Heart Failure, CongestiveCHAMPIONNCT00531661

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

A study testing HF Pressure Measurement System in people with Heart Failure, Congestive, run by CardioMEMS at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure, Congestive
What is being tested?: HF Pressure Measurement System
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 550 participants
Where: 1 siteUnited States
Study dates: Sep 2007to Nov 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

CardioMEMS Investigational Sites
Nationwide, Georgia, 30313

Other trials in United States

About this study

Conditions: Heart Failure, Congestive
Being tested: HF Pressure Measurement System
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HF Pressure Measurement SystemDevice
A pressure sensor is intended to be implanted into the pulmonary artery at the time of Swan-Ganz catheterization.

Study groups in NCT00531661
Study group	Role	What they receive
TREATMENT Group	Active comparator	Standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System Receives: Device: HF Pressure Measurement System
CONTROL Group	Placebo comparator	Standard of care HF management

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of Heart Failure Related (HFR) Hospitalizations
Measured: 6 months
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
Measured: 6 months
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.
Measured: 6 months

Secondary outcomes (4)

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.
Measured: 6 months
Proportion of Patients Hospitalized for Heart Failure
Measured: 6 months
Days Alive Outside of the Hospital
Measured: 6 months
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.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2007Nov 2014

First posted19 Sep 2007 (estimated)
Study startSep 2007
Primary completionMay 2010
Study completionNov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 550 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00531661
Sponsor's protocol ID: CM-06-04
Acronym: CHAMPION
Status last verified: Jan 2015
First submitted: 18 Sep 2007
Last updated: 28 Jan 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Zile MR, Abraham WT, Stevenson LW, Costanzo MR, Angermann CE, Mehra MR, Desai AS, Ducharme A, Johnson N, Henderson J, Lindenfeld J. Relationship Between Remote, Ambulatory Pulmonary Artery Pressures, and All-Cause Mortality in Patients With Chronic Heart Failure. Circ Heart Fail. 2025 Jun;18(6):e012754. doi: 10.1161/CIRCHEARTFAILURE.124.012754. Epub 2025 Apr 14.
PubMed 40223608
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.
PubMed 33626889
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.
PubMed 28982501
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.
PubMed 27220593
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.
PubMed 26560249
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.
PubMed 25813770
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.
PubMed 25286913
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.
PubMed 21315441

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study of Bimagrumab in Participants With HFpEF
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Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
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Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

All Heart Failure, Congestive trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients
ClinicalTrials.gov ID: NCT00531661
Acronym / sponsor ID: CHAMPION / CM-06-04
Conditions: Heart Failure, Congestive
Study type: Interventional
Recruitment status: Completed
Enrolment: 550 participants (actual)
Lead sponsor: CardioMEMSIndustry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: May 2010 (actual)
Study completion: Nov 2014 (actual)
First posted: 19 Sep 2007 (estimated)
Results: Posted 9 Apr 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
TREATMENT Group	Active comparator	Device: HF Pressure Measurement SystemStandard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
CONTROL Group	Placebo comparator	–Standard of care HF management

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HF Pressure Measurement SystemA pressure sensor is intended to be implanted into the pulmonary artery at the time of Swan-Ganz catheterization.	Device	TREATMENT Group

Primary outcome

Rate of Heart Failure Related (HFR) Hospitalizations
Time frame: 6 months
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
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.

4 secondary outcomes

Change From Baseline in Pulmonary Artery Mean Pressure
Time frame: 6 months
Proportion of Patients Hospitalized for Heart Failure
Time frame: 6 months
Days Alive Outside of the Hospital
Time frame: 6 months
Quality of Life - Minnesota Living With Heart Failure Questionnaire (MLHFQ)
Time frame: 6 months

Results and safety

Results posted to the registry on 9 Apr 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	270	244
Control	280	254

Primary outcome: Rate of Heart Failure Related (HFR) Hospitalizations

Time frame: 6 months. Number. Unit: HFR hospitalizations/patient/6 months

Measure	Treatment n = 270	Control n = 280
Value	0.32	0.44

Treatment vs Control: p = 0.0002, Negative Binomial Regression

Primary outcome: Freedom From a Device/System-related Complication (DSRC).

Time frame: 6 months. Number. Unit: cases

Measure	Entire Study Cohort n = 550
Value	567 (97.3% to 99.4%)

Entire Study Cohort: p <0.0001, exact test of binomial proportions

Population analysed: This Safety Endpoint was prespecified as an aggregate analysis of all patients implanted with the device as well as patients where an implant was attempted. Results are not presented as an inter-arm comparison but rather against an objective performance criteria (OPC). This population includes 550 implanted patients + 25 patient attempts.

Primary outcome: Freedom From Pressure Sensor Failure

Time frame: 6 months. Number. Unit: participants

Measure	Entire Randomized Study Cohort n = 550
Value	550

Entire Randomized Study Cohort: p <0.0001, exact test of binomial proportions

Population analysed: This Safety Endpoint was prespecified as an aggregate analysis of all patients implanted with the device. Results are not presented as an inter-arm comparison but rather against an objective performance criteria (OPC).

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	121 of 270 (44.8%)	175 of 270 (64.8%)	Not reported
Control	155 of 280 (55.4%)	174 of 280 (62.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40223608Zile MR, Abraham WT, Stevenson LW, Costanzo MR, Angermann CE, Mehra MR, Desai AS, Ducharme A, Johnson N, Henderson J, Lindenfeld J. Relationship Between Remote, Ambulatory Pulmonary Artery Pressures, and All-Cause Mortality in Patients With Chronic Heart Failure. Circ Heart Fail. 2025 Jun;18(6):e012754. doi: 10.1161/CIRCHEARTFAILURE.124.012754. Epub 2025 Apr 14.
Derived from this study: PubMed 33626889Varma 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.
Derived from this study: PubMed 28982501Givertz 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.
Derived from this study: PubMed 27220593Adamson 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.
Derived from this study: PubMed 26560249Abraham 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.
Derived from this study: PubMed 25813770Raina 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.
Derived from this study: PubMed 25286913Adamson 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.
Derived from this study: PubMed 21315441Abraham 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.

Related trials for Heart Failure, Congestive

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Phillip Adamson, MD, FACC principal investigator

Oklahoma Heart Hospital

William T Abraham, MD, FACC principal investigator

Ohio State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing HF Pressure Measurement System in people with Heart Failure, Congestive, run by CardioMEMS at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Heart Failure Related (HFR) Hospitalizations (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00531661, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2015.