CCM in Heart Failure With Preserved Ejection Fraction

NCT ID: NCT03240237

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2023-07-25

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.

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).

Conditions

Heart Failure, Diastolic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

CCM therapy

Optimizer SMART

Group Type: EXPERIMENTAL

Optimizer SMART

Intervention Type: DEVICE

Cardiac Contractility Modulation

Interventions

Optimizer SMART

Cardiac Contractility Modulation

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Impulse Dynamics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carsten Tschoepe, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Charite Berlin

Locations

Friendly Society Private Hospital

Bundaberg, Queensland, Australia

St. John of God Bunbury

Bunbury, , Australia

St. John of God Murdoch Hospital

Perth, , Australia

Hospital Na Homolce

Prague, , Czechia

Kerckhoff-Klinik GmbH

Bad Nauheim, Hesse, Germany

INRCA IRCCS Ancona

Ancona, Rome, Italy

Auxologico Institute

Milan, , Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, , Italy

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego zakład leczniczy Centralnego Szpitala Klinicznego

Warsaw, , Poland

Uniwersytecki Szpital Kliniczny we Wrocław

Wroclaw, , Poland

4 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ we Wroclawiu

Wroclaw, , Poland

West Lisbon Hospital Center, E.P.E., hereinafter referred to as CHLO, E.P.E

Lisbon, , Portugal

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 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

Hospital Alvaro Cunquero

Vigo, , Spain

Karolinska University Hospital

Stockholm, , Sweden

Countries

Australia; Czechia; Germany; Italy; Poland; Portugal; Spain; Sweden

References

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.

Reference Type: BACKGROUND

PMID: 26638055 (View on PubMed)

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):2275-2284. doi: 10.1002/ejhf.2619. Epub 2022 Aug 11.

Reference Type: RESULT

PMID: 35855646 (View on PubMed)

Other Identifiers

ID_CP_OPT2016-012_0

Identifier Type: -

Identifier Source: org_study_id