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

NCT05264090 | Completed

• 1 other identifier: 24H7D_ABPM
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiovascular Diseases

Keywords

ambulatory blood pressure monitoring; hypertension; night-to-day ratio; exercise

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  1 - 7 days

Secondary Outcomes (1)

• Optimalization of the blood pressure diagnostic through comparing of 24 hours and 7 days monitoring.

  1 - 7 days

Study Arms (4)

Group 1

PLACEBO COMPARATOR

Healthy volunteers without exercise

Other: Ambulatory blood pressure monitoring

Group 2

SHAM COMPARATOR

Healthy exercise-training volunteers

Other: Ambulatory blood pressure monitoring; Other: Combined aerobic-resistance exercise

Group 3

ACTIVE COMPARATOR

Patients with ischemic coronary artery disease without exercise

Other: Ambulatory blood pressure monitoring

Group 4

EXPERIMENTAL

Patients with ischemic coronary artery disease following cardiovascular rehabilitation

Other: Ambulatory blood pressure monitoring; Other: The cardiovascular exercise

Interventions

Ambulatory blood pressure monitoring OTHER

The ambulatory monitoring (7-day ABPM) was performed with ambulatory blood pressure monitoring devices TM-2430 (A\&D; Tokyo, Japan) based on both the cuff-oscillometric and Korotkoff sound method. The cuff was placed on the non-dominant arm according to the same rules applying to casual auscultation measurement. The monitoring device with a weight of 250 g was worn by the monitored subjects in a waist-fixed case continuously for 7 days except for times involving personal hygiene. During every automatic measurement, the arm was resting and hung along the body. The device automatically recorded all the regular measurements for seven days, between 6:00 a.m. and 10:00 p.m. every 30 minutes and between 10:00 p.m. and 6:00 a.m. every 60 minutes. Such short intervals are necessary to obtain a sufficient number of representative measurements.

Group 1; Group 2; Group 3; Group 4

Combined aerobic-resistance exercise OTHER

Combined aerobic-resistance exercise (group 2) was scheduled twice weekly in the form of 60-minute workouts with a load intensity at the level of sub-maximum heart frequency (75-85% SFmax). The minimum time span between the workouts was 24 hours. The workout consisted of a 10-minute warm-up, 25 minutes of aerobic exercise (