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New treatment option for Heart Failure
Official title Assessment of CCM in HF With Higher Ejection Fraction
ClinicalTrials.gov ID: NCT05064709
What this study is testing
- What it's testing
- 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%.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed and dated informed consent form;
- Male or non-pregnant female, 18 years or older;
- Diagnosed with symptomatic heart failure;
- LVEF ≥40 and ≤70% (as assessed by site echo);
- A. Heart failure hospitalization within 12 months prior to study consent OR an urgent heart failure visit requiring IV therapy within 6 months prior...
You likely can't join if
- Resting ventricular rate \ 110 bpm;
- Resting systolic blood pressure \<100 or ≥160 mmHg;
- BMI greater than 46
- Any severe valvular stenotic disease or any severe valvular regurgitation;
- Mechanical tricuspid valve;
- Complex congenital heart disease;
See the full eligibility criteria
- Signed and dated informed consent form;
- Male or non-pregnant female, 18 years or older;
- Diagnosed with symptomatic heart failure;
- LVEF ≥40 and ≤70% (as assessed by site echo);
- 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...
- people must meet one of the following conditions:
- 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.
- 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...
- Resting ventricular rate \ 110 bpm;
- Resting systolic blood pressure \<100 or ≥160 mmHg;
- BMI greater than 46
- Any severe valvular stenotic disease or any severe valvular regurgitation;
- Mechanical tricuspid valve;
- Complex congenital heart disease;
- 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;
- Unable to walk at least 100 meters or walks more than 450 meters during a 6MWT;
- A KCCQ CCS score higher than 85;
- Hypertrophic, infiltrative/restrictive or inflammatory cardiomyopathy;
- Unstable angina pectoris within 30 days prior to study consent;
- Acute, decompensated heart failure requiring IV therapy or ultrafiltration within 30 days prior to consent, in the hospital or an outpatient setting;
- Receiving cardiac resynchronization therapy (CRT); NOTE: people with active/ongoing cardiac resynchronization therapy (CRT) implanted more than one year ago are eligible for inclusion if they are currently classified as...
- 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;
- Myocardial infarction within 90 days prior to study consent;
- Prior heart transplant or ventricular assist device;
- Planning to become pregnant during the study;
- Dialysis (permanent) or GFR \<15 ml/min/1.73m2;
- Participating in another investigational drug or device study that may interfere with the interpretation of study data;
- 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;
- Expected lifespan of less than 18 months from time of study consent;
- Unable to follow through study protocol for any reasons in the investigator's judgement.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Mesa, Arizona, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Tuscon, Arizona, United States
- Concord, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Northridge, California, United States
- Redwood City, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Danbury, Connecticut, United States
- Hartford, Connecticut, United States
- Atlantis, Florida, United States
- Cutler Bay, Florida, United States
- Fort Lauderdale, Florida, United States
- Hollywood, Florida, United States
- Miami, Florida, United States
- Naples, Florida, United States
+ 62 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Mesa, Arizona, United States; Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Tuscon, Arizona, United States; Concord, California, United States and 76 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.