Cardiac Contractility Modulation (CCM) Therapy in Subjects With Medically Refractory Heart Failure

NCT02857309 | Terminated

• 1 other identifier: ID_CP_OPT2013-026
• Study Type: interventional
• Target: 50
• Locations: 4 countries
• Sites: 8

Brief Summary

The study is designed to substantiate the efficacy of Cardiac Contractility Modulation (CCM) in the heart failure population with ejection fraction ranging between 25 and 45%. The study is designed in an adaptive manner to ensure proper statistical significance and power of the primary efficacy evaluation.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Comparison between the groups of the change in Peak VO2 from baseline to 24 weeks of follow-up.

  from baseline to 24 weeks of follow-up

Secondary Outcomes (3)

• Comparison of change in quality of life as measure (MLWHFQ), from baseline to 24 weeks of follow-up

  from baseline to 24 weeks of follow-up

• Comparison of change in NYHA class, from baseline to 24 weeks of follow-up

  from baseline to 24 weeks of follow-up

• Comparison of change in Peak VO2 from baseline to 24 weeks of follow-up for each of the following subgroups separately: Baseline EF <35% , baseline EF ≥35%

  from baseline to 24 weeks of follow-up

Other Outcomes (6)

• Comparison between the groups of the change in SHFM survival prediction model score from baseline to 24 weeks of follow-up

  from baseline to 24 weeks of follow-up

• Comparison between the groups of the change in MAGGIC survival prediction model score from baseline to 24 weeks of follow-up

  from baseline to 24 weeks of follow-up

• All-cause mortality

  from baseline to 24 weeks of follow-up

Study Arms (2)

Device implant

OTHER

Patients randomized to the treatment group will receive optimal medical therapy for heart failure. and implantation of the OPTIMIZER System.

Device: OPTIMIZER; Drug: Optimal medical therapy

Optimal medical therapy

ACTIVE COMPARATOR

Patients randomized to the control group will receive optimal medical therapy for heart failure.

Drug: Optimal medical therapy

Interventions

OPTIMIZER DEVICE

The OPTIMIZER System delivers non-excitatory cardiac contractility modulation (CCM) signals to the heart that are intended to influence myocardial properties in patients with chronic heart failure. The system has no pacemaker or implantable cardioverter-defibrillator (ICD) functions.

Device implant

Optimal medical therapy DRUG

OMT using standard heart failure (HF) drugs

Also known as: angiotensin receptor blockers, mineralocorticoid receptor antagonists, angiotensin receptor neprilysin inhibitors

Device implant; Optimal medical therapy

Eligibility Criteria

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

You may qualify if:

• Baseline ejection fraction ≥ 25% and ≤45% (as assessed by the site)
• NYHA class II or III (chronic, not transient, heart failure) despite receiving optimal medical therapy for heart failure
• Stable medication for heart failure for at least 30 days based on patient's medical records
• Baseline Peak VO2 ≥ 10 and ≤ 18.5 ml O2/Kg/min (as assessed by the site)

You may not qualify if:

• Potentially correctible cause of HF (valvular, congenital, or untreated ischemic heart disease)
• Clinically significant angina pectoris
• Hospitalization for HF requiring the use of inotropic support or IV diuretics within 30 days of enrollment
• PR interval greater than 375 ms
• Permanent or persistent atrial fibrillation/flutter or cardioversion within 30 days of enrollment.
• Exercise tolerance limited by condition other than heart failure (e.g., angina, chronic obstructive pulmonary disease (COPD), peripheral vascular disease, orthopedic or rheumatologic conditions) or unable to perform baseline stress testing
• Scheduled for a coronary artery bypass graft (CABG) or a percutaneous transluminal coronary angioplasty (PTCA) procedure, or CABG procedure within 90 days or a PTCA procedure within 30 days of enrollment.
• Biventricular pacing system, or indication for Biventricular pacing system
• Myocardial infarction within 90 days of enrollment.
• Mechanical tricuspid or aortic valves.
• Ventricular assist device
• Prior heart transplant
• Pregnant or planning to become pregnant during the study
• Age below 18
• Subject participating in another study, unrelated to CCM, at the same time (or within 30 days prior to enrollment to this study)

Sponsors & Collaborators

• Impulse Dynamics: lead

Study Sites (8)

Universitätsklinik Innere Medizin

Graz, Austria

Location

Universtitätsklinikum; Medizinische Klinik I

Aachen, Germany

Location

Universitätsklinikum; Kardiologie im Herzzentrum

Cologne, Germany

Location

Helios Klinikum; 3. Medizinische Klinik

Erfurt, Germany

Location

Albertinen Krankenhaus

Hamburg, Germany

Location

Universität Leipzig; Abteilung für Kardiologie und Angiologie

Leipzig, Germany

Location

4th Military Hospital

Wroclaw, Poland

Location

Karolinska University Hospital

Stockholm, Sweden

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Angiotensin Receptor Antagonists; Mineralocorticoid Receptor Antagonists

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Diuretics, Potassium Sparing; Diuretics; Natriuretic Agents

Study Officials

• Gerhard Hindricks, Prof.

  Herzzentrum Leipzig GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: August 5, 2016
• Study Start: February 1, 2014
• Primary Completion: February 15, 2018
• Study Completion: February 15, 2018
• Last Updated: September 2, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5); AU (1); SE (1); PL (1)