Evidence map›Paper›PMID 32073676›Full record

ArticleClinical cardiology2020

Beta-blockers withdrawal in patients with heart failure with preserved ejection fraction and chronotropic incompetence: Effect on functional capacity rationale and study design of a prospective, randomized, controlled trial (The Preserve-HR trial).

Patricia Palau, Julia Seller, Eloy Domínguez, Inés Gómez, José María Ramón, Clara Sastre, Rafael de la Espriella, Enrique Santas, Gema Miñana, Francisco J Chorro and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Clinical cardiology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03871803 (Betablockers Withdrawal in Patients With Heart Failure With Preserved Ejection Fraction and Chronotropic Incompetence), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 9% 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.

NCT03871803 phase4completednot on this map

Betablockers Withdrawal in Patients With Heart Failure With Preserved Ejection Fraction and Chronotropic Incompetence: Effect on Functional Capacity Rationale and Study Design of a Prospective, Randomized, Controlled Trial

TypeinterventionalSponsorFundación para la Investigación del Hospital Clínico de ValenciaRan2018 to 2021Enrolled52ConditionsHeart Failure With Normal Ejection Fraction, Chronotropic IncompetenceArmsControlled withdrawal of beta-blockers, Cardiopulmonary Exercise Testing
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
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  3. Review
  4. Article
  5. Review
  6. Article
  7. New aspects in cardiorenal syndrome and HFpEF.Clinical kidney journal · 2022
    Review
  8. Article
  9. Article
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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

12 authors at 4 institutions in 1 country.

Patricia PalauFISABIO. Universitat Jaume I, Castellón, Spain.
Julia SellerCardiology Department, Hospital de Denia, Alicante, Spain.
Eloy DomínguezFISABIO. Universitat Jaume I, Castellón, Spain.ORCID https://orcid.org/0000-0001-7583-8818
Inés GómezCardiology Department, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, A Coruña, Spain.
José María RamónCIBERCV, Madrid, Spain.
Clara SastreCIBERCV, Madrid, Spain.
Rafael de la EspriellaCIBERCV, Madrid, Spain.
Enrique SantasCIBERCV, Madrid, Spain.
Gema MiñanaCIBERCV, Madrid, Spain.ORCID https://orcid.org/0000-0001-8777-2588
Francisco J ChorroCIBERCV, Madrid, Spain.
José Ramón González-JuanateyCardiology Department, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, A Coruña, Spain.
Julio NúñezCIBERCV, Madrid, Spain.ORCID https://orcid.org/0000-0003-1672-7119
Universitat de València · ESCentro de Investigación en Red en Enfermedades Cardiovasculares · ESUniversitat Jaume I · ESUniversity of Alicante · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe pathophysiology of heart failure with preserved ejection fraction (HFpEF) is complex and multifactorial. Chronotropic incompetence (ChI) has emerged as a crucial pathophysiological mechanism. Beta-blockers, drugs with negative chronotropic effects, are commonly used in HFpEF, although current evidence does not support its routine use in these patients. HYPOTHESIS: We postulate beta-blockers may have deleterious effects in HFpEF and ChI. This work aims to evaluate the short-term effect of beta-blockers withdrawal on functional capacity assessed by the maximal oxygen uptake (peakVO2) in patients with HFpEF and ChI.

methodsThis is a prospective, crossover, randomized (1:1) and multicenter study. After randomization, the clinical and cardiac rhythm will be continuously registered for 30 days. PeakVO2 is assessed by cardiopulmonary exercise testing (CPET) at 15 and 30 days in both groups. Secondary endpoints include quality of life, cognitive, and safety assessment. Patients with stable HFpEF, functional class New York Heart Association (NYHA) II-III, chronic treatment with beta-blockers, and ChI will be enrolled. A sample size estimation [alfa: 0.05, power: 90%, a 20% loss rate, and delta change of mean peakVO2: +1.2 mL/kg/min (SD ± 2.0)] of 52 patients is necessary to test our hypothesis.

resultsPatients started enrolling in October 2018. As January 14th, 2020, 28 patients have been enrolled. It is projected to enroll the last patient at the end of July 2020.

conclusionsOptimizing therapy that improves functional capacity remains an unmeet priority in HFpEF. Deprescribing beta-blockers in patients with HFpEF and ChI seems a plausible intervention to improve functional capacity. This trial is an attempt towards precision medicine in this complex syndrome.

trial registrationClinicalTrials.gov: NCT03871803.

Indexed as

Adrenergic beta-AntagonistsBenzodiazepinesDose-Response Relationship, DrugFemaleHeart FailureHumansMaleMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicResearch DesignStroke VolumeVentricular Function, LeftAdrenergic beta-AntagonistsBenzodiazepineschronotropic incompetenceexercise capacityheart failure with preserved ejection fractionquality of life

Identifiers

PMID32073676
PMCPMC7244302
OpenAlexW3007155467

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.