Circadian Disruption And Cardiovascular Risk In Young Adults With Hypertension

NCT07770958 | Active Not Recruiting DMC

• 2 other identifiers: CIRCA-HT STUDYBG-RRP-2.004-0004-C01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study will investigate whether circadian disruption is associated with higher blood pressure and a less favorable cardiovascular profile in young adults aged 18 to 45 years with essential arterial hypertension. Participants will undergo 14 days of wrist actigraphy using the CamNtech MotionWatch 8, 24-hour ambulatory blood pressure monitoring, cardiovascular assessment, laboratory testing, and validated questionnaires assessing perceived stress and insomnia symptoms. Circadian disruption will be classified using a predefined five-component research index based on actigraphy measures. Participants with three or more abnormal circadian indicators will be classified as Circadian Disruption Index-positive and compared with participants with zero to two abnormal indicators. The primary outcome is mean 24-hour systolic blood pressure. Secondary outcomes include nocturnal blood pressure patterns, cardiac structure and function, heart-rate variability, stress, insomnia symptoms, and individual circadian measures. The Circadian Disruption Index is a study-specific research classification and is not intended to diagnose a circadian rhythm sleep-wake disorder.

Conditions

Essential Arterial Hypertension; Circadian Disruption

Keywords

Arterial hypertension; Essential hypertension; Circadian disruption; Circadian rhythm; Sleep-wake rhythm; Actigraphy; Ambulatory blood pressure monitoring; 24-hour blood pressure; Cardiovascular risk Young adults

Outcome Measures

Primary Outcomes (1)

• Mean 24-Hour Systolic Blood Pressure

  Mean systolic blood pressure over a valid 24-hour ambulatory blood pressure monitoring period performed during the 14-day actigraphy recording period.

  During the 14-day actigraphy period

Secondary Outcomes (17)

• Mean 24-Hour Diastolic Blood Pressure

  During the 14-day actigraphy period

• Mean Nocturnal Systolic Blood Pressure

  During the 14-day actigraphy period

• Mean Nocturnal Diastolic Blood Pressure

  During the 14-day actigraphy period

• Nocturnal Systolic Blood Pressure Dipping

  During the 14-day actigraphy period

• Non-Dipping and Reverse-Dipping Blood Pressure Pattern

  During the 14-day actigraphy period

Study Arms (2)

CDI-Positive

Participants with three or more abnormal criteria among the five predefined components of the Circadian Disruption Index.

CDI-Negative

Participants with zero to two abnormal criteria among the five predefined components of the Circadian Disruption Index.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adults aged 18 to 45 years with established essential arterial hypertension who meet all predefined eligibility criteria. Participants will be recruited from the clinical population of the participating study center. The study population will include both male and female participants. Individuals with shift work or night-duty work, secondary hypertension, previously diagnosed circadian rhythm sleep-wake disorders, clinically significant sleep-related breathing disorders, diabetes mellitus, significant cardiovascular disease other than uncomplicated essential hypertension, clinically significant renal or endocrine disease, or other conditions likely to substantially affect circadian rhythm or blood pressure measurements will be excluded.

You may qualify if:

• Adults aged 18 to 45 years.
• Established diagnosis of essential arterial hypertension.
• Stable antihypertensive treatment for at least 4 weeks before enrollment, when pharmacological treatment is prescribed.
• Ability and willingness to undergo 14 consecutive days of wrist actigraphy using the CamNtech MotionWatch 8.
• Ability and willingness to undergo 24-hour ambulatory blood pressure monitoring.
• Ability to provide written informed consent.

You may not qualify if:

• Shift work or night-duty work.
• Known secondary hypertension.
• Previously diagnosed circadian rhythm sleep-wake disorder.
• Known obstructive sleep apnea or other clinically significant sleep-related breathing disorder.
• Known clinically significant cardiovascular disease other than uncomplicated essential arterial hypertension.
• Diabetes mellitus.
• Chronic kidney disease with clinically significant renal impairment.
• Active thyroid disease or other clinically significant endocrine disorder that may affect blood pressure or circadian rhythm.
• Current treatment with medications known to substantially alter sleep-wake rhythm or circadian timing.
• Regular use of hypnotic or sedative medication that could substantially affect actigraphic sleep assessment.
• Pregnancy.
• Inability to comply with study procedures or insufficient actigraphy/ABPM recording quality.
• Any acute illness or unstable medical condition that, in the investigator's opinion, could substantially influence the study outcomes.

Sponsors & Collaborators

• Medical University of Sofia: lead

Study Sites (1)

UMHAT " Tcaritca Yanna - ISUL"

Sofia, Sofia, 1000, Bulgaria

Location

MeSH Terms

Conditions

Hypertension; Essential Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Assistant Professor, Specialist in Cardiology

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 18, 2026
• Study Start: September 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)