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NYHA Class III Heart FailureFIX-HF-5CNCT01381172

Evaluate Safety and Efficacy of the OPTIMIZER® System in Subjects With Moderate-to-Severe Heart Failure: FIX-HF-5C

A study testing Optimizer System in people with NYHA Class III Heart Failure and NYHA Class IV Heart Failure, run by Impulse Dynamics at 42 sites in 3 countries.

Completed

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

Official record
Search all trials

Trial summary

The objective of this investigation is to evaluate the safety and effectiveness of the OPTIMIZER® System in subjects with medically refractory moderate-to-severe heart failure. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Optimizer System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
42 sitesin 3 countries
Study dates
Jan 2011to 19 Mar 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who are 18 years of age or older
  • Subjects who are either male or female. Females of childbearing potential must be using a medically approved method of birth control and must agree to continue to use birth control throughout the study, or must be surgically sterilized (tubal ligation, hysterectomy) or post-menopausal for at least 1 year.
  • Condition
  • Subjects who have a baseline ejection fraction greater than or equal to 25% and less than or equal to 45% by echocardiography determined by the echocardiography core laboratory.
  • Subjects who have been treated for heart failure for at least 90 days (including treatment with a β-blocker for at least 90 days unless the subject is intolerant) and are in New York Heart Association functional Class III and IV at the time of enrollment.
  • Subjects receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure according to the region- specific guideline recommendations. For patients with EF≤35%, this regimen shall consist of the appropriate doses of diuretics, ACE-inhibitor or angiotensin II receptor blocker and β-blocker. Stable is defined as no more than a 100% increase or 50% decrease in dose.
  • Subjects who, in the opinion of the Principal Investigator (based on the current guidelines for clinical practice ), have a clinical indication for an implanted cardiac defibrillator (ICD, e.g., EF≤35%) and/or pacemaker, must have an existing device or agree to undergo implantation of such a device unless the patient refuses to undergo the implantation of such device for personal reasons.
  • Subjects who are willing and able to return for all follow-up visits.

Who cannot join

  • Subjects whose baseline peak VO2 is <9 or >20 ml O2/min/kg.
  • Subjects who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease.
  • Subjects who have clinically significant angina pectoris, consisting of angina during daily life (i.e., Canadian Cardiovascular Society Angina score of II or more), an episode of unstable angina within 30 days of enrollment, or angina and/or ECG changes during exercise testing performed during baseline evaluation.
  • Subjects who have been hospitalized for heart failure which required the use of inotropic support within 30 days of enrollment.
  • Subjects who have a clinically significant amount of ambient ectopy, defined as more than 8,900 PVCs per 24 hours on baseline Holter monitoring.
  • Subjects having a PR interval greater than 375 ms.
Show all 16Show fewer
  • Subjects who have chronic (permanent or persistent) atrial fibrillation or atrial flutter or those cardioverted within 30 days of enrollment.
  • Subjects whose exercise tolerance is limited by a condition other than heart failure (e.g., angina, COPD, peripheral vascular disease, orthopedic or rheumatologic conditions) or who are unable to perform baseline stress testing.
  • Subjects who are scheduled for a CABG or a PTCA procedure, or who have undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of enrollment.
  • Subjects who have a biventricular pacing system, an accepted indication for such a device, or a QRS width of 130ms or greater.
  • Subjects who have had a myocardial infarction within 90 days of enrollment.
  • Subjects who have mechanical tricuspid valve.
  • Subjects who have a prior heart transplant.
  • Subjects on dialysis.
  • Subjects who are participating in another experimental protocol.
  • Subjects who are unable to provide informed consent.

Trial locations and contacts

42 sites in 3 countries.

42 sites in 3 countries

United States32 sites

  • University of Maryland

    Baltimore, Maryland, 21201

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • St. Elizabeth's Medical Center

