment of how heart failure affects his or her daily life. To measure the effects of symptoms, functional limitations, psychological distress on an individual's quality of life, the MLHFQ questionnaire asks each person to indicate using a 6-point, zero to five, Likert scale how much each of 21 facets prevented them from living as they desired. Total scores are provided as sums. The total score scale range is 0 - 105. A lower total score is indicative of better quality of life.


Other Outcome Measures:
  1. Rate of HFR Hospitalizations [ Time Frame: Study duration: average patient follow-up of 15 months ]
  2. Freedom From a Device/System-related Complication (DSRC) [ Time Frame: Study duration: average patient follow-up of 15 months ]
  3. Freedom From Pressure Sensor Failure [ Time Frame: Study duration: average patient follow-up of 15 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of HF ≥ 3 months, with either preserved or reduced LVEF
  2. Diagnosis of NYHA Class III HF (historical assessment documented at screening visit)
  3. Subjects with reduced LVEF must be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the subject is intolerant to beta blockers, ACE-I or ARB. Beta blockers and ACE-I (or ARB) doses should be stable for one month prior to study entry.
  4. At least 1 HF hospitalization within 12 months of Screening Visit
  5. Subjects with pulmonary artery branch diameter sized between 7mm and 15mm (implanted vessel)

Exclusion Criteria:

  1. Subjects with history of recurrent (> 1) pulmonary embolism or deep vein thrombosis
  2. Subjects, in the Investigator's opinion, unable to tolerate a right heart catheterization
  3. Subjects who have had a major cardiovascular event (e.g., myocardial infarction, stroke) within 2 months of Screening Visit
  4. Subjects with Cardiac Resynchronization Device (CRT) implanted ≤ 3 months prior to enrollment
  5. Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min who are non-responsive to diuretic therapy or who are on chronic renal dialysis
  6. Subjects likely to undergo heart transplantation within 6 months of Screening Visit
  7. Subjects with congenital heart disease or mechanical right heart valve(s)
  8. Subjects with known coagulation disorders
  9. Subjects with a hypersensitivity or allergy to aspirin, and/or clopidogrel
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00531661


Locations
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United States, Georgia
CardioMEMS Investigational Sites
Nationwide, Georgia, United States, 30313
Sponsors and Collaborators
CardioMEMS
Investigators
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Principal Investigator: Phillip Adamson, MD, FACC Oklahoma Heart Hospital
Principal Investigator: William T Abraham, MD, FACC Ohio State University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: CardioMEMS
ClinicalTrials.gov Identifier: NCT00531661    
Other Study ID Numbers: CM-06-04
First Posted: September 19, 2007    Key Record Dates
Results First Posted: April 9, 2013
Last Update Posted: January 28, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases