Evidence map›Paper›PMID 27920083›Full record

Trial reportBMJ open2016

Nocturnal antihypertensive treatment in patients with type 1 diabetes with autonomic neuropathy and non-dipping: a randomised, placebo-controlled, double-blind cross-over trial.

Henrik Øder Hjortkjær, Tonny Jensen, Klaus F Kofoed, Ulrik M Mogensen, Per Ejlstrup Sigvardsen, Lars Køber, Karen Lisa Hilsted, Helle Corinth, Simone Theilade, Jannik Hilsted

Open access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.8field-weighted citation impact, top 13% 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

9 citing papers in PubMed, 24 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
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  6. Article
  7. Review
  8. Review
  9. Chronotherapy for Hypertension.Current hypertension reports · 2018
    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

10 authors at 3 institutions in 1 country.

Henrik Øder HjortkjærDepartment of Endocrinology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Tonny JensenDepartment of Endocrinology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Klaus F KofoedDepartment of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Ulrik M MogensenDepartment of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Per Ejlstrup SigvardsenDepartment of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Lars KøberDepartment of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Karen Lisa HilstedDepartment of Endocrinology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Helle CorinthDepartment of Endocrinology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Simone TheiladeSteno Diabetes Center, Gentofte, Denmark.
Jannik HilstedDepartment of Endocrinology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Rigshospitalet · DKUniversity of Copenhagen · DKSteno Diabetes Center · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesCardiovascular autonomic neuropathy (CAN) and abnormal circadian blood pressure (BP) rhythm are independent cardiovascular risk factors in patients with diabetes and associations between CAN, non-dipping of nocturnal BP and coronary artery disease have been demonstrated. We aimed to test if bedtime dosing (BD) versus morning dosing (MD) of the ACE inhibitor enalapril would affect the 24-hour BP profile in patients with type 1 diabetes (T1D), CAN and non-dipping.

settingSecondary healthcare unit in Copenhagen, Denmark.

participants24 normoalbuminuric patients with T1D with CAN and non-dipping were included, consisting of mixed gender and Caucasian origin. Mean±SD age, glycosylated haemoglobin and diabetes duration were 60±7 years, 7.9±0.7% (62±7 mmol/mol) and 36±11 years.

interventionsIn this randomised, placebo-controlled, double-blind cross-over study, the patients were treated for 12 weeks with either MD (20 mg enalapril in the morning and placebo at bedtime) or BD (placebo in the morning and 20 mg enalapril at bedtime), followed by 12 weeks of switched treatment regimen. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome was altered dipping of nocturnal BP. Secondary outcomes included a measurable effect on other cardiovascular risk factors than BP, including left ventricular function (LVF).

resultsSystolic BP dipping increased 2.4% (0.03-4.9%; p=0.048) with BD compared to MD of enalapril. There was no increase in mean arterial pressure dipping (2.2% (-0.1% to 4.5%; p=0.07)). No difference was found on measures of LVF (p≥0.15). No adverse events were registered during the study.

conclusionsWe demonstrated that patients with T1D with CAN and non-dipping can be treated with an ACE inhibitor at night as BD as opposed to MD increased BP dipping, thereby diminishing the abnormal BP profile. The potentially beneficial effect on long-term cardiovascular risk remains to be determined. TRIAL REGISTRATION NUMBER: EudraCT2012-002136-90; Post-results.

Indexed as

AgedAngiotensin-Converting Enzyme InhibitorsAntihypertensive AgentsAutonomic Nervous SystemAutonomic Nervous System DiseasesBlood PressureBlood Pressure Monitoring, AmbulatoryCardiovascular DiseasesCircadian RhythmCross-Over StudiesDiabetes Mellitus, Type 1Double-Blind MethodDrug Administration ScheduleEnalaprilFemaleHumansAngiotensin-Converting Enzyme InhibitorsAntihypertensive AgentsEnalapril

Identifiers

PMID27920083
PMCPMC5168694
OpenAlexW2560171660

What OpenQuestion holds

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LicenceCC BY-NC
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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.