Hypertension Clinical Trial
Official title:
Chronotherapy in Hypertension - a Study of Blood Pressure Levels Following Intake of Antihypertensive Medication in the Morning or at Bedtime
A randomized clinical trials with cross-over design to evaluate changes in blood pressure, renal function (creatinine, estimated glomerular filtration), LDL and HDL-cholesterol after taking antihypertensive drugs in the morning or at bedtime. Blood pressure will be estimated by ambulatory blood pressure measurements. There will be a shift in time of drug intake after 8 weeks for each participant. Approximately 100 individuals aged 40-75 years and on stable anti-hypertensive treatment and blood pressure <150/95 mm Hg will be recruited. No new drugs will be introduced during the study.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | December 1, 2023 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility | Inclusion Criteria: - Diagnosis of hypertension - Stable antihypertensive treatment at least 8 weeks prior to inclusion - One to four antihypertensive drugs Exclusion Criteria: - Atrial fibrillation/flutter - Diabetes - Previous stroke or TIA - Heart failure - Ischemic heart disease - Peripheral artery disease - Malignant disease with less than one year expected survival - Inability to follow study protocol (for instance shift work) |
Country | Name | City | State |
---|---|---|---|
Sweden | Sahlgrenska University Hospital, Mölndal | Gothenburg | |
Sweden | Närhälsan Billingen Primary Health Care Centre | Skövde | |
Sweden | Närhälsan Norrmalm Primary Health Care Centre | Skövde |
Lead Sponsor | Collaborator |
---|---|
Vastra Gotaland Region | Swedish Heart Lung Foundation |
Sweden,
2018 Practice Guidelines for the management of arterial hypertension of the European Society of Hypertension and the European Society of Cardiology: ESH/ESC Task Force for the Management of Arterial Hypertension: Erratum. J Hypertens. 2019 Feb;37(2):456. doi: 10.1097/HJH.0000000000002026. No abstract available. — View Citation
Bilo G, Grillo A, Guida V, Parati G. Morning blood pressure surge: pathophysiology, clinical relevance and therapeutic aspects. Integr Blood Press Control. 2018 May 24;11:47-56. doi: 10.2147/IBPC.S130277. eCollection 2018. — View Citation
Bowles NP, Thosar SS, Herzig MX, Shea SA. Chronotherapy for Hypertension. Curr Hypertens Rep. 2018 Sep 28;20(11):97. doi: 10.1007/s11906-018-0897-4. Erratum In: Curr Hypertens Rep. 2018 Dec 4;21(1):1. — View Citation
Callaway E, Ledford H. Medicine Nobel awarded for work on circadian clocks. Nature. 2017 Oct 2;550(7674):18. doi: 10.1038/nature.2017.22736. No abstract available. — View Citation
Fujiwara T, Hoshide S, Yano Y, Kanegae H, Kario K. Comparison of morning vs bedtime administration of the combination of valsartan/amlodipine on nocturnal brachial and central blood pressure in patients with hypertension. J Clin Hypertens (Greenwich). 2017 Dec;19(12):1319-1326. doi: 10.1111/jch.13128. Epub 2017 Nov 5. — View Citation
Hermida RC, Crespo JJ, Dominguez-Sardina M, Otero A, Moya A, Rios MT, Sineiro E, Castineira MC, Callejas PA, Pousa L, Salgado JL, Duran C, Sanchez JJ, Fernandez JR, Mojon A, Ayala DE; Hygia Project Investigators. Bedtime hypertension treatment improves cardiovascular risk reduction: the Hygia Chronotherapy Trial. Eur Heart J. 2020 Dec 21;41(48):4565-4576. doi: 10.1093/eurheartj/ehz754. — View Citation
Hermida RC. Sleep-time ambulatory blood pressure as a prognostic marker of vascular and other risks and therapeutic target for prevention by hypertension chronotherapy: Rationale and design of the Hygia Project. Chronobiol Int. 2016;33(7):906-36. doi: 10.1080/07420528.2016.1181078. Epub 2016 May 24. — View Citation
Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Difference in score of Epworth sleepiness scale between 8 and 16 weeks | Epworth sleepiness scale score registered by the patients according to time of antihypertensive drug intake | 8 and 16 weeks | |
Other | Perceived side effects 8 weeks | Perceived side effects registered by the patients (VAS) according to time of antihypertensive drug intake | 8 weeks | |
Other | Perceived side effects 16 weeks | Perceived side effects registered by the patients (VAS) according to time of antihypertensive drug intake | 16 weeks | |
Primary | 24 hours blood pressure changes between 8 and 16 weeks. | Ambulatory blood pressure changes between 8 and 16 weeks. Systolic and diastolic mean blood pressure level. | 8 and 16 weeks | |
Primary | Change of dipping of blood pressure between 8 and 16 weeks. | Ratio between daytime and nighttime blood pressure registered after 8 and 16 weeks. Systolic and diastolic mean blood pressure level. | 8 and 16 weeks | |
Secondary | Daytime blood pressure changes between 8 and 16 weeks. | Ambulatory daytime blood pressure registered after 8 and 16 weeks. Systolic and diastolic mean blood pressure level. | 8 and 16 weeks | |
Secondary | Nighttime blood pressure changes between 8 and 16 weeks. | Ambulatory nighttime blood pressure registered after 8 and 16 weeks. Systolic and diastolic mean blood pressure level. | 8 and 16 weeks | |
Secondary | Office blood pressure changes between 8 and 16 weeks. | Office blood pressure registered after 8 and 16 weeks. Systolic and diastolic mean blood pressure level. | 8 and 16 weeks | |
Secondary | Difference in morning surge of blood pressure between 8 and 16 weeks. | Occurrence of morning (yes/no) | 8 and 16 weeks | |
Secondary | Difference in LDL cholesterol levels between 8 and 16 weeks. | LDL cholesterol changes according to time of intake of antihypertensive drugs | 8 and 16 weeks | |
Secondary | Difference in HDL cholesterol levels between 8 and 16 weeks. | HDL cholesterol changes according to time of intake of antihypertensive drugs | 8 and 16 weeks | |
Secondary | Difference in total cholesterol levels between 8 and 16 weeks. | Total cholesterol changes according to time of intake of antihypertensive drugs | 8 and 16 weeks | |
Secondary | Difference in p-creatinine levels between 8 and 16 weeks. | P-creatinine changes according to time of intake of antihypertensive drugs | 8 and 16 weeks |
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