    Brighton, Massachusetts, 02135

  • The Lindner Center

    Cincinnati, Ohio, 45219

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Dallas VA Medical Center

    Dallas, Texas, 75216

  • Detroit Medical Center - Cardiovascular Institute

    Detroit, Michigan, 48201

  • Inova Heart & Vascular Institute

    Falls Church, Virginia, 22042

  • Stern Cardiovascular Foundation

    Germantown, Tennessee, 38138

  • Cardiovascular Consultants

    Glendale, Arizona, 85306

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Nebraska Heart Institute

    Lincoln, Nebraska, 68526

  • Bryan Heart LGH

    Lincoln, Nebraska, 69506

  • Cardiovascular Associates of Mesa

    Mesa, Arizona, 85206

  • Chan Heart Rhythm Institute

    Mesa, Arizona, 85206

  • Aurora Health Care

    Milwaukee, Wisconsin, 53215

  • Advocate Medical Group - Midwest Heart Foundation

    Naperville, Illinois, 60540

  • Yale - New Haven Hospital

    New Haven, Connecticut, 06519

  • Ochsner Clinic

    New Orleans, Louisiana, 70121

  • Mt. Sinai Medical Center

    New York, New York, 10029

  • UMDNJ

    Newark, New Jersey, 07103

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

  • Florida Hospital

    Orlando, Florida, 32803

  • Arizona Heart & Rhythm Center

    Phoenix, Arizona, 85013

  • Guthrie Medical Group

    Sayre, Pennsylvania, 18840

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Washington Adventist Hospital

    Takoma Park, Maryland, 20912

  • Florida Hospital - Pepin Heart Institute

    Tampa, Florida, 33613

  • Pima Heart

    Tucson, Arizona, 85712

  • University of Arizona Sarver Heart Center

    Tucson, Arizona, 85724

  • Trinity Clinic

    Tyler, Texas, 75701

Other trials in United States

Germany9 sites

  • Herz- und Gefässzentrum Bad Bevensen

    Bad Bevensen, 29549

  • Charité Berlin - Campus Benjamin Franklin

    Berlin, 12203

  • Charité Campus-Virchow-Klinikum

    Berlin, 13353

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45122

  • ASKLEPIOS Klinik St. Georg

    Hamburg, 20099

  • UKE - Universitäres Herzzentrum GmbH

    Hamburg, 20246

  • Universitätsmedizin Göttingen

    Hanover, Göttingen, 37075

  • Universitätsmedizin Mannheim

    Mannheim, 68167

  • Klinikum der Univ. München - Grosshadern

    München, 81377

Other trials in Germany

Czechia1 site

  • Na Homolce Hospital

    Prague, 15030

Other trials in Czechia

About this study

Official title: Evaluation of the Safety and Efficacy of the OPTIMIZER® System in Subjects With Moderate-to-Severe Heart Failure With Ejection Fraction Between 25% and 45%: FIX-HF-5C

The objective of this investigation is to evaluate the safety and effectiveness of the OPTIMIZER® System in subjects with medically refractory moderate-to-severe heart failure.

Read the detailed description

The Impulse Dynamics FIX-HF-5C Study is a prospective, multicenter, randomized study to evaluate the safety and efficacy of cardiac contractility modulation (CCM) signals delivered by the implantable OPTIMIZER System in patients with NYHA class III and IV heart failure and an ejection fraction 25-45%. The study will involve the recruitment of 160 subjects at a total of up to 60 sites.

Those subjects who fulfill all inclusion and exclusion criteria based upon baseline test results will be randomly assigned in a 1:1 ratio to either the OPTIMIZER System plus optimal medical therapy (OMT) or to a control group receiving OMT alone. All randomized subjects will be followed for 24 weeks and shall receive the same study related assessments throughout the course of the study. In addition, all subjects will continue to receive OMT for the treatment of their heart failure. Mortality will be reported out to 2 years.

Being tested
Optimizer System, No intervention: Optimal medical therapy
Keywords
Heart Failure, Congestive Heart Failure, Chronic heart disease, Cardiac contractility modulation, CCM, CHF
Medical subject headings
Heart Failure

What participants receive

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

  • Optimizer SystemDevice

    Also called CCM therapy

    The OPTIMIZER System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.

  • No intervention: Optimal medical therapyOther

    The control group receives optimal medical therapy only.

Study groups in NCT01381172
Study groupRoleWhat they receive
TreatmentExperimentalThe treatment group receives the OPTIMIZER System implant and continues with optimal heart failure medical therapy.
Receives: Device: Optimizer System
ControlOtherThe Control group will not receive the OPTIMIZER System and will continue with optimal heart failure medical therapy.
Receives: Other: No intervention: Optimal medical therapy

What is being measured

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

  1. Peak VO2

    Exercise tolerance quantified by peak VO2 measured with cardiopulmonary exercise stress testing (CPX) and evaluated by a blinded core lab.

    Measured: 24 weeks

Secondary outcomes (4)

  1. Minnesota Living With Heart Failure (MLWHF) Questionnaire

    Change in quality of life at 24 weeks compared to baseline, as assessed by the Minnesota Living with Heart Failure (MLWHF) Questionnaire. The MLWHFQ score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of lif

    Measured: 24 weeks

  2. Peak VO2 With Respiratory Exchange Ratio (RER)

    Peak VO2 with change in respiratory exchange ratio (RER) included as a covariate, as measured by a blinded core lab.

