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

doi:10.1136/bmjopen-2014-006142

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

3 Citations (Scopus)

Abstract

INTRODUCTION: Cardiac 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 METHODS: In 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).

Original language	English
Article number	e006142
Journal	B M J Open
Volume	4
Issue number	10
Pages (from-to)	1-6
Number of pages	6
ISSN	2044-6055
DOIs	https://doi.org/10.1136/bmjopen-2014-006142
Publication status	Published - 2014

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Hjortkær, H., Jensen, T., Kofoed, K., Mogensen, U., Køber, L., Hilsted, K. L., Corinth, H., Theilade, S., & Hilsted, J. (2014). 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. B M J Open, 4(10), 1-6. [e006142]. https://doi.org/10.1136/bmjopen-2014-006142

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. / Hjortkær, Henrik; Jensen, Tonny; Kofoed, Klaus et al.

In: B M J Open, Vol. 4, No. 10, e006142, 2014, p. 1-6.

Research output: Contribution to journal › Journal article › Research › peer-review

Hjortkær, H, Jensen, T, Kofoed, K, Mogensen, U, Køber, L, Hilsted, KL, Corinth, H, Theilade, S & Hilsted, J 2014, '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', B M J Open, vol. 4, no. 10, e006142, pp. 1-6. https://doi.org/10.1136/bmjopen-2014-006142

Hjortkær H, Jensen T, Kofoed K, Mogensen U, Køber L, Hilsted KL et al. 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. B M J Open. 2014;4(10):1-6. e006142. doi: 10.1136/bmjopen-2014-006142

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abstract = "INTRODUCTION: Cardiac 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 METHODS: In 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).",

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T1 - Nocturnal antihypertensive treatment in patients with type 1 diabetes with autonomic neuropathy and non-dipping of blood pressure during night time

T2 - protocol for a randomised, placebo-controlled, double-blind, two-way crossover study

AU - Hjortkær, Henrik

AU - Jensen, Tonny

AU - Kofoed, Klaus

AU - Mogensen, Ulrik

AU - Køber, Lars

AU - Hilsted, Karen Lisa

AU - Corinth, Helle

AU - Theilade, Simone

AU - Hilsted, Jannik

N1 - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

PY - 2014

Y1 - 2014

N2 - INTRODUCTION: Cardiac 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 METHODS: In 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).

AB - INTRODUCTION: Cardiac 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 METHODS: In 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).

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