Heart Failure Clinical Trial
— GUIDE-HFOfficial title:
Hemodynamic-GUIDEd Management of Heart Failure
NCT number | NCT03387813 |
Other study ID # | CIP-10170 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 15, 2018 |
Est. completion date | May 17, 2023 |
Verified date | August 2022 |
Source | Abbott Medical Devices |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for future HF events or mortality.
Status | Completed |
Enrollment | 2358 |
Est. completion date | May 17, 2023 |
Est. primary completion date | May 17, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Diagnosis and treatment for heart failure (HF) (regardless of left ventricular ejection fraction (LVEF)) for > 90 days prior to the date of consent: a. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current American Heart Association (AHA)/American College of Cardiology (ACC) guidelines as standard-of-care for HF therapy in the United States, with any intolerance documented. 2. GUIDE-HF Randomized Arm Only: NYHA Class II, III or IV HF symptoms documented within 30 days prior to consent. 3. GUIDE-HF Single Arm Only: NYHA Class III HF symptoms documented within 30 days prior to consent. 4. HF hospitalization (HFH) within 12 months prior to consent and/or elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or Brain Natriuretic Peptide (BNP)) within 30 days prior to consent defined as: 1. Subjects with LVEF = 40%: NT-proBNP = 1000 pg/mL (or BNP = 250 pg/mL). 2. Subjects with LVEF > 40%: NT-proBNP = 700 pg/mL (or BNP = 175 pg/mL). 3. Thresholds for NT-proBNP and BNP (for both LVEF = 40% and LVEF > 40%) will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2 5. = 18 years of age 6. Chest circumference of < 65 inches, if BMI is > 35 kg/m2 7. Written informed consent obtained from subject 8. Willing and able to upload pulmonary artery (PA) pressure information and comply with the follow-up requirements Exclusion Criteria: 1. Intolerance to all neuro-hormonal antagonists (i.e., intolerance to angiotensin converting enzyme-inhibitors (ACE-I), angiotensin receptor blockers (ARB), angiotensin-neprilysin inhibitors (ARNi), hydralazine/isosorbide dinitrate and beta-blockers) 2. ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes) 3. Received or are likely to receive an advanced therapy (e.g., mechanical circulatory support or cardiac transplant) in the next 12 months 4. NYHA Class IV HF patients with: 1. Continuous or chronic use of scheduled intermittent inotropic therapy for HF and an INTERMACS level of = 4, OR 2. Persistence of fluid overload with maximum (or dose equivalent) diuretic intervention 5. Glomerular Filtration Rate (eGFR) < 25 mL/min and non-responsive to diuretic therapy, or receiving chronic dialysis 6. Inability to tolerate or receive dual antiplatelet therapy or anticoagulation therapy for one month post-implantation 7. Significant congenital heart disease that has not been repaired and would prevent implantation of the CardioMEMS™ PA Sensor 8. Implanted with mechanical right heart valve(s) 9. Unrepaired severe valvular disease 10. Pregnant or planning to become pregnant in the next 12 months 11. An active, ongoing infection, defined as being febrile, an elevated white blood cell count, on intravenous antibiotics, and/or positive cultures (blood, sputum or urine). 12. History of current or recurrent (= 2 episodes within 5 years prior to consent) pulmonary emboli and/or deep vein thrombosis 13. Major cardiovascular event (e.g., unstable angina, myocardial infarction, percutaneous coronary intervention, open heart surgery, or stroke, etc.) within 90 days prior to consent 14. Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to consent 15. Enrollment into another trial with an active treatment arm 16. Anticipated life expectancy of < 12 months 17. Any condition that, in the opinion of the Investigator, would not allow for utilization of the CardioMEMS™ HF System to manage the subject using information gained from hemodynamic measurements to adjust medications, including the presence of unexpectedly severe pulmonary hypertension (e.g., trans-pulmonary gradient >15) at implant right heart catheterization (RHC), a history of non-compliance, or any condition that would preclude CardioMEMS™ PA Sensor implantation |
Country | Name | City | State |
---|---|---|---|
Canada | Foothills Medical Centre | Calgary | Alberta |
Canada | Southlake Regional Health Centre | Newmarket | Ontario |
Canada | Toronto General Hospital | Toronto | Ontario |
Canada | Vancouver General Hospital (U of BC) | Vancouver | British Columbia |
United States | Abington Memorial Hospital | Abington | Pennsylvania |
United States | Akron City Hospital | Akron | Ohio |
United States | New Mexico Heart Institute | Albuquerque | New Mexico |
United States | University of Michigan | Ann Arbor | Michigan |
United States | Piedmont Athens Regional Medical Center | Athens | Georgia |
United States | McLaren Health Care Corporation | Auburn Hills | Michigan |
United States | University Hospital | Augusta | Georgia |
United States | University of Colorado Hospital | Aurora | Colorado |
United States | Acension Texas Cardiovascular | Austin | Texas |
