RECRUITING

Assessment of CCM in HF With Higher Ejection Fraction

Talk to us

Conditions

Heart FailureHeart Failure With Preserved Ejection FractionHeart Failure With Mid Range Ejection FractionHeart Failure With Moderately Reduced Ejection FractionDiastolic Heart FailureHFpEFCCMCCM therapycardiac contractility modulationsymptomatic heart failureleft ventricular ejection fractionLVEFOptimizerOptimizer Smart MiniQuality of Life

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The AIM HIGHer Clinical Trial will evaluate the safety and efficacy of Cardiac Contractility Modulation (CCM) therapy in patients with heart failure with LVEF ≥40% and ≤70%.

Official Title

Assessment of Implantable CCM in the Heart Failure Group With Higher Ejection Fraction

Quick Facts

Study Start:2022-02-03
Study Completion:2026-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05064709

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Signed and dated informed consent form;
  2. 2. Male or non-pregnant female, 18 years or older;
  3. 3. Diagnosed with symptomatic heart failure;
  4. 4. LVEF ≥40 and ≤70% (as assessed by site echo);
  5. 5. A. Heart failure hospitalization within 12 months prior to study consent OR an urgent heart failure visit requiring IV therapy within 6 months prior to study consent OR B. If there is no heart failure hospitalization within 12 months prior to study consent OR an urgent heart failure visit requiring IV therapy within 6 months prior to study consent, an elevated BMI-adjusted natriuretic peptide value must be achieved (Refer to Table 1 in Section 9.2.6)
  6. 6. Subjects must meet one of the following conditions:
  7. * Have stable, scheduled oral loop diuretic treatment (not just PRN) for a minimum of 30 days before providing study consent unless there is a documented allergy or intolerance.
  8. * Eligibility for enrollment is maintained for patients on an SGLT2 inhibitor without prescribed concurrent standing loop diuretic therapy if investigators provide instructions for a flexible PRN diuretic regimen (deemed appropriate by the clinician in response to symptoms or weight gain) Note: Stable is defined as no more than a 100% increase or 50% decrease in dose within the last 30 days. A one-time hold of diuretic dosing for 24 hours during the 30-day period is allowed and not an exclusionary event.
  1. 1. Resting ventricular rate \<50 or \>110 bpm;
  2. 2. Resting systolic blood pressure \<100 or ≥160 mmHg;
  3. 3. BMI greater than 46
  4. 4. Any severe valvular stenotic disease or any severe valvular regurgitation;
  5. 5. Mechanical tricuspid valve;
  6. 6. Complex congenital heart disease;
  7. 7. Exercise tolerance limited by a condition other than heart failure that, in the opinion of the investigator, contributes significantly to the primary symptoms of shortness of breath and/or exercise intolerance;
  8. 8. Unable to walk at least 100 meters or walks more than 450 meters during a 6MWT;
  9. 9. A KCCQ CCS score higher than 85;
  10. 10. Hypertrophic, infiltrative/restrictive or inflammatory cardiomyopathy;
  11. 11. Unstable angina pectoris within 30 days prior to study consent;
  12. 12. Acute, decompensated heart failure requiring IV therapy or ultrafiltration within 30 days prior to consent, in the hospital or an outpatient setting;
  13. 13. Receiving cardiac resynchronization therapy (CRT); NOTE: Subjects with active/ongoing cardiac resynchronization therapy (CRT) implanted more than one year ago are eligible for inclusion if they are currently classified as NYHA class III or higher.
  14. 14. Scheduled for a cardiac surgery or a percutaneous cardiac intervention (PCI) or have undergone cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent;
  15. 15. Myocardial infarction within 90 days prior to study consent;
  16. 16. Prior heart transplant or ventricular assist device;
  17. 17. Planning to become pregnant during the study;
  18. 18. Dialysis (permanent) or GFR \<15 ml/min/1.73m2;
  19. 19. Participating in another investigational drug or device study that may interfere with the interpretation of study data;
  20. 20. Currently undergoing active chemotherapeutic and/or radiation treatment for cancer or has a history of chemotherapy during the 2-year period prior to study consent;
  21. 21. Expected lifespan of less than 18 months from time of study consent;
  22. 22. Unable to follow through study protocol for any reasons in the investigator's judgement.

