Evidence map›Paper›PMID 19789402›Full record

Trial reportEuropean journal of heart failure2009

A randomized, double-blind, placebo-controlled study to determine the effects of valsartan on exercise time in patients with symptomatic heart failure with preserved ejection fraction.

Hari K Parthasarathy, Burkert Pieske, Marianne Weisskopf, Chris D Andrews, Patrick Brunel, Allan D Struthers, Thomas M MacDonald

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of heart failure, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00171106 (A Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Determine the Effects of Valsartan on Exercise Time in Subjects With Symptomatic Diastolic Heart Failure), which is not on this map. Cited by 22 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 8 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.

NCT00171106 phase4completednot on this map

A Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Determine the Effects of Valsartan on Exercise Time in Subjects With Symptomatic Diastolic Heart Failure

TypeinterventionalSponsorNovartisRan2002 to 2008Enrolled150ConditionsDiastolic Dysfunction, Symptomatic Heart FailureArmsvalsartan
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 8 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Angiotensin receptor blockers for heart failure.The Cochrane database of systematic reviews · 2012
    Pooled it
  9. Review
  10. Review
  11. Review
  12. Review
  13. Article
  14. Article
  15. Article
  16. The year in cardiology: heart failure.European heart journal · 2020
    Article
  17. Heart failure with preserved ejection fraction: an update on pathophysiology, diagnosis, treatment, and prognosis.Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologica · 2020
    Review
  18. Review
  19. The Current Focus of Heart Failure Clinical Trials.Journal of cardiac failure · 2018
    Review
  20. 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

7 authors.

Hari K ParthasarathyDepartment of Cardiology, Papworth Hospital, Cambridge CB23 3RE, UK.
Burkert Pieske
Marianne Weisskopf
Chris D Andrews
Patrick Brunel
Allan D Struthers
Thomas M MacDonald

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo determine whether valsartan improves treadmill exercise time, in patients with symptomatic heart failure with a preserved ejection fraction (HFPEF), compared with placebo. METHODS AND

resultsIn this multicentred, double-blind, 14-week study, patients were randomized to receive valsartan (V) 80 mg or placebo (P) once daily on top of background medications. The dose of valsartan was force-titrated up to 320 mg. A total of 152 patients were randomized (V = 70, P = 82). Most patients had well-controlled hypertension (V = 91.2%, P = 89.0%) (mean baseline systolic BP approximately 130 mmHg) and >50% were receiving an angiotensin-converting enzyme inhibitor and/or beta-blocker (V = 57.4%, P = 54.9%). The mean ejection fraction at baseline was 70.48% in the placebo group (n = 64) and 71.52% in the valsartan group (n = 79). Valsartan had no significant effect on exercise time (primary variable), gas exchange variables, 6 min walk test distance, exertion-related symptoms, brain natriuretic peptide levels, echocardiographic parameters, or quality-of-life scores. Valsartan significantly lowered peak exercise systolic BP (-13.1 mmHg vs. placebo; P < 0.001) and improved ratings of perceived exertion (Borg score) (-0.69 vs. placebo; P = 0.008).

conclusionIn this population, which predominantly included patients with well-controlled hypertension and symptomatic HFPEF, addition of valsartan did not increase exercise time within 14 weeks. However, valsartan 320 mg reduced blood pressure and improved symptoms of perceived exertion (Borg score) during exercise and was generally well-tolerated.

Indexed as

AgedAngiotensin II Type 1 Receptor BlockersDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleExercise ToleranceFemaleFollow-Up StudiesHeart FailureHumansMaleMiddle AgedMultivariate AnalysisRisk AssessmentSeverity of Illness IndexStatistics, NonparametricAngiotensin II Type 1 Receptor BlockersTetrazolesValineValsartan

Identifiers

PMID19789402
PMCPMC2754503

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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 OpenQuestion graph.