Evidence map›Paper›PMID 32019575›Full record

ArticleTrials2020

Prevention of doxorubicin-induced Cardiotoxicity by pharmacological non-hypoxic myocardial preconditioning based on Docosahexaenoic Acid (DHA) and carvedilol direct antioxidant effects: study protocol for a pilot, randomized, double-blind, controlled trial (CarDHA trial).

Rodrigo Carrasco, María Cristina Ramirez, Kjersti Nes, Andrés Schuster, Rubén Aguayo, Marcelo Morales, Cristobal Ramos, Daniel Hasson, Camilo G Sotomayor, Pablo Henriquez and 4 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 12% 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.

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

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

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  16. African Vegetables (Oxidative medicine and cellular longevity · 2020
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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

14 authors at 4 institutions in 2 countries.

Rodrigo CarrascoCardiology Department, Clinica Alemana de Santiago, Santiago, Chile.
María Cristina RamirezCardiology Department, Hospital San Juan de Dios, Santiago, Chile.
Kjersti NesCardiology Department, Hospital San Juan de Dios, Santiago, Chile.
Andrés SchusterCardiology Department, Clinica Alemana de Santiago, Santiago, Chile.
Rubén AguayoCardiology Department, Hospital San Juan de Dios, Santiago, Chile.
Marcelo MoralesCardiology Department, Clinica Alemana de Santiago, Santiago, Chile.
Cristobal RamosRadiology Department, Clinica Alemana de Santiago, Santiago, Chile.
Daniel HassonRadiology Department, Clinica Alemana de Santiago, Santiago, Chile.
Camilo G SotomayorDepartment of Internal Medicine, University Medical Center Groningen, Groningen, The Netherlands.
Pablo HenriquezCardiology Department, Hospital San Juan de Dios, Santiago, Chile.
Ignacio CortésCardiology Department, Hospital San Juan de Dios, Santiago, Chile.
Marcia ErazoPublich Health Institute, Faculty of Medicine, University of Chile, Santiago, Chile.
Claudio SalasMedical Oncology Department, Clinica Alemana de Santiago, Vitacura 5951, Santiago, Chile.
Juan G GormazMedical Oncology Department, Clinica Alemana de Santiago, Vitacura 5951, Santiago, Chile. jgormaz@gmail.cl.ORCID http://orcid.org/0000-0003-3424-4807
Clínica Alemana · CLHospital San Juan de Dios · CLInstituto de Salud Pública de Chile · CLUniversity Medical Center Groningen · NL

Funding

Fondo de Fomento al Desarrollo Científico y Tecnológico 11150999
6 · The paper itself

Abstract

backgroundAnthracycline-induced cardiotoxicity (AIC), a condition associated with multiple mechanisms of damage, including oxidative stress, has been associated with poor clinical outcomes. Carvedilol, a β-blocker with unique antioxidant properties, emerged as a strategy to prevent AIC, but recent trials question its effectiveness. Some evidence suggests that the antioxidant, not the β-blocker effect, could prevent related cardiotoxicity. However, carvedilol's antioxidant effects are probably not enough to prevent cardiotoxicity manifestations in certain cases. We hypothesize that breast cancer patients taking carvedilol as well as a non-hypoxic myocardial preconditioning based on docosahexaenoic acid (DHA), an enhancer of cardiac endogenous antioxidant capacity, will develop less subclinical cardiotoxicity manifestations than patients randomized to double placebo. METHODS/

designWe designed a pilot, randomized controlled, two-arm clinical trial with 32 patients to evaluate the effects of non-hypoxic cardiac preconditioning (DHA) plus carvedilol on subclinical cardiotoxicity in breast cancer patients undergoing anthracycline treatment. The trial includes four co-primary endpoints: changes in left ventricular ejection fraction (LVEF) determined by cardiac magnetic resonance (CMR); changes in global longitudinal strain (GLS) determined by two-dimensional echocardiography (ECHO); elevation in serum biomarkers (hs-cTnT and NT-ProBNP); and one electrocardiographic variable (QTc interval). Secondary endpoints include other imaging, biomarkers and the occurrence of major adverse cardiac events during follow-up. The enrollment and follow-up for clinical outcomes is ongoing. DISCUSSION: We expect a group of anthracycline-treated breast cancer patients exposed to carvedilol and non-hypoxic myocardial preconditioning with DHA to show less subclinical cardiotoxicity manifestations than a comparable group exposed to placebo.

trial registrationISRCTN registry, ID: ISRCTN69560410. Registered on 8 June 2016.

Indexed as

AdolescentAdrenergic beta-AntagonistsAdultAgedAntibiotics, AntineoplasticAntioxidantsBiomarkersBreast NeoplasmsCardiotoxicityCarvedilolDocosahexaenoic AcidsDouble-Blind MethodDoxorubicinFemaleFollow-Up StudiesHumansAdrenergic beta-AntagonistsAntibiotics, AntineoplasticAntioxidantsBiomarkersCarvedilolDocosahexaenoic AcidsDoxorubicinAnthracyclinesCarDHACarvedilolChemotherapy-induced cardiotoxicityDHAStudy protocol

Identifiers

PMID32019575
PMCPMC7001267
OpenAlexW3004804646

What OpenQuestion holds

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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.