Evidence map›Paper›PMID 28219917›Full record

Trial reportJournal of the American Heart Association2017

Isosorbide Dinitrate, With or Without Hydralazine, Does Not Reduce Wave Reflections, Left Ventricular Hypertrophy, or Myocardial Fibrosis in Patients With Heart Failure With Preserved Ejection Fraction.

Payman Zamani, Scott Akers, Haideliza Soto-Calderon, Melissa Beraun, Maheswara R Koppula, Swapna Varakantam, Deepa Rawat, Prithvi Shiva-Kumar, Philip G Haines, Jesse Chittams and 4 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the American Heart Association, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01516346 (Effect of Organic Nitrates and Hydralazine on Wave Reflections and Left Ventricular Structure and Function in Heart Failure With Preserved Ejection Fraction), which is not on this map. Cited by 26 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
–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.

NCT01516346 phase2completednot on this map

Effect of Organic Nitrates and Hydralazine on Wave Reflections and Left Ventricular Structure and Function in Heart Failure With Preserved Ejection Fraction

TypeinterventionalSponsorCorporal Michael J. Crescenz VA Medical CenterRan2012 to 2017Enrolled44ConditionsHeart Failure, Congestive Heart FailureArmsIsosorbide Dinitrate, Isosorbide Dinitrate + Hydralazine, Placebo
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
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  7. Review
  8. Article
  9. Drug Therapy for Acute and Chronic Heart Failure with Preserved Ejection Fraction with Hypertension: A State-of-the-Art Review.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2024
    Review
  10. Review
  11. Review
  12. Review
  13. Article
  14. Review
  15. Article
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  17. Review
  18. Comparing cardiovascular magnetic resonance strain software packages by their abilities to discriminate outcomes in patients with heart failure with preserved ejection fraction.Journal of cardiovascular magnetic resonance : official journal of the Society for Cardiovascular Magnetic Resonance · 2021
    Article
  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Payman ZamaniDivision of Cardiovascular Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA.
Scott AkersDepartment of Radiology, Philadelphia Veterans' Affairs Medical Center, Philadelphia, PA.
Haideliza Soto-CalderonDivision of Cardiovascular Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA.
Melissa BeraunDivision of Cardiovascular Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA.
Maheswara R KoppulaDivision of Cardiovascular Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA.
Swapna VarakantamDivision of Cardiovascular Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA.
Deepa RawatDivision of Cardiovascular Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA.
Prithvi Shiva-KumarDivision of Cardiovascular Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA.
Philip G HainesDivision of Cardiovascular Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA.
Jesse ChittamsOffice of Nursing Research, School of Nursing, University of Pennsylvania, Philadelphia, PA.
Raymond R TownsendDivision of Nephrology/Hypertension, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
Walter R WitscheyDepartment of Radiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
Patrick SegersBiofluid, Tissue, and Solid Mechanics for Medical Applications, IBiTech, iMinds Medical IT, Ghent University, Ghent, Belgium.
Julio A ChirinosDivision of Cardiovascular Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA julio.chirinos@uphs.upenn.edu.

Funding

NCATS NIH HHS UL1 TR000003NCRR NIH HHS UL1 RR024134NHLBI NIH HHS K23 HL130551NHLBI NIH HHS R00 HL108157NHLBI NIH HHS R01 HL121510NHLBI NIH HHS R56 HL124073NIA NIH HHS R21 AG043802
6 · The paper itself

Abstract

backgroundWave reflections, which are increased in patients with heart failure with preserved ejection fraction, impair diastolic function and promote pathologic myocardial remodeling. Organic nitrates reduce wave reflections acutely, but whether this is sustained chronically or affected by hydralazine coadministration is unknown. METHODS AND

resultsWe randomized 44 patients with heart failure with preserved ejection fraction in a double-blinded fashion to isosorbide dinitrate (ISDN; n=13), ISDN+hydralazine (ISDN+hydral; n=15), or placebo (n=16) for 6 months. The primary end point was the change in reflection magnitude (RM; assessed with arterial tonometry and Doppler echocardiography). Secondary end points included change in left ventricular mass and fibrosis, measured with cardiac magnetic resonance imaging, and the 6-minute walk distance. ISDN reduced aortic characteristic impedance (mean baseline=0.15 [95% CI, 0.14-0.17], 3 months=0.11 [95% CI, 0.10-0.13], 6 months=0.10 [95% CI, 0.08-0.12] mm Hg/mL per second;

conclusionsISDN, with or without hydralazine, does not exert beneficial effects on RM, left ventricular remodeling, or submaximal exercise and is poorly tolerated. ISDN+hydral appears to have deleterious effects on RM, myocardial remodeling, and submaximal exercise. Our findings do not support the routine use of these vasodilators in patients with heart failure with preserved ejection fraction. CLINICAL

trial registrationURL: www.clinicaltrials.gov. Unique identifier: NCT01516346.

Indexed as

AgedDose-Response Relationship, DrugDouble-Blind MethodDrug Therapy, CombinationEchocardiography, DopplerFemaleFibrosisHeart FailureHeart VentriclesHumansHydralazineHypertrophy, Left VentricularIsosorbide DinitrateMagnetic Resonance Imaging, CineMaleMiddle AgedHydralazineIsosorbide DinitrateVasodilator Agentsheart failurehemodynamicsmagnetic resonance imagingremodeling heart failurevascular biologyvascular stiffnessvasodilators

Identifiers

PMID28219917
PMCPMC5523746

What Socratic holds

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LicenceCC BY-NC-ND
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.