CCM in Heart Failure With Preserved Ejection Fraction

NCT03240237 | Completed

• 1 other identifier: ID_CP_OPT2016-012_0
• Study Type: interventional
• Target: 47
• Locations: 8 countries
• Sites: 17

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.

Conditions

Heart Failure, Diastolic

Keywords

HFpEF

Outcome Measures

Primary Outcomes (1)

• KCCQ change

  Mean change from baseline to 24 weeks in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score

  24 weeks

Secondary Outcomes (3)

• Echocardiography

  24 weeks

• NT-proBNP

  24 weeks

• NYHA class

  24 weeks

Study Arms (1)

CCM therapy

EXPERIMENTAL

Optimizer SMART

Device: Optimizer SMART

Interventions

Optimizer SMART DEVICE

Cardiac Contractility Modulation

CCM therapy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Baseline ejection fraction ≥ 50% (as assessed by echocardiogram within 30 days of enrollment and confirmed by the echo core laboratory).
• 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)
• Stable optimal medical therapy for Heart failure for 3 months.
• NT-proBNP \> 220 pg/ml for subjects in sinus rhythm or \> 600 pg/ml for subjects in atrial fibrillation
• 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
• Patient giving informed consent, willing to be available for scheduled study follow-up visits, and able to complete all testing of the study protocol

You may not qualify if:

• Age below 40 or greater than 80
• Patients with expected lifespan of less than 12 months from time of enrollment
• Subjects referred to an institution based on a judicial or administrative order
• Dilated left ventricle, as evidenced by LVEDVI \>= 97 mL/m2 (as assessed by the echo core lab)
• Primary cardiac valvular disease (anything more than grade 2)
• Congenital or untreated ischemic heart disease
• 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
• Unstable or frequent (\>1 episode/week) angina pectoris
• Hospitalization for HF requiring the use of inotropic support or IABP within 30 days of enrollment
• Systolic Blood Pressure \> 160 mmHg
• Uncorrected severe anemia (e.g. hemoglobin \<9g/dL)
• PR interval greater than 375 ms
• Exercise tolerance limited due to noncardiac disorders (e.g. deconditioning, severe lung disease, frailty)
• 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
• Myocardial infarction within 90 days of enrollment

Sponsors & Collaborators

• Impulse Dynamics: lead

Study Sites (17)

Friendly Society Private Hospital

Bundaberg, Queensland, 4670, Australia

Location

St. John of God Bunbury

Bunbury, 6150, Australia

Location

St. John of God Murdoch Hospital

Perth, 6000, Australia

Location

Hospital Na Homolce

Prague, 15030, Czechia

Location

Kerckhoff-Klinik GmbH

Bad Nauheim, Hesse, 61231, Germany

Location

INRCA IRCCS Ancona

Ancona, Rome, Italy

Location

Auxologico Institute

Milan, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

Location

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego zakład leczniczy Centralnego Szpitala Klinicznego

Warsaw, 02-097, Poland

Location

Uniwersytecki Szpital Kliniczny we Wrocław

Wroclaw, 50-556, Poland

Location

4 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ we Wroclawiu

Wroclaw, 50-981, Poland

Location

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

Lisbon, Portugal

Location

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, 15706, Spain

Location

Hospital General de Alicante

Alicante, 3010, Spain

Location

Hospital Universitario 12 de Octubre Unidad de Insuficiencia Cardiaca y Trasplante Servicio de Cardiología, Planta 6. Bloque D.Ciber 8

Madrid, 28041, Spain

Location

Hospital Alvaro Cunquero

Vigo, 36312, Spain

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Related Publications (2)

• 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.

  PMID: 26638055 BACKGROUND

• 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.

  PMID: 35855646 RESULT

MeSH Terms

Conditions

Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Carsten Tschoepe, Prof.

  University Hospital Charite Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 7, 2017
• Study Start: May 1, 2018
• Primary Completion: July 25, 2023
• Study Completion: July 25, 2023
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

IT (3); ES (4); SE (1); AU (3); PT (1); DE (1); CZ (1); PL (3)