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CCM in Heart Failure With Preserved Ejection Fraction (CCM-HFpEF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03240237
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Impulse Dynamics

Brief Summary:

This pilot study will evaluate the efficacy and safety of CCM therapy in heart failure patients with baseline EF≥50% (HFpEF) who have New York Heart Association (NYHA) Class II or III symptoms despite appropriate medication.

The terminology of the HF classification HFpEF is based on the 2016 European Society of Cardiology (ESC) Heart Failure Guidelines.


Condition or disease Intervention/treatment Phase
Heart Failure, Diastolic Device: Optimizer SMART Not Applicable

Detailed Description:

This is a pilot clinical study of CCM in addition to optimal medical therapy (OMT) over a 24 week period.The primary endpoint shall be mean change from baseline to 24 weeks in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score (reflecting integrated information on physical limitations, symptoms, self-efficacy, social interference and quality of life).

This pilot study will collect efficacy and safety data in heart failure patients having NYHA class II and III symptoms despite appropriate medication with baseline ejection fraction equal or greater than 50% (HFpEF populations).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This pilot study is designed and powered for evaluating the efficacy and safety of CCM therapy in heart failure patients with baseline EF≥50% (HFpEF) who have NYHA Class II or III symptoms despite appropriate medication, for potential expansion of the CE Mark indication for use in the HFpEF population.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Cardiac Contractility Modulation Therapy in Subjects With Heart Failure With Preserved Ejection Fraction
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: CCM therapy
Optimizer SMART
Device: Optimizer SMART
Cardiac Contractility Modulation




Primary Outcome Measures :
  1. KCCQ change [ Time Frame: 24 weeks ]
    Mean change from baseline to 24 weeks in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score


Secondary Outcome Measures :
  1. Echocardiography [ Time Frame: 24 weeks ]
    LAVi and diastolic function: septal E' velocity, septal E/E' ratio

  2. NT-proBNP [ Time Frame: 24 weeks ]
    Mean Change in 24 weeks

  3. NYHA class [ Time Frame: 24 weeks ]
    Mean Change in 24 weeks



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. Inclusion criteria

    1. Baseline ejection fraction ≥ 50% (as assessed by echocardiogram within 30 days of enrollment and confirmed by the echo core laboratory).
    2. NYHA class II or III symptoms despite receiving stable optimal medical therapy (OMT) for at least 30 days based on patient's medical records (chronic stable, not transient or crescendo heart failure or angina pectoris)
    3. Stable optimal medical therapy for Heart failure for 3 months.
    4. NT-proBNP > 220 pg/ml for subjects in sinus rhythm or > 600 pg/ml for subjects in atrial fibrillation
    5. Has the following (as assessed by the core lab):

      • LAVi ≥ 34 ml/m² or LVH >12mm AND either
      • E/e' ≥ 13 OR
      • septal e' < 7 cm/s or lateral e' <10 cm/s
    6. Patient giving informed consent, willing to be available for scheduled study follow-up visits, and able to complete all testing of the study protocol
  2. Exclusion criteria

    1. Age below 40 or greater than 80
    2. Patients with expected lifespan of less than 12 months from time of enrollment
    3. Subjects referred to an institution based on a judicial or administrative order
    4. Dilated left ventricle, as evidenced by LVEDVI >= 97 mL/m2 (as assessed by the echo core lab)
    5. Primary cardiac valvular disease (anything more than grade 2)
    6. Congenital or untreated ischemic heart disease
    7. Infiltrative / inflammatory / genetic cardiomyopathy as documented in the medical record (e.g. amyloid, hemochromatosis, myocarditis, hypertrophic cardiomyopathy, M. Fabry, cardiac tumor), or persistent large pericardial effusion
    8. Unstable or frequent (>1 episode/week) angina pectoris
    9. Hospitalization for HF requiring the use of inotropic support or IABP within 30 days of enrollment
    10. Systolic Blood Pressure > 160 mmHg
    11. Uncorrected severe anemia (e.g. hemoglobin <9g/dL)
    12. PR interval greater than 375 ms
    13. Exercise tolerance limited due to noncardiac disorders (e.g. deconditioning, severe lung disease, frailty)
    14. Scheduled for a cardiac surgery or a PCI procedure, or had a cardiac surgery procedure within 90 days or a PCI procedure within 30 days prior to enrollment
    15. Myocardial infarction within 90 days of enrollment
    16. Cardioversion within 30 days of enrollment
    17. History of significant ectopy either on 12-lead ECG or Holter monitoring (more than 10% PVCs).
    18. Heart rate > 110 bpm on ECG for patients with atrial fibrillation
    19. Mechanical tricuspid valve
    20. Prior heart transplant or ventricular assist device
    21. Pregnant or planning to become pregnant during the study
    22. Breastfeeding subjects
    23. Subject participating in another medical therapy or device related study, unrelated to CCM™, at the same time or within 30 days prior to enrollment into this study
    24. Subjects on dialysis, or with documented GFR<30 or with other major medical disorder (e.g. severe anemia, liver failure)
    25. Subjects with any active non-cardiac implants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240237


Contacts
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Contact: Leah A Reddig +49 711 220 456-0 ext +4907112204560 l.reddig@impulse-dynamics.com

Locations
Show Show 25 study locations
Sponsors and Collaborators
Impulse Dynamics
Investigators
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Principal Investigator: Carsten Tschoepe, Prof. University Hospital Charite Berlin
Publications of Results:
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Responsible Party: Impulse Dynamics
ClinicalTrials.gov Identifier: NCT03240237    
Other Study ID Numbers: ID_CP_OPT2016-012_0
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Impulse Dynamics:
HFpEF
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases