Anti-hypertensive Medication Dosing Regimen in Effective Blood Pressure Control

Hypertension Clinical Trial

— HARMONY  

Official title:

Hellenic Anglo Research Into Morning Or Evening Antihypertensive Drug deliverY Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01669928
• Other study ID #: CRO1749
• Status: Completed
• Phase: Phase 4
• Start date: April 2012
• Est. completion date: July 2015

Study information

• Verified date: March 2021
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomised crossover trial of anti-hypertensive medication dosing regimen in effective blood pressure control. To investigate whether there is a difference in 24 hour blood pressure (BP) control when antihypertensive medications are taken in the morning compared with the evening.

Description:

The identification of any significant difference could lead to more effective therapeutic management of arterial hypertension, which in turn would result in a reduced cardiovascular burden, lower costs and a better quality of life for hypertensive patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Caucasian patients aged 18-80 years;
• History of any grade of hypertension for at least 1 year, including at least 3 months of constant antihypertensive medication (consisting of = 1 antihypertensive drugs, each administered in one dose daily), with reasonably controlled BP (=150/90 mmHg and = 115/75 mmHg on usual medication) based on previous clinic records, in the last 3 months.

Exclusion Criteria:

• BP levels > 150/90 mmHg or < 115/75 mmHg in the last 3 months.
• Postural hypotension, defined as symptoms resulting from a > 20 mm Hg drop of systolic BP or a > 10 mm Hg drop of diastolic BP or both between 1 and 3 min after standing from the sitting position.
• Known Extreme dippers at baseline (fall of mean night time SBP > 20% of mean day time SBP)
• Individuals with jobs which require night-time shift work.
• Pregnant women or those planning to become pregnant.

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Anti-hypertensive Medication -
Patients will be taking their routine blood pressure lowering medication prescribed by their GP, different patients will be using different blood pressure lowering medication. Dosing regimen either in the morning (between 06.00 and 11.00) or in the evening (between 18.00 and 23.00).

Locations

Country	Name	City	State
Greece	Aristotle University of Thessaloniki	Thessaloniki
United Kingdom	Imperial Clinical Trials Unit	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Aristotle University Of Thessaloniki

Countries where clinical trial is conducted

Greece,  United Kingdom, 

References & Publications (7)

Bruguerolle B. Chronopharmacokinetics. Current status. Clin Pharmacokinet. 1998 Aug;35(2):83-94. Review. — View Citation

Heart Outcomes Prevention Evaluation Study Investigators, Yusuf S, Sleight P, Pogue J, Bosch J, Davies R, Dagenais G. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. N Engl J Med. 2000 Jan 20;342(3):145-53. Erratum in: 2000 May 4;342(18):1376. N Engl J Med 2000 Mar 9;342(10):748. — View Citation

Hermida RC, Ayala DE, Mojón A, Fernández JR. Influence of circadian time of hypertension treatment on cardiovascular risk: results of the MAPEC study. Chronobiol Int. 2010 Sep;27(8):1629-51. doi: 10.3109/07420528.2010.510230. — View Citation

Lemmer B. Clinical chronopharmacology: the importance of time in drug treatment. Ciba Found Symp. 1995;183:235-47; discussion 247-53. Review. — View Citation

Mayet J, Chapman N, Li CK, Shahi M, Poulter NR, Sever PS, Foale RA, Thom SA. Ethnic differences in the hypertensive heart and 24-hour blood pressure profile. Hypertension. 1998 May;31(5):1190-4. — View Citation

Rothwell PM, Howard SC, Dolan E, O'Brien E, Dobson JE, Dahlöf B, Sever PS, Poulter NR. Prognostic significance of visit-to-visit variability, maximum systolic blood pressure, and episodic hypertension. Lancet. 2010 Mar 13;375(9718):895-905. doi: 10.1016/S0140-6736(10)60308-X. — View Citation

Smolensky MH, Hermida RC, Ayala DE, Tiseo R, Portaluppi F. Administration-time-dependent effects of blood pressure-lowering medications: basis for the chronotherapy of hypertension. Blood Press Monit. 2010 Aug;15(4):173-80. doi: 10.1097/MBP.0b013e32833c7308. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in 24 Hour Systolic Blood Pressure	Changes in 24 hour systolic Blood Pressure using ABPM	6 months
Secondary	Mean Day-time ABPM Systolic BP		6 months
Secondary	Mean Day-time ABPM Diastolic BP		6 months
Secondary	?ean Night Time ABPM Systolic BP		6 months
Secondary	?ean Night Time ABPM Diastolic BP		6 months
Secondary	Mean Clinic - Systolic BP	This measure was assessed at a clinic.	6 months
Secondary	Mean Clinic - Diastolic BP	This measure was assessed at a clinic.	6 months
Secondary	Self Reported Side Effects	Serious Adverse Events reported during the trial	12 months
Secondary	Quality of Life Score	Quality of Life Score via questionnaire - EQ-5D-5L Score scale is 0-100, 100 optimal health state.	6 months