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Heart Failure, DiastolicCCM-HFpEFNCT03240237

CCM in Heart Failure With Preserved Ejection Fraction

A study testing Optimizer SMART in people with Heart Failure, Diastolic, run by Impulse Dynamics at 17 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Heart Failure, Diastolic
What is being tested?
Optimizer SMART
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
17 sitesin 8 countries
Study dates
1 May 2018to 25 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  1. Inclusion criteria
  2. Baseline ejection fraction ≥ 50% (as assessed by echocardiogram within 30 days of enrollment and confirmed by the echo core laboratory).
  3. 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)
  4. Stable optimal medical therapy for Heart failure for 3 months.
  5. NT-proBNP > 220 pg/ml for subjects in sinus rhythm or > 600 pg/ml for subjects in atrial fibrillation
  6. 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
  1. 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
  3. Age below 40 or greater than 80
  4. Patients with expected lifespan of less than 12 months from time of enrollment
  5. Subjects referred to an institution based on a judicial or administrative order
  6. Dilated left ventricle, as evidenced by LVEDVI >= 97 mL/m2 (as assessed by the echo core lab)
  7. Primary cardiac valvular disease (anything more than grade 2)
  8. Congenital or untreated ischemic heart disease
  9. 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
  10. Unstable or frequent (>1 episode/week) angina pectoris
  11. Hospitalization for HF requiring the use of inotropic support or IABP within 30 days of enrollment
  12. Systolic Blood Pressure > 160 mmHg
  13. Uncorrected severe anemia (e.g. hemoglobin <9g/dL)
  14. PR interval greater than 375 ms
  15. Exercise tolerance limited due to noncardiac disorders (e.g. deconditioning, severe lung disease, frailty)
  16. 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
  17. Myocardial infarction within 90 days of enrollment
  18. Cardioversion within 30 days of enrollment
  19. History of significant ectopy either on 12-lead ECG or Holter monitoring (more than 10% PVCs).
  20. Heart rate > 110 bpm on ECG for patients with atrial fibrillation
  21. Mechanical tricuspid valve
  22. Prior heart transplant or ventricular assist device
  23. Pregnant or planning to become pregnant during the study
  24. Breastfeeding subjects
  25. 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
  26. Subjects on dialysis, or with documented GFR<30 or with other major medical disorder (e.g. severe anemia, liver failure)
  27. Subjects with any active non-cardiac implants

Trial locations and contacts

17 sites in 8 countries.

17 sites in 8 countries

Spain4 sites

  • Hospital General de Alicante

    Alicante, 3010

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

    Madrid, 28041

  • 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

  • Hospital Alvaro Cunquero

    Vigo, 36312

Other trials in Spain

Australia3 sites

  • St. John of God Bunbury

    Bunbury, 6150

  • Friendly Society Private Hospital

    Bundaberg, Queensland, 4670

  • St. John of God Murdoch Hospital

    Perth, 6000

Other trials in Australia

Italy3 sites

  • INRCA IRCCS Ancona

    Ancona, Rome

  • Auxologico Institute

    Milan

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, 00168

Other trials in Italy

Poland3 sites

  • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego zakład leczniczy Centralnego Szpitala Klinicznego

    Warsaw, 02-097

  • Uniwersytecki Szpital Kliniczny we Wrocław

    Wroclaw, 50-556

  • 4 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ we Wroclawiu

    Wroclaw, 50-981

Other trials in Poland

Czechia1 site

  • Hospital Na Homolce

    Prague, 15030

Other trials in Czechia

Germany1 site

  • Kerckhoff-Klinik GmbH

    Bad Nauheim, Hesse, 61231

Other trials in Germany

Portugal1 site

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

    Lisbon

Other trials in Portugal

Sweden1 site

  • Karolinska University Hospital

    Stockholm

Other trials in Sweden

About this study

Official title: Cardiac Contractility Modulation Therapy in Subjects With Heart Failure With Preserved Ejection Fraction

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.

Read the 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).

Being tested
Optimizer SMART
Keywords
HFpEF
Medical subject headings
Heart Failure, Diastolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optimizer SMARTDevice

    Cardiac Contractility Modulation

Study groups in NCT03240237
Study groupRoleWhat they receive
CCM therapyExperimentalOptimizer SMART
Receives: Device: Optimizer SMART

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. KCCQ change

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

    Measured: 24 weeks

Secondary outcomes (3)

  1. Echocardiography

    LAVi and diastolic function: septal E' velocity, septal E/E' ratio

    Measured: 24 weeks

  2. NT-proBNP

    Mean Change in 24 weeks

    Measured: 24 weeks

  3. NYHA class

    Mean Change in 24 weeks

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2017
  2. Study start1 May 2018
  3. Primary completion25 Jul 2023
  4. Study completion25 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03240237
Sponsor's protocol ID
ID_CP_OPT2016-012_0
Acronym
CCM-HFpEF
Status last verified
Apr 2024
First submitted
2 Aug 2017
Last updated
23 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 26638055

  • 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.

    PubMed 35855646

Questions about this trial

What is this clinical trial studying?

A study testing Optimizer SMART in people with Heart Failure, Diastolic, run by Impulse Dynamics at 17 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Spain, Australia, Italy, Poland, Czechia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

KCCQ change (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03240237, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.

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