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

Primary Purpose

Heart Failure, Congestive

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HF Pressure Measurement System
Sponsored by
CardioMEMS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Congestive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CardioMEMS Investigational Sites

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

TREATMENT Group

CONTROL Group

Arm Description

Standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System

Standard of care HF management

Outcomes

Primary Outcome Measures

Rate of Heart Failure Related (HFR) Hospitalizations
Freedom From a Device/System-related Complication (DSRC).
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
Freedom From Pressure Sensor Failure
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

Change From Baseline in Pulmonary Artery Mean Pressure
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.
Proportion of Patients Hospitalized for Heart Failure
Days Alive Outside of the Hospital
Quality of Life - Minnesota Living With Heart Failure Questionnaire (MLHFQ)
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.

Full Information

First Posted
September 18, 2007
Last Updated
January 16, 2015
Sponsor
CardioMEMS
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1. Study Identification

Unique Protocol Identification Number
NCT00531661
Brief Title
CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients
Acronym
CHAMPION
Official Title
CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CardioMEMS

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
550 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TREATMENT Group
Arm Type
Active Comparator
Arm Description
Standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
Arm Title
CONTROL Group
Arm Type
Placebo Comparator
Arm Description
Standard of care HF management
Intervention Type
Device
Intervention Name(s)
HF Pressure Measurement System
Intervention Description
A pressure sensor is intended to be implanted into the pulmonary artery at the time of Swan-Ganz catheterization.
Primary Outcome Measure Information:
Title
Rate of Heart Failure Related (HFR) Hospitalizations
Time Frame
6 months
Title
Freedom From a Device/System-related Complication (DSRC).
Description
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
Time Frame
6 months
Title
Freedom From Pressure Sensor Failure
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change From Baseline in Pulmonary Artery Mean Pressure
Description
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.
Time Frame
6 months
Title
Proportion of Patients Hospitalized for Heart Failure
Time Frame
6 months
Title
Days Alive Outside of the Hospital
Time Frame
6 months
Title
Quality of Life - Minnesota Living With Heart Failure Questionnaire (MLHFQ)
Description
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.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Rate of HFR Hospitalizations
Time Frame
Study duration: average patient follow-up of 15 months
Title
Freedom From a Device/System-related Complication (DSRC)
Time Frame
Study duration: average patient follow-up of 15 months
Title
Freedom From Pressure Sensor Failure
Time Frame
Study duration: average patient follow-up of 15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of HF ≥ 3 months, with either preserved or reduced LVEF Diagnosis of NYHA Class III HF (historical assessment documented at screening visit) 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. At least 1 HF hospitalization within 12 months of Screening Visit Subjects with pulmonary artery branch diameter sized between 7mm and 15mm (implanted vessel) Exclusion Criteria: Subjects with history of recurrent (> 1) pulmonary embolism or deep vein thrombosis Subjects, in the Investigator's opinion, unable to tolerate a right heart catheterization Subjects who have had a major cardiovascular event (e.g., myocardial infarction, stroke) within 2 months of Screening Visit Subjects with Cardiac Resynchronization Device (CRT) implanted ≤ 3 months prior to enrollment Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min who are non-responsive to diuretic therapy or who are on chronic renal dialysis Subjects likely to undergo heart transplantation within 6 months of Screening Visit Subjects with congenital heart disease or mechanical right heart valve(s) Subjects with known coagulation disorders Subjects with a hypersensitivity or allergy to aspirin, and/or clopidogrel
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phillip Adamson, MD, FACC
Organizational Affiliation
Oklahoma Heart Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William T Abraham, MD, FACC
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CardioMEMS Investigational Sites
City
Nationwide
State/Province
Georgia
ZIP/Postal Code
30313
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33626889
Citation
Varma N, Bourge RC, Stevenson LW, Costanzo MR, Shavelle D, Adamson PB, Ginn G, Henderson J, Abraham WT; CHAMPION Investigator Group. Remote Hemodynamic-Guided Therapy of Patients With Recurrent Heart Failure Following Cardiac Resynchronization Therapy. J Am Heart Assoc. 2021 Feb;10(5):e017619. doi: 10.1161/JAHA.120.017619. Epub 2021 Feb 25.
Results Reference
derived
PubMed Identifier
28982501
Citation
Givertz MM, Stevenson LW, Costanzo MR, Bourge RC, Bauman JG, Ginn G, Abraham WT; CHAMPION Trial Investigators. Pulmonary Artery Pressure-Guided Management of Patients With Heart Failure and Reduced Ejection Fraction. J Am Coll Cardiol. 2017 Oct 10;70(15):1875-1886. doi: 10.1016/j.jacc.2017.08.010.
Results Reference
derived
PubMed Identifier
27220593
Citation
Adamson PB, Abraham WT, Stevenson LW, Desai AS, Lindenfeld J, Bourge RC, Bauman J. Pulmonary Artery Pressure-Guided Heart Failure Management Reduces 30-Day Readmissions. Circ Heart Fail. 2016 Jun;9(6):e002600. doi: 10.1161/CIRCHEARTFAILURE.115.002600.
Results Reference
derived
PubMed Identifier
26560249
Citation
Abraham WT, Stevenson LW, Bourge RC, Lindenfeld JA, Bauman JG, Adamson PB; CHAMPION Trial Study Group. Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomised trial. Lancet. 2016 Jan 30;387(10017):453-61. doi: 10.1016/S0140-6736(15)00723-0. Epub 2015 Nov 9.
Results Reference
derived
PubMed Identifier
25813770
Citation
Raina A, Abraham WT, Adamson PB, Bauman J, Benza RL. Limitations of right heart catheterization in the diagnosis and risk stratification of patients with pulmonary hypertension related to left heart disease: insights from a wireless pulmonary artery pressure monitoring system. J Heart Lung Transplant. 2015 Mar;34(3):438-47. doi: 10.1016/j.healun.2015.01.983. Epub 2015 Feb 7.
Results Reference
derived
PubMed Identifier
25286913
Citation
Adamson PB, Abraham WT, Bourge RC, Costanzo MR, Hasan A, Yadav C, Henderson J, Cowart P, Stevenson LW. Wireless pulmonary artery pressure monitoring guides management to reduce decompensation in heart failure with preserved ejection fraction. Circ Heart Fail. 2014 Nov;7(6):935-44. doi: 10.1161/CIRCHEARTFAILURE.113.001229. Epub 2014 Oct 6.
Results Reference
derived
PubMed Identifier
21315441
Citation
Abraham WT, Adamson PB, Bourge RC, Aaron MF, Costanzo MR, Stevenson LW, Strickland W, Neelagaru S, Raval N, Krueger S, Weiner S, Shavelle D, Jeffries B, Yadav JS; CHAMPION Trial Study Group. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet. 2011 Feb 19;377(9766):658-66. doi: 10.1016/S0140-6736(11)60101-3. Erratum In: Lancet. 2012 Feb 4;379(9814):412.
Results Reference
derived

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

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