Evidence map›Paper›PMID 40634236›Full record

ArticleESC heart failure2025

Two-year outcomes of a cardiac microcurrent device in chronic heart failure: A first-in-human pilot study.

Dragana B Kosevic, Una Radak, Petar Vukovic, Jan D Schmitto, Kersten Brandes, Peter Goettel, Hans-Dirk Duengen, Elvis Tahirovic, Marija Zdravkovic, Johannes Mueller and 5 more

Abstract read
In one paragraph

Article in ESC heart failure, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Article
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

15 authors.

Dragana B KosevicCardiovascular Institute Dedinje, Belgrade, Serbia.
Una RadakCardiovascular Institute Dedinje, Belgrade, Serbia.
Petar VukovicCardiovascular Institute Dedinje, Belgrade, Serbia.
Jan D SchmittoHannover Medical School, Hannover, Germany.
Kersten BrandesBerlin Heals, Berlin, Germany.
Peter GoettelBerlin Heals, Berlin, Germany.
Hans-Dirk DuengenCharité-Universitätsmedizin Berlin, Berlin, Germany.
Elvis TahirovicSciRent Clinical Research and Science, Belgrade, Serbia.
Marija ZdravkovicUniversity Hospital Medical Center Bezanijska Kosa, Belgrade, Serbia.
Johannes MuellerBerlin Heals, Berlin, Germany.
Faouzi KallelBerlin Heals, Berlin, Germany.
Marat FudimDuke University, Durham, North Carolina, USA.
Stefan D AnkerDeutsches Herzzentrum der Charité, Campus Virchow Klinikum, Berlin, Germany, Institute of Health Centre for Regenerative Therapies (BCRT), German Centre for Cardiovascular Research (DZHK) partner site Berlin, Charité Universitätsmedizin, Berlin, Germany.
Jesus Eduardo RameThomas Jefferson University, Advanced Cardiac and Pulmonary Vascular Disease Programs, Toll Heart and Vascular Institute, Philadelphia, Pennsylvania, USA.
Miodrag PericCardiovascular Institute Dedinje, Belgrade, Serbia.

Funding

Berlin Heals
6 · The paper itself

Abstract

aimsIn heart failure patients, altered myocardial electrical fields linked to oedema may impair left ventricular function. While short-term use of implanted microcurrent generators (C-MIC) has shown promise, long-term effects remain unclear. This study assessed the safety and efficacy of C-MIC use beyond the initial 6 month pilot period.

methodsPatients from the initial C-MIC pilot study who were alive at 6 months were screened for 2 year follow-up. The primary endpoint included rates of all-cause, cardiac- and device-related mortality, all-cause, cardiac and device related hospitalizations, along with adverse events, device malfunctions and exchanges. Secondary endpoints evaluated device performance via left ventricular ejection fraction (LVEF), 6 min walk distance, New York Heart Association (NYHA) class and SF-36 quality-of-life scores and the need for prolonged therapy.

resultsOf the 10 patients enrolled in the initial study, 7 were enrolled in follow-up (mean age 52.4 ± 7.6 years, NYHA Class III and mean LVEF 31.7 ± 3.7%). No device-related adverse events occurred. One non-cardiac, non-device related death was reported at 18 months. Improvement in LVEF of 11.60% [95% confidence interval (CI): 5.64-17.56, P < 0.001] from baseline to 6 months was maintained at 2 years post-C-MIC deactivation, with a sustained increase of 12.56% from baseline (95% CI: 4.67-20.45, P = 0.002). Similarly, the 6 min walk distance improved by 206.35 m at 6 months (95% CI: 161.32-251.39, P < 0.0001) and remained at 191 m above baseline at 2 years (95% CI: 131.83-250.99, P < 0.0001). Improvements in NYHA functional class and SF-36 quality-of-life scores observed at 6 months were also preserved throughout the 2 year follow-up. One patient required C-MIC reactivation.

conclusionsLong-term use of the C-MIC device appears safe with sustained improvements in NYHA class, LVEF, 6 min walk distance and quality of life, supporting the long-term therapeutic potential of microcurrent therapy.

Indexed as

Electric Stimulation TherapyHeart FailureQuality of LifeStroke VolumeVentricular Function, LeftChronic DiseaseEquipment DesignFemaleFollow-Up StudiesHumansMaleMiddle AgedPilot ProjectsTime FactorsTreatment Outcomecardiac fibroblastcardiovascular diseasefibrosismicrocurrentmyofibroblasts

Identifiers

PMID40634236
PMCPMC12450836

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.