Evidence map›Paper›PMID 40660878›Full record

Trial reportEuropean journal of heart failure2025

Cardio-microcurrent device treatment for heart failure with reduced ejection fraction: Results from the C-MIC II open-label randomized controlled trial.

Jesus E Rame, Jan D Schmitto, Dragana N Kosevic, Tamara Kovacevic-Preradovic, Sasko Jovev, Marija Zdravkovic, Nermir Granov, Tanja Popov, Igor Rudez, Petar Vukovic and 15 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in European journal of heart failure, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04662034 (Prospective, Randomized, Open, Comparison Study to Demonstrate the Performance and the Safety of Cardiac Microcurrent Therapy), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04662034 nacompletednot on this map

Prospective, Randomized, Open, Comparison Study to Demonstrate the Performance and the Safety of Cardiac Microcurrent Therapy (C-MIC) System

TypeinterventionalSponsorBerlin Heals GmbHRan2021 to 2024Enrolled70ConditionsSystolic Left Ventricular DysfunctionArmsCMIC, Standard of Care (SOC)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

Jesus E Rame *Bruce and Robbi Toll Heart and Vascular Institute, Thomas Jefferson University, Philadelphia, PA, USA.
Jan D Schmitto *Department of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany.
Dragana N Kosevic *Cardiovascular Institute Dedinje, Belgrade, Serbia.
Tamara Kovacevic-PreradovicFaculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina.
Sasko JovevUniversity Clinic of Cardiology, Skopje, North Macedonia.
Marija ZdravkovicUniversity Hospital Medical Center Bezanijska Kosa, Belgrade, Serbia.
Nermir GranovClinical Center, University of Sarajevo, Sarajevo, Bosnia and Herzegovina.
Tanja PopovInstitute of Cardiovascular Diseases of Vojvodina, Vojvodina, Serbia.
Igor RudezUniversity Hospital Dubrava, Zagreb, Croatia.
Petar VukovicMedical School, University Belgrade, Belgrade, Serbia.
Velibor RisticCardiovascular Institute Dedinje, Belgrade, Serbia.
Petr NeuzilCardiology Clinic, Medical Faculty of Charles University and Homolka Hospital Prague, Prague, Czech Republic.
Annette HoltdirkRQM+, Frankfurt, Germany.
Arjang RuhparwarDepartment of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany.
Muhammad Shahzeb KhanBaylor Scott and White Health-Heart Hospital Plano and Baylor Scott and White Research Institute, Dallas, TX, USA.
Hans-Dirk DüngenSCIRENT LLC, Berlin, Germany.
Kersten BrandesBerlin Heals GmbH, Berlin, Germany.
Peter GoettelBerlin Heals GmbH, Berlin, Germany.
Johannes MuellerBerlin Heals GmbH, Berlin, Germany.
Faouzi KallelBerlin Heals GmbH, Berlin, Germany.
Tim FriedeDepartment of Medical Statistics, University Medical Center Göttingen, and DZHK (German Center for Cardiovascular Research), Partner Site Lower Saxony, Göttingen, Germany.
Miodrag PericCardiovascular Institute Dedinje, Belgrade, Serbia.
Marat FudimDuke University, Durham, NC, USA.
Stefan D AnkerDepartment of Cardiology (CVK) of German Heart Center Charité; German Centre for Cardiovascular Research (DZHK) Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany.
C‐MIC II Trial Investigators

Funding

Berlin Heals GmbH
6 · The paper itself

Abstract

aimsIn patients with heart failure, alterations in electrical fields generated within the myocardium have been associated with myocardial oedema which can act as a substrate for left ventricular dysfunction. Safety and efficacy of a direct microcurrent therapy using an implanted generator (C-MIC) remain uncertain. METHODS AND

resultsAmbulatory patients with non-ischaemic dilated cardiomyopathy with left ventricular ejection fraction (LVEF) of 25% to 35% and New York Heart Association (NYHA) class III-IV were randomized to C-MIC (device) or control group in addition to guideline-directed medical therapy. The primary endpoint was change in LVEF at 6 months. Pre-specified secondary endpoints included 6-min walk distance (6MWD), Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS), and NYHA functional class. Of 70 patients randomized, 65 were included in modified intention-to-treat analysis (C-MIC device: n = 32; control: n = 33). At 6 months, treatment with C-MIC versus control improved LVEF (mean difference: 5.1%; 95% confidence interval [CI] 3.1-7.1%, p < 0.001). The proportions of patients with improvement in at least one NYHA class (risk difference: 68.9%; 95% CI 50.6-87.2, p < 0.001), an increase of ≥5 points in KCCQ-OSS (risk difference: 60.0%; 95% CI 42.3-77.6, p < 0.001), and an increase of ≥30% in 6MWD (risk difference: 38.3%; 95% CI 14.4-62.2) were substantially higher in the device versus control group (p < 0.002).

conclusionsIn patients with non-ischaemic chronic heart failure with reduced ejection fraction, the C-MIC device compared with control improved LVEF, symptoms, functional capacity and quality of life.

Indexed as

Cardiomyopathy, DilatedElectric Stimulation TherapyHeart FailureStroke VolumeAgedFemaleHumansMaleMiddle AgedQuality of LifeTreatment OutcomeVentricular Function, LeftWalk TestCardio‐microcurrent deviceElectrical microcurrentHeart failure

Identifiers

PMID40660878
PMCPMC12575409

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.