    Measured: 24 weeks

  3. NYHA

    Heart failure class, as assessed by the New York Heart Association (NYHA) classification.

    Measured: 24 weeks

  4. Peak VO2 With a Peak RER of ≥1.05

    Peak VO2 in an analysis that only includes tests with a peak RER of ≥1.05.

    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 posted27 Jun 2011 (estimated)
  2. Study startJan 2011
  3. Primary completion19 Mar 2019
  4. Study completion19 Mar 2019

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01381172
Sponsor's protocol ID
CP OPT2009-009
Other IDs
G030099
Acronym
FIX-HF-5C
Status last verified
Aug 2021
First submitted
22 Jun 2011
Last updated
17 Sep 2021
Data monitoring committee
Yes

Publications

  • Kadish A, Nademanee K, Volosin K, Krueger S, Neelagaru S, Raval N, Obel O, Weiner S, Wish M, Carson P, Ellenbogen K, Bourge R, Parides M, Chiacchierini RP, Goldsmith R, Goldstein S, Mika Y, Burkhoff D, Abraham WT. A randomized controlled trial evaluating the safety and efficacy of cardiac contractility modulation in advanced heart failure. Am Heart J. 2011 Feb;161(2):329-337.e1-2. doi: 10.1016/j.ahj.2010.10.025.

    PubMed 21315216

  • Abraham WT, Burkhoff D, Nademanee K, Carson P, Bourge R, Ellenbogen KA, Parides M, Kadish A; FIX-HF-5 Investigators and Coordinators. A randomized controlled trial to evaluate the safety and efficacy of cardiac contractility modulation in patients with systolic heart failure: rationale, design, and baseline patient characteristics. Am Heart J. 2008 Oct;156(4):641-648.e1. doi: 10.1016/j.ahj.2008.05.019.

    PubMed 18926146

  • Neelagaru SB, Sanchez JE, Lau SK, Greenberg SM, Raval NY, Worley S, Kalman J, Merliss AD, Krueger S, Wood M, Wish M, Burkhoff D, Nademanee K. Nonexcitatory, cardiac contractility modulation electrical impulses: feasibility study for advanced heart failure in patients with normal QRS duration. Heart Rhythm. 2006 Oct;3(10):1140-7. doi: 10.1016/j.hrthm.2006.06.031. Epub 2006 Jul 8.

    PubMed 17018340

  • Abraham WT, Nademanee K, Volosin K, Krueger S, Neelagaru S, Raval N, Obel O, Weiner S, Wish M, Carson P, Ellenbogen K, Bourge R, Parides M, Chiacchierini RP, Goldsmith R, Goldstein S, Mika Y, Burkhoff D, Kadish A; FIX-HF-5 Investigators and Coordinators. Subgroup analysis of a randomized controlled trial evaluating the safety and efficacy of cardiac contractility modulation in advanced heart failure. J Card Fail. 2011 Sep;17(9):710-7. doi: 10.1016/j.cardfail.2011.05.006. Epub 2011 Jun 22.

    PubMed 21872139

  • Abraham WT, Lindenfeld J, Reddy VY, Hasenfuss G, Kuck KH, Boscardin J, Gibbons R, Burkhoff D; FIX-HF-5C Investigators and Coordinators. A randomized controlled trial to evaluate the safety and efficacy of cardiac contractility modulation in patients with moderately reduced left ventricular ejection fraction and a narrow QRS duration: study rationale and design. J Card Fail. 2015 Jan;21(1):16-23. doi: 10.1016/j.cardfail.2014.09.011. Epub 2014 Oct 5.

    PubMed 25285748

  • Abraham WT, Kuck KH, Goldsmith RL, Lindenfeld J, Reddy VY, Carson PE, Mann DL, Saville B, Parise H, Chan R, Wiegn P, Hastings JL, Kaplan AJ, Edelmann F, Luthje L, Kahwash R, Tomassoni GF, Gutterman DD, Stagg A, Burkhoff D, Hasenfuss G. A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Cardiac Contractility Modulation. JACC Heart Fail. 2018 Oct;6(10):874-883. doi: 10.1016/j.jchf.2018.04.010. Epub 2018 May 10.

    PubMed 29754812

Questions about this trial

What is this clinical trial studying?

A study testing Optimizer System in people with NYHA Class III Heart Failure and NYHA Class IV Heart Failure, run by Impulse Dynamics at 42 sites in 3 countries.

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

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. 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 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Germany, Czechia. 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?

Yes. Results are posted in the registry (first posted 17 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Peak VO2 (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 NCT01381172, which also lists 6 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 17 Sep 2021.

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