Possibilities of Interpreting the Night-to-Day Ratio Specified by 24-hour Blood Pressure Monitoring

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Other: Ambulatory blood pressure monitoring; Other: Combined aerobic-resistance exercise; Other: The cardiovascular exercise

• Registration Number: NCT05264090
• Lead Sponsor: St. Anne's University Hospital Brno, Czech Republic

Brief Summary

Specify the risk rate of incorrect patient classification based on night-to-day ratio specification from singular 24-h ABPM in comparison to the results of 7-day ABPM monitoring

Detailed Description

The subjects in the study are divided into 4 groups:

group 1 (40 healthy men and women without exercise); group 2 (40 healthy exercise-training men and women); group 3 (40 patients with ischemic coronary artery disease without exercise); and group 4 (51 patients with ischemic coronary artery disease following cardiovascular rehabilitation).

The subject of the evaluation is the percentage rate of incorrect subject classification (dipper, non-dipper, extreme dipper, and risers) based on the mean blood pressure values for 7 days and from seven independent 24-hour cycles (the mean value mode).

Study Timeline

• Study Start: 2018-06-20
• Primary Completion: 2020-06-25
• Study Completion: 2021-06-20
• Status Verified: 2022-02
• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-21
• Last Update Submitted: 2022-02-21
• Study First Posted: 2022-03-03
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

Inclusion Criteria

• Healthy volunteers (without any disease, including the cardiovascular ones, and without any kind of treatment)
• Patients with chronic ischemic coronary artery disease
• Patients treated with ACE inhibitors, beta-blockers or statins.
• To visit routinely in the health centres where the study is carried out

Exclusion Criteria

• Age under 18 years,
• Pregnant, or breast-feeding,
• Patients on dialysis or being followed by nephrology,
• Severe physical or cognitive limitations,
• Intolerance to the method of measurement

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Ambulatory blood pressure monitoring	Healthy volunteers without exercise
Group 2	Ambulatory blood pressure monitoring	Healthy exercise-training volunteers
Group 2	Combined aerobic-resistance exercise	Healthy exercise-training volunteers
Group 3	Ambulatory blood pressure monitoring	Patients with ischemic coronary artery disease without exercise
Group 4	The cardiovascular exercise	Patients with ischemic coronary artery disease following cardiovascular rehabilitation
Group 4	Ambulatory blood pressure monitoring	Patients with ischemic coronary artery disease following cardiovascular rehabilitation

Primary Outcome Measures

Name	Time	Method
The risk rate of incorrect patient classification based on night-to-day ratio specification from singular 24-h ABPM in comparison to the results of 7-day ABPM monitoring.	1 - 7 days	Primary outcome was to specify the risk rate of incorrect patient classification based on night-to-day ratio specification from singular 24-h ABPM in comparison to the results of 7-day ABPM monitoring.; The percentage of blood pressure drop at night expressed by night-to-day ratio (dippers, non-dippers, extreme dippers, reverse dippers) can be specified much more accurately on the basis of 7-day ABPM values. ABPM restricted to 24 h, as currently practiced, does not yield a sufficiently reliable estimate of the night-to-day ratio for a classification in terms of dipping. Extending monitoring to 7 days accounts for the large day-to-day variability in the night-to-day ratio, and may yield a more reliable diagnosis of blood pressure variability.

Secondary Outcome Measures

Name	Time	Method
Optimalization of the blood pressure diagnostic through comparing of 24 hours and 7 days monitoring.	1 - 7 days	On the basis of the obtained results, the following procedure can be recommended for clinical practice. If the standard 24-hour monitoring is used, then obtain at least 3 mutually independent 24-hour cycle data for every examined individual. If at least two of them result in the same night-to-day ratio and the third night-to-day ratio is only slightly different, the thus obtained index can be considered trustworthy. Otherwise, the correct night-to-day ratio can only be obtained by 7-day ABPM and, in addition, the resulting night-to-day ratio calculated from the mean values obtained in the course of the 7 days must be compared to the result modes obtained for the individual monitoring days.; The magnitude of the difference between the evaluation of 24-hour and 7-days blood pressure records was not dependent on the gender, age, health, or cardiovascular disease or physical activity of monitored individuals.

Trial Locations

Locations (1)

St. Anne´s University Hospital Brno; 🇨🇿 Brno, Czechia