Clinical trial NCT00531661: CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients
Official title: CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Congestive
Lead sponsor: CardioMEMS
Sponsor class: INDUSTRY
First posted: 2007-09-19
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Rate of Heart Failure Related (HFR) Hospitalizations
timeFrame: 6 months
measure: Freedom From a Device/System-related Complication (DSRC).
timeFrame: 6 months
measure: Freedom From Pressure Sensor Failure
timeFrame: 6 months
Secondary outcomes:
measure: Change From Baseline in Pulmonary Artery Mean Pressure
timeFrame: 6 months
measure: Proportion of Patients Hospitalized for Heart Failure
timeFrame: 6 months
measure: Days Alive Outside of the Hospital
timeFrame: 6 months
measure: Quality of Life - Minnesota Living With Heart Failure Questionnaire (MLHFQ)
timeFrame: 6 months
Other outcomes:
measure: Rate of HFR Hospitalizations
timeFrame: Study duration: average patient follow-up of 15 months
measure: Freedom From a Device/System-related Complication (DSRC)
timeFrame: Study duration: average patient follow-up of 15 months
measure: Freedom From Pressure Sensor Failure
timeFrame: Study duration: average patient follow-up of 15 months
Locations:
city: Nationwide
country: United States
facility: CardioMEMS Investigational Sites
state: Georgia
Study officials:
affiliation: Oklahoma Heart Hospital
name: Phillip Adamson, MD, FACC
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: William T Abraham, MD, FACC
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.