Effect of Chronotherapy on Blood Pressure - Time of Intake of Blood Pressure Lowering Drugs

NCT05322967 | Recruiting

• 1 other identifier: VGFOUREG-939529
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Hypertension; Drug Therapy; Primary Health Care

Keywords

Cross-over study

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• Daytime blood pressure changes between 8 and 16 weeks.

  8 and 16 weeks

• Nighttime blood pressure changes between 8 and 16 weeks.

  8 and 16 weeks

• Office blood pressure changes between 8 and 16 weeks.

  8 and 16 weeks

• Difference in morning surge of blood pressure between 8 and 16 weeks.

  8 and 16 weeks

• Difference in LDL cholesterol levels between 8 and 16 weeks.

  8 and 16 weeks

Other Outcomes (3)

• Difference in score of Epworth sleepiness scale between 8 and 16 weeks

  8 and 16 weeks

• Perceived side effects 8 weeks

  8 weeks

• Perceived side effects 16 weeks

  16 weeks

Study Arms (2)

Morning intake

ACTIVE COMPARATOR

Intake of antihypertensive medication in the morning

Other: Time of ordinary antihypertensive medication intake

Bedtime intake

ACTIVE COMPARATOR

Intake of antihypertensive medication at bedtime

Other: Time of ordinary antihypertensive medication intake

Interventions

Time of ordinary antihypertensive medication intake OTHER

Time of ordinary antihypertensive medication intake

Bedtime intake; Morning intake

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of hypertension
• One to four antihypertensive drugs

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Swedish Heart Lung Foundation: collaborator

Study Sites (3)

Sahlgrenska University Hospital, Mölndal

Gothenburg, Sweden

RECRUITING

Närhälsan Billingen Primary Health Care Centre

Skövde, 541 41, Sweden

RECRUITING

Närhälsan Norrmalm Primary Health Care Centre

Skövde, 541 41, Sweden

NOT YET RECRUITING

Related Publications (8)

• 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.

  PMID: 31641769 BACKGROUND

• 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.

  PMID: 27221952 BACKGROUND

• 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.

  PMID: 29106031 BACKGROUND

• 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.

  PMID: 1798888 BACKGROUND

• 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.

  PMID: 29872338 BACKGROUND

• 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.

  PMID: 30267334 BACKGROUND

• 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.

  PMID: 28980662 BACKGROUND

• 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.

  PMID: 30640882 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Karin Manhem, Prof, MD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristina B Boström, Prof, MD

CONTACT

0702409091; kristina.a.bengtsson@vgregion.se

Georgios Mourtzinis, PhD, MD

CONTACT

0735522153; georgios.mourtzinis@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: It is not possible to mask patients, care provider or investigators but the outcome assessors are masked for allocation of patients
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants are randomized in the initial phase to take their ordinary anti-hypertensive medication in the morning or at bedtime for 8 weeks. Then the participants are switching to the alternative intervention during 8 weeks in the second phase of the study.

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 12, 2022
• Study Start: June 25, 2022
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 20, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)