Contacts and Locations

Study Contact

Maria Fernanda Villarreal, MD
CONTACT
8453592389
aimhigher@impulsedynamics.com

Principal Investigator

Javed Butler, MD, MPH, MBA
PRINCIPAL_INVESTIGATOR
Baylor Scott and White Research Institute, Dallas, Texas
Oussama Wazni, MD, MBA
PRINCIPAL_INVESTIGATOR
Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio, USA

Study Locations (Sites)

Grandview Medical Group Research, LLC
Birmingham, Alabama, 35243
United States
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
CardioVascular Associates of Mesa
Mesa, Arizona, 85206
United States
Chan Heart Rhythm Institute
Mesa, Arizona, 85206
United States
Southwest Cardiovascular Associates
Mesa, Arizona, 85208
United States
Banner Health- Phoenix
Phoenix, Arizona, 85006
United States
Arizona Heart Rhythm
Phoenix, Arizona, 85016
United States
Cardiovascular Consultants, Ltd
Phoenix, Arizona, 85032
United States
HonorHealth
Scottsdale, Arizona, 85258
United States
Pima Heart and Vascular
Tuscon, Arizona, 85712
United States
John Muir Health
Concord, California, 94520
United States
Northbay Heart and Vascular
Fairfield, California, 94533
United States
University of California San Diego
La Jolla, California, 92093
United States
USC Keck School of Medicine
Los Angeles, California, 90033
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
Valley Clinical Trials Pasadena
Northridge, California, 91325
United States
Valley Clinical Trials- Northridge
Northridge, California, 91325
United States
Sequoia Hospital
Redwood City, California, 94062
United States
University of California Davis Health
Sacramento, California, 95817
United States
University of California, San Francisco
San Francisco, California, 94143
United States
Hartford Healthcare
Hartford, Connecticut, 06103
United States
Nuvance Health
Wilton, Connecticut, 06897
United States
HCA Florida JFK Hospital
Atlantis, Florida, 33462
United States
Nouvelle Clinical Research LLC
Cutler Bay, Florida, 33189
United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
United States
Broward Health
Fort Lauderdale, Florida, 33316
United States
Memorial Healthcare System
Hollywood, Florida, 33021
United States
Baptist Health South Florida
Miami, Florida, 33176
United States
NCA Research Institute - Florida
Naples, Florida, 34102
United States
AdventHealth Orlando
Orlando, Florida, 32803
United States
Revival Clinical Research
Orlando, Florida, 32807
United States
Tallahassee Research Institute
Tallahassee, Florida, 32308
United States
Cleveland Clinic Foundation - Florida Weston Hospital
Weston, Florida, 33326
United States
Piedmont Healthcare
Atlanta, Georgia, 30309
United States
WellStar Health System, Inc
Marietta, Georgia, 30062
United States
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237
United States
Ascension Medical Group St. Vincent
Indianapolis, Indiana, 46260
United States
University of Iowa
Iowa City, Iowa, 52242
United States
MercyOne Iowa Heart
West Des Moines, Iowa, 50266
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
Kansas City Cardiac Arrhythmia Research LLC
Overland Park, Kansas, 66211
United States
Baptist Health Lexington
Lexington, Kentucky, 40503
United States
University of Kentucky Research Foundation
Lexington, Kentucky, 40506
United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Ascension St. John
Detroit, Michigan, 48236
United States
Ascension Providence Hospital
Southfield, Michigan, 48075
United States
Trinity health- Michigan Heart
Ypsilanti, Michigan, 48197
United States
Minneapolis Heart Institute at Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
United States
North Mississippi Medical Center
Tupelo, Mississippi, 38801
United States
St. Louis Heart and Vascular
Bridgeton, Missouri, 63044
United States
St. Luke&#39;s Hospital
Chesterfield, Missouri, 63017
United States
St. Lukes Hospital Kansas City (Mid America Heart Institute)
Kansas City, Missouri, 64111
United States
