Heart Failure, Diastolic Clinical Trial
— CCM-HFpEFOfficial title:
Cardiac Contractility Modulation Therapy in Subjects With Heart Failure With Preserved Ejection Fraction
Verified date | April 2024 |
Source | Impulse Dynamics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 47 |
Est. completion date | July 25, 2023 |
Est. primary completion date | July 25, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Australia | St. John of God Bunbury | Bunbury | |
Australia | Friendly Society Private Hospital | Bundaberg | Queensland |
Australia | St. John of God Murdoch Hospital | Perth | |
Czechia | Hospital Na Homolce | Praha 5 | |
Germany | Kerckhoff-Klinik GmbH | Bad Nauheim | Hesse |
Italy | INRCA IRCCS Ancona | Ancona | Rome |
Italy | Auxologico Institute | Milan | |
Italy | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | |
Poland | Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego zaklad leczniczy Centralnego Szpitala Klinicznego | Warsaw | |
Poland | 4 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ we Wroclawiu | Wroclaw | |
Poland | Uniwersytecki Szpital Kliniczny we Wroclaw | Wroclaw | |
Portugal | West Lisbon Hospital Center, E.P.E., hereinafter referred to as CHLO, E.P.E | Lisbon | |
Spain | Hospital General de Alicante | Alicante | |
Spain | Hospital Universitario 12 de Octubre Unidad de Insuficiencia Cardiaca y Trasplante Servicio de Cardiología, Planta 6. Bloque D.Ciber 8 | Madrid | |
Spain | Santiago de Compostella -- Servicio de Cardiología y UCC/ Cardiology and Coronary Care Department Hospital Clínico Universitario. XXI de Santiago de Compostela SERGAS | Santiago De Compostela | C/ A Choupana S.n |
Spain | Hospital Alvaro Cunquero | Vigo | |
Sweden | Karolinska University Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Impulse Dynamics |
Australia, Czechia, Germany, Italy, Poland, Portugal, Spain, Sweden,
Linde C, Grabowski M, Ponikowski P, Rao I, Stagg A, Tschope C. Cardiac contractility modulation therapy improves health status in patients with heart failure with preserved ejection fraction: a pilot study (CCM-HFpEF). Eur J Heart Fail. 2022 Dec;24(12):22 — View Citation
Tschope C, Van Linthout S, Spillmann F, Klein O, Biewener S, Remppis A, Gutterman D, Linke WA, Pieske B, Hamdani N, Roser M. Cardiac contractility modulation signals improve exercise intolerance and maladaptive regulation of cardiac key proteins for systolic and diastolic function in HFpEF. Int J Cardiol. 2016 Jan 15;203:1061-6. doi: 10.1016/j.ijcard.2015.10.208. Epub 2015 Oct 27. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | KCCQ change | Mean change from baseline to 24 weeks in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score | 24 weeks | |
Secondary | Echocardiography | LAVi and diastolic function: septal E' velocity, septal E/E' ratio | 24 weeks | |
Secondary | NT-proBNP | Mean Change in 24 weeks | 24 weeks | |
Secondary | NYHA class | Mean Change in 24 weeks | 24 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT04573166 -
Personalized Atrial Septostomy for Heart Failure
|
N/A | |
Recruiting |
NCT02425371 -
Optimized Management of Comorbidity in Heart Failure With Preserved Ejection Fraction in the Elderly (>60 Years)
|
Phase 3 | |
Terminated |
NCT03312387 -
Muscle, Essential Amino Acids, and eXercise in Heart Failure
|
N/A | |
Completed |
NCT05475028 -
Network Medicine Approaches to Classify Heart Failure With PReserved Ejection Fraction by Signatures of DNA Methylation and Point-of-carE Risk calculaTors (PRESMET)
|
||
Recruiting |
NCT04950218 -
The Psoriasis Echo Study
|
||
Completed |
NCT02334891 -
Kyoto Congestive Heart Failure Study
|
||
Recruiting |
NCT05577819 -
Prevalence and Prediction of ATTR in Ambulatory Patients With HFpEF
|
N/A | |
Completed |
NCT05139472 -
Impact of Empagliflozin on Functional Capacity in Heart Failure With Preserved Ejection Fraction
|
Phase 3 | |
Recruiting |
NCT04682704 -
The Effect of Different Low-Level Tragus Stimulation Parameters On Autonomic Nervous System Function
|
N/A | |
Completed |
NCT03924479 -
Respiratory Muscle Function in Heart Failure
|
N/A | |
Recruiting |
NCT03830957 -
Efficacy and Safety of Ivabradine to Reduce Heart Rate Prior to Coronary CT-angiography in Advanced Heart Failure: Comparison With β-Blocker
|
N/A | |
Completed |
NCT02589977 -
Myocardial Perfusion, Oxidative Metabolism, and Fibrosis in HFpEF
|
Phase 4 | |
Completed |
NCT02946476 -
Prognostic Impact of Noncardiac Comorbidities in Heart Failure Patients
|
N/A | |
Recruiting |
NCT04179643 -
NAN-101 in Patients With Class III Heart Failure
|
Phase 1 | |
Recruiting |
NCT05425459 -
RESPONDER-HF Trial
|
N/A | |
Completed |
NCT04940312 -
MyoMobile Study: App-based Activity Coaching in Patients With Heart Failure and Preserved Ejection Fraction
|
||
Recruiting |
NCT04602338 -
Diagnosis and OutcoMes evaluAtIoN of Multicenter Patients With HFpEF Using Multimodality Imaging
|
||
Recruiting |
NCT05887271 -
A Randomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction Preserved Ejection Fraction
|
Phase 2/Phase 3 | |
Recruiting |
NCT05479669 -
Value of Intense Phenotyping in Heart Failure With Preserved Ejection Fraction
|
||
Completed |
NCT02408003 -
Changes in Cardiac Deformation Following Physiologic Alterations and Inotropic Support.
|
N/A |