Evidence map›Paper›PMID 33248462›Full record

Trial reportCardiovascular diabetology2020

Cardiac resynchronization therapy and its effects in patients with type 2 DIAbetes mellitus OPTimized in automatic vs. echo guided approach. Data from the DIA-OPTA investigators.

Celestino Sardu, Pasquale Paolisso, Valentino Ducceschi, Matteo Santamaria, Cosimo Sacra, Massimo Massetti, Antonio Ruocco, Raffaele Marfella

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cardiovascular diabetology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04547244 (Optimization of Cardiac Resynchronization Therapy and Its Effects in Patients With Type 2 Diabetes Mellitus), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
1.6field-weighted citation impact, top 14% of its field
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.

NCT04547244 completednot on this map

Optimization of Cardiac Resynchronization Therapy and Its Effects in Patients With Type 2 Diabetes Mellitus: Automatic Optimization vs. Echocardiographic Guided Optimization.

TypeobservationalSponsorUniversity of Campania Luigi VanvitelliRan2015 to 2020Enrolled200ConditionsHeart Failure, Heart Failure With Reduced Ejection Fraction, Cardiac DeathArmsechocardiographic optimization of CRTd
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Observational
  4. Article
  5. Article
  6. Article
  7. Article
  8. 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

8 authors at 4 institutions in 2 countries.

Celestino SarduDepartment of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli", Piazza Miraglia 2, 80131, Naples, Italy. drsarducele@gmail.com.ORCID 0000-0001-5099-3790
Pasquale PaolissoUnit of Cardiology, Department of Experimental, Diagnostic and Specialty Medicine-DIMES, University of Bologna, Bologna, Italy.
Valentino DucceschiUnit of Cardiovascular Diseases and Arrhythmias, "Vecchio Pellegrini" Hospital, Naples, Italy.
Matteo SantamariaUnit of Cardiovascular Diseases and Arrhythmias, "Gemelli Molise", Campobasso, Italy.
Cosimo SacraUnit of Cardiovascular Diseases and Arrhythmias, "Gemelli Molise", Campobasso, Italy.
Massimo MassettiUnit of Cardiovascular Diseases and Arrhythmias, "Gemelli Molise", Campobasso, Italy.
Antonio RuoccoUnit of Cardiovascular Diseases and Arrhythmias, "Antonio Cardarelli" Hospital, Naples, Italy.
Raffaele MarfellaDepartment of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli", Piazza Miraglia 2, 80131, Naples, Italy.
University of Molise · ITUniversity of Campania "Luigi Vanvitelli" · ITOspedale dei Pellegrini · ITUniversity of Bologna · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the effects of cardiac resynchronization therapy (CRTd) in patients with type 2 diabetes mellitus (T2DM) optimized via automatic vs. echocardiography-guided approach.

backgroundThe suboptimal atrio-ventricular (AV) and inter-ventricular (VV) delays optimization reduces CRTd response. Therefore, we hypothesized that automatic CRTd optimization might improve clinical outcomes in T2DM patients.

methodsWe designed a prospective, multicenter study to recruit, from October 2016 to June 2019, 191 consecutive failing heart patients with T2DM, and candidate to receive a CRTd. Study outcomes were CRTd responders rate, hospitalizations for heart failure (HF) worsening, cardiac deaths and all cause of deaths in T2DM patients treated with CRTd and randomly optimized via automatic (n 93) vs. echocardiography-guided (n 98) approach at 12 months of follow-up.

resultsWe had a significant difference in the rate of CRTd responders (68 (73.1%) vs. 58 (59.2%), p 0.038), and hospitalizations for HF worsening (12 (16.1%) vs. 22 (22.4%), p 0.030) in automatic vs. echocardiography-guided group of patients. At multivariate Cox regression analysis, the automatic guided approach (3.636 [1.271-10.399], CI 95%, p 0.016) and baseline highest values of atrium pressure (automatic SonR values, 2.863 [1.537-6.231], CI 95%, p 0.006) predicted rate of CRTd responders. In automatic group, we had significant difference in SonR values comparing the rate of CRTd responders vs. non responders (1.24 ± 0.72 g vs. 0.58 ± 0.46 g (follow-up), p 0.001), the rate of hospitalizations for HF worsening events (0.48 ± 0.29 g vs. 1.18 ± 0.43 g, p 0.001), and the rate of cardiac deaths ( 1.13 ± 0.72 g vs. 0.65 ± 0.69 g, p 0.047).

conclusionsAutomatic optimization increased CRTd responders rate, and reduced hospitalizations for HF worsening. Intriguingly, automatic CRTd and highest baseline values of SonR could be predictive of CRTd responders. Notably, there was a significant difference in SonR values for CRTd responders vs. non responders, and about hospitalizations for HF worsening and cardiac deaths. Clinical trial ClinicalTrials.gov Identifier NCT04547244.

Indexed as

Cardiac Resynchronization TherapyCardiac Resynchronization Therapy DevicesDiabetes Mellitus, Type 2Echocardiography, DopplerRemote Sensing TechnologyAgedClinical Decision-MakingFemaleHeart FailureHumansItalyMaleMiddle AgedPredictive Value of TestsProspective StudiesRisk AssessmentAutomatic CRTd optimizationCardiac resynchronization therapyType 2 diabetes mellitus

Identifiers

PMID33248462
PMCPMC7700711
OpenAlexW3107928709

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

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 Socratic graph.