Bryan Heart
Lincoln, Nebraska, 68506
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-5331
United States
Catholic Medical Center
Manchester, New Hampshire, 03102
United States
Our Lady of Lourdes
Camden, New Jersey, 08103
United States
Hackensack University Medical Center
Edison, New Jersey, 08837
United States
Jersey Shore University Medical Center
Edison, New Jersey, 08837
United States
Cooper Hospital- Cardiovascular Associates of Delaware Valley
Haddon Heights, New Jersey, 08035
United States
Atlantic Health System- Morristown Medical Center
Morristown, New Jersey, 07960
United States
Rutgers New Jersey Medical School
Piscataway, New Jersey, 08854
United States
Weill Cornell Medicine
New York, New York, 10021
United States
Sanger Heart and Vascular
Charlotte, North Carolina, 28203
United States
TriHealth Bethesda
Cincinnati, Ohio, 45202
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States
OhioHealth Research Institute
Columbus, Ohio, 43214
United States
Mercy Health- St. Vincent Medical Center LLC
Toledo, Ohio, 43608
United States
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104
United States
St. Francis Hospital - Tulsa
Tulsa, Oklahoma, 74136
United States
Providence Heart & Vascular
Portland, Oregon, 97225
United States
Bryn Mawr Medical Specialists Association
Bryn Mawr, Pennsylvania, 19010
United States
UPMC Pinnacle Harrisburg
Harrisburg, Pennsylvania, 17110
United States
Penn State Hershey Medical City
Hershey, Pennsylvania, 17033
United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104-6061
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
United States
Tower Health Reading Hospital
Reading, Pennsylvania, 19611
United States
WellSpan Health
York, Pennsylvania, 17403
United States
Prisma Health Upstate
Greenville, South Carolina, 29601
United States
The Stern Cardiovascular Foundation
Germantown, Tennessee, 38138
United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
United States
Ascension Seton
Austin, Texas, 78723
United States
Austin Heart
Austin, Texas, 78756
United States
Baylor Scott and White Research Institute
Dallas, Texas, 75204
United States
HCA Medical City Dallas
Dallas, Texas, 75230
United States
Baylor Scott White- All Saints- Fort Worth
Fort Worth, Texas, 76104
United States
Medical City Fort Worth Hospital
Fort Worth, Texas, 76104
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Houston Methodist
Houston, Texas, 77030
United States
Memorial Hermann Texas Medical Center
Houston, Texas, 77030
United States
Heart Rhythm Specialists
McKinney, Texas, 75070
United States
Baylor Scott and White- The Heart Hospital- Plano
Plano, Texas, 75093
United States
Baylor Scott and White Research Institute - Round Rock
Round Rock, Texas, 78665
United States
Methodist Hospital
San Antonio, Texas, 78229
United States
Swedish Medical Center
Seattle, Washington, 98122
United States
Peace Health
Vancouver, Washington, 98664
United States

Collaborators and Investigators

Sponsor: Impulse Dynamics

  • Javed Butler, MD, MPH, MBA, PRINCIPAL_INVESTIGATOR, Baylor Scott and White Research Institute, Dallas, Texas
  • Oussama Wazni, MD, MBA, PRINCIPAL_INVESTIGATOR, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio, USA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-03
Study Completion Date2026-02-01

Study Record Updates

Study Start Date2022-02-03
Study Completion Date2026-02-01

Terms related to this study

Keywords Provided by Researchers

  • HFpEF
  • Heart failure
  • CCM
  • CCM therapy
  • cardiac contractility modulation
  • symptomatic heart failure
  • left ventricular ejection fraction
  • LVEF
  • Optimizer
  • Optimizer Smart Mini
  • Quality of Life

Additional Relevant MeSH Terms

  • Heart Failure
  • Heart Failure With Preserved Ejection Fraction
  • Heart Failure With Mid Range Ejection Fraction
  • Heart Failure With Moderately Reduced Ejection Fraction
  • Diastolic Heart Failure