Evidence map›Paper›PMID 25293387›Full record

Trial reportBMJ open2014

Nocturnal antihypertensive treatment in patients with type 1 diabetes with autonomic neuropathy and non-dipping of blood pressure during night time: protocol for a randomised, placebo-controlled, double-blind, two-way crossover study.

Henrik Hjortkær, Tonny Jensen, Klaus Kofoed, Ulrik Mogensen, Lars Køber, Karen Lisa Hilsted, Helle Corinth, Simone Theilade, Jannik Hilsted

Erratum issuedOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 32% 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

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. Trial
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

Henrik HjortkærDepartment of Endocrinology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Tonny JensenDepartment of Endocrinology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Klaus KofoedDepartment of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Ulrik MogensenDepartment 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

introductionCardiac autonomic neuropathy (CAN) and elevated nocturnal blood pressure are independent risk factors for cardiovascular disease in patients with diabetes. Previously, associations between CAN, non-dipping of nocturnal blood pressure and coronary artery calcification have been demonstrated. The present protocol describes a trial to test the efficacy of bedtime dosing of the ACE inhibitor enalapril on night time blood pressure and left ventricular mass in patients with type 1 diabetes. MATERIALS AND

methodsIn a randomised, double-blind, two-way cross-over study, 24 normoalbuminuric patients with type 1 diabetes with CAN will be treated for 12 weeks with either morning or bedtime dosing of 20 mg enalapril, followed by 12 weeks of switched treatment regimen. During each treatment period, two 24 h ambulatory blood pressure measurements will be performed and after each treatment period left ventricular mass will be determined by multisliced CT. Primary end points will be reduction in blood pressure and reduction in left ventricular mass. ETHICS AND DISSEMINATION: The study has been approved by the Danish Medicines Agency, the Scientific-Ethical Committee of the Capital Region of Denmark and the Danish Data Protection Agency. An external monitoring committee (the Good Clinical Practice Unit at Copenhagen University Hospital) will oversee the study. The results of the study will be presented at national and international scientific meetings and publications will be submitted to peer-reviewed journals. TRIAL REGISTRATION NUMBER: EudraCT (2012- 002136-90).

Indexed as

AdultAgedAntihypertensive AgentsAutonomic Nervous System DiseasesBlood PressureBlood Pressure Monitoring, AmbulatoryCross-Over StudiesDiabetes Mellitus, Type 1Diabetic NeuropathiesDouble-Blind MethodDrug ChronotherapyEnalaprilFemaleHeart VentriclesHumansHypertensionAntihypertensive AgentsEnalapril

Identifiers

PMID25293387
PMCPMC4187995
OpenAlexW2116900698

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.