CCM in Heart Failure With Preserved Ejection Fraction (CCM-HFpEF)
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|ClinicalTrials.gov Identifier: NCT03240237|
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : July 28, 2020
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|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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)|
|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|
Experimental: CCM therapy
Device: Optimizer SMART
Cardiac Contractility Modulation
- KCCQ change [ Time Frame: 24 weeks ]Mean change from baseline to 24 weeks in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score
- Echocardiography [ Time Frame: 24 weeks ]LAVi and diastolic function: septal E' velocity, septal E/E' ratio
- NT-proBNP [ Time Frame: 24 weeks ]Mean Change in 24 weeks
- NYHA class [ Time Frame: 24 weeks ]Mean Change in 24 weeks
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
|Contact: Leah A Reddig||+49 711 220 456-0 ext +firstname.lastname@example.org|
|Principal Investigator:||Carsten Tschoepe, Prof.||University Hospital Charite Berlin|