United States | Austin Heart | Austin | Texas |
United States | Our Lady of the Lake Hospital | Baton Rouge | Louisiana |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Bethesda Memorial Hospital | Boynton Beach | Florida |
United States | Deborah Heart and Lung Center | Browns Mills | New Jersey |
United States | Carolinas Medical Center | Charlotte | North Carolina |
United States | Morton Plant Hospital | Clearwater | Florida |
United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
United States | Prisma Health-Midlands | Columbia | South Carolina |
United States | Ohio Health Research Institute | Columbus | Ohio |
United States | Ohio State University | Columbus | Ohio |
United States | John Muir Medical Center | Concord | California |
United States | Baylor University Hospital | Dallas | Texas |
United States | Adventist Health St. Helena | Deer Park | California |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Northshore University HealthSystem | Evanston | Illinois |
United States | Providence Everett Medical Center | Everett | Washington |
United States | Virginia Heart - The Cardiovascular Group, P.C. | Falls Church | Virginia |
United States | Washington Regional Medical Center | Fayetteville | Arkansas |
United States | John Peter Smith Hospital | Fort Worth | Texas |
United States | North Colorado Medical Center | Greeley | Colorado |
United States | Greenville Health System | Greenville | South Carolina |
United States | Vidant Medical Center | Greenville | North Carolina |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Pinnacle Health System | Harrisburg | Pennsylvania |
United States | Hartford Hospital | Hartford | Connecticut |
United States | Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | Memorial Regional Hospital | Hollywood | Florida |
United States | Cardiovascular Institute of the South | Houma | Louisiana |
United States | CHI St. Luke's Health Baylor College of Medicine Med. Ctr. | Houston | Texas |
United States | Memorial Hermann Hospital | Houston | Texas |
United States | Park Plaza Hospital | Houston | Texas |
United States | The Methodist Hospital | Houston | Texas |
United States | St. Vincent Hospital | Indianapolis | Indiana |
United States | First Coast Cardiovascular Institute | Jacksonville | Florida |
United States | Memorial Hospital Jacksonville | Jacksonville | Florida |
United States | Kansas University Medical Center | Kansas City | Kansas |
United States | St. Luke's Hospital | Kansas City | Missouri |
United States | Tennova Healthcare - Turkey Creek Medical Center | Knoxville | Tennessee |
United States | Scripps Health | La Jolla | California |
United States | University of California at San Diego (UCSD) Medical Center | La Jolla | California |
United States | Lancaster General Hospital | Lancaster | Pennsylvania |
United States | Sparrow Clinical Research Institute | Lansing | Michigan |
United States | BryanLGH Heart Institute | Lincoln | Nebraska |
United States | Arkansas Heart Hospital | Little Rock | Arkansas |
United States | Baptist Health Medical Center | Little Rock | Arkansas |
United States | South Denver Cardiology Associates PC | Littleton | Colorado |
United States | Saint Barnabas Medical Center | Livingston | New Jersey |
United States | Ronald Reagan UCLA Medical Center | Los Angeles | California |
United States | USC University Hospital | Los Angeles | California |
United States | Catholic Medical Center | Manchester | New Hampshire |
United States | WellStar Kennestone Hospital | Marietta | Georgia |
United States | Methodist University Hospital | Memphis | Tennessee |
United States | Heart Center of Lake County | Merrillville | Indiana |
United States | Mercy Hospital | Miami | Florida |
United States | MidMichigan Medical Center-Midland | Midland | Michigan |
United States | Aurora Medical Group | Milwaukee | Wisconsin |
United States | Minneapolis Heart Institute | Minneapolis | Minnesota |
United States | University of Minnesota Medical Center Fairview | Minneapolis | Minnesota |
United States | Midwest Cardiovascular Institute | Naperville | Illinois |
United States | St Thomas Hospital | Nashville | Tennessee |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Yale New Haven Hospital | New Haven | Connecticut |
United States | Louisiana State University Health Sciences Center | New Orleans | Louisiana |
United States | Ochsner Medical Center | New Orleans | Louisiana |
United States | Mount Sinai Hospital | New York | New York |
United States | New York University Hospital | New York | New York |
United States | New York-Presbyterian/Columbia University | New York | New York |
United States | Sentara Norfolk General Hospital | Norfolk | Virginia |
United States | North Kansas City Hospital | North Kansas City | Missouri |
United States | Advocate Health and Hospitals Corporation | Oakbrook Terrace | Illinois |
United States | Integris Baptist Medical Center | Oklahoma City | Oklahoma |
United States | Oklahoma Heart Hospital South | Oklahoma City | Oklahoma |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Advent Health Orlando | Orlando | Florida |
United States | Orlando Regional Medical Center | Orlando | Florida |
United States | Albert Einstein Medical Center | Philadelphia | Pennsylvania |
United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Arizona Cardiovascular Research Center | Phoenix | Arizona |
United States | Banner-University Medical Center Phoenix | Phoenix | Arizona |
United States | Phoenix Cardiovascular Research Group | Phoenix | Arizona |
United States | Allegheny General Hospital - ASRI | Pittsburgh | Pennsylvania |
United States | Providence Heart and Vascular | Portland | Oregon |
United States | Hudson Valley Cardiovascular Practice, P.C. | Poughkeepsie | New York |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | NC Heart and Vascular Research | Raleigh | North Carolina |
United States | WakeMed Hospital | Raleigh | North Carolina |
United States | Eisenhower Medical Center | Rancho Mirage | California |
United States | Renown Regional Medical Center | Reno | Nevada |
United States | Bon Secours Heart & Vascular Institute | Richmond | Virginia |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Rochester General Hospital | Rochester | New York |
United States | St. Francis Hospital | Roslyn | New York |
United States | Mercy Medical Group - Cardiology | Sacramento | California |
United States | Sutter Medical Center, Sacramento | Sacramento | California |
United States | St. Cloud Hospital | Saint Cloud | Minnesota |
United States | Mercy Hospital St. Louis | Saint Louis | Missouri |
United States | Methodist Healthcare System of San Antonio | San Antonio | Texas |
United States | San Diego Cardiac Center | San Diego | California |
United States | California Pacific Medical Center - Van Ness Campus | San Francisco | California |
United States | Swedish Medical Center - Heart & Vascular | Seattle | Washington |
United States | University of Washington Medical Center | Seattle | Washington |
United States | Advanced Cardiovascular Specialists | Shreveport | Louisiana |
United States | Sanford USD Medical Center | Sioux Falls | South Dakota |
United States | Providence Hospital | Southfield | Michigan |
United States | Tampa General Hospital | Tampa | Florida |
United States | University of Arizona | Tucson | Arizona |
United States | Oklahoma Heart Institute at Utica | Tulsa | Oklahoma |
United States | Ventura Cardiology Consultants | Ventura | California |
United States | Lourdes Cardiology Services | Voorhees | New Jersey |
United States | George Washington University Hospital | Washington | District of Columbia |
United States | Waukesha Memorial Hospital | Waukesha | Wisconsin |
United States | Aspirus Wausau Hospital | Wausau | Wisconsin |
United States | Iowa Heart Center | West Des Moines | Iowa |
United States | The Reading Hospital and Medical Center | West Reading | Pennsylvania |
United States | Cardiovascular Research Institute of Kansas | Wichita | Kansas |
United States | Winchester Medical Center | Winchester | Virginia |
United States | University of Massachusetts | Worcester | Massachusetts |
United States | Main Line Health Center/Lankenau Hospital | Wynnewood | Pennsylvania |
United States | St. Elizabeth Health Center | Youngstown | Ohio |
Lead Sponsor | Collaborator |
---|---|
Abbott Medical Devices |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | (Randomized Arm) Cardiovascular mortality | The number of deaths with cardiovascular cause | 12 months post-implantation | |
Other | (Randomized Arm) All-cause hospitalizations | The number of hospitalizations of any cause | 12 months post-implantation | |
Other | (Randomized Arm) Frequency of subject PA pressure uploads | The frequency of subject uploads of PA pressure | 12 months post-implantation | |
Other | (Randomized Arm) Frequency of clinician review of subject PA pressure uploads | The frequency of clinician review of subject uploads of PA pressure | 12 months post-implantation | |
Other | (Randomized Arm) HF medication changes | The number of changes in HF medications | 12 months post-implantation | |
Other | (Randomized Arm) PA pressure measurements | PA pressure measurements | Baseline through 12 months post-implantation | |
Other | (Randomized Arm) NT-proBNP (or BNP) | NT-proBNP (or BNP) measurements | Baseline, 6, and 12 months post-implantation | |
Other | (Randomized Arm) HFHs post- vs. pre-implantation | The number of HFHs at 12 months post-implantation compared to the num ber of HFHs in the 12 months prior to implantation | 12 months post-implantation | |
Other | (Single Arm) EQ-5D-5L | Health status as assessed by the EQ-5D-5L Questionnaire | Baseline, 6, and 12 months post-implantation | |
Other | (Single Arm) KCCQ-12 | Health status as assessed by the KCCQ-12 | Baseline, 6, and 12 months post-implantation | |
Other | (Single Arm) 6MHW Test | 6MHW Test Distance | Baseline, 6, and 12 months post-implantation | |
Other | (Single Arm) Cardiovascular mortality | The number of deaths of cardiovascular cause | 12 months post-implantation | |
Other | (Single Arm) All-cause hospitalizations | The number of hospitalizations of any cause | 12 months post-implantation | |
Other | (Single Arm) Frequency of subject PA pressure uploads | The frequency of subject uploads of PA pressure | 12 months post-implantation | |
Other | (Single Arm) Frequency of clinician review of subject PA pressure uploads | The frequency of clinician review of subject uploads of PA pressure | 12 months post-implantation | |
Other | (Single Arm) HF medication changes | The number of changes in HF medications | 12 months post-implantation | |
Other | (Single Arm) PA pressure measurements | PA pressure measurements | Baseline through 12 months post-implantation | |
Other | (Single Arm) NT-proBNP (or BNP) | NT-proBNP (or BNP) measurements | Baseline, 6, and 12 months post-implantation | |
Primary | (Randomized Arm) Composite outcome of (1) HFHs, (2) intravenous diuretic visits, and (3) all-cause mortality | The composite of:
The number of recurrent HFHs The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy The number of deaths of any cause added together with equal weighting into a total number of events |
12 months post-implantation | |
Primary | (Single Arm) Composite outcome of (1) HFHs, (2) intravenous diuretic visits, and (3) all-cause mortality | The composite outcome of:
The number of recurrent HFHs The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy The number of deaths of any cause added together with equal weighting into a total number of events |
12 months post-implantation | |
Secondary | (Randomized Arm) Composite outcome of (1) HFHs and (2) intravenous diuretic visits | The composite outcome of:
The number of recurrent HFHs The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy added together with equal weighting into a total number of events |
12 months post-implantation | |
Secondary | (Randomized Arm) EQ-5D-5L | Health status as assessed by the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Questionnaire | Baseline, 6, and 12 months post-implantation | |
Secondary | (Randomized Arm) KCCQ-12 | Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) | Baseline, 6, and 12 months post-implantation | |
Secondary | (Randomized Arm) 6MHW Test | Six Minute Hall Walk (6MHW) Test Distance | Baseline, 6, and 12 months post-implantation | |
Secondary | (Randomized Arm) HFHs | The number of recurrent HFHs | 12 months post-implantation | |
Secondary | (Randomized Arm) Intravenous diuretic visits | The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy | 12 months post-implantation | |
Secondary | (Randomized Arm) All-cause mortality | The number of deaths of any cause | 12 months post-implantation | |
Secondary | (Randomized Arm) Safety: Freedom from DSRCs | Freedom from device/system related complications (DSRCs) | 12 months post-implantation | |
Secondary | (Single Arm) Composite outcome of (1) HFHs and (2) intravenous diuretic visits | The composite outcome of:
The number of recurrent HFHs The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy added together with equal weighting into a total number of events |
12 months post-implantation | |
Secondary | (Single Arm) HFHs post- vs. pre-implantation | The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation | 12 months post-implantation | |
Secondary | (Single Arm) HFHs | The number of HFHs | 12 months post-implantation | |
Secondary | (Single Arm) Intravenous diuretic visits | The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy | 12 months post-implantation | |
Secondary | (Single Arm) All-cause mortality | The number of deaths of any cause | 12 months post-implantation | |
Secondary | (Single Arm) Safety: Freedom from DSRCs | Freedom from DSRCs | 12 months post-implantation |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Active, not recruiting |
NCT05896904 -
Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction
|
N/A | |
Completed |
NCT05077293 -
Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
|
||
Recruiting |
NCT05631275 -
The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
|
||
Enrolling by invitation |
NCT05564572 -
Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology
|
N/A | |
Enrolling by invitation |
NCT05009706 -
Self-care in Older Frail Persons With Heart Failure Intervention
|
N/A | |
Recruiting |
NCT04177199 -
What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
|
||
Terminated |
NCT03615469 -
Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)
|
N/A | |
Recruiting |
NCT06340048 -
Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure
|
Phase 1/Phase 2 | |
Recruiting |
NCT05679713 -
Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
|
||
Completed |
NCT04254328 -
The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure
|
N/A | |
Completed |
NCT03549169 -
Decision Making for the Management the Symptoms in Adults of Heart Failure
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Enrolling by invitation |
NCT05538611 -
Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
|
||
Recruiting |
NCT04262830 -
Cancer Therapy Effects on the Heart
|
||
Completed |
NCT06026683 -
Conduction System Stimulation to Avoid Left Ventricle Dysfunction
|
N/A | |
Withdrawn |
NCT03091998 -
Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support
|
Phase 1 | |
Recruiting |
NCT05564689 -
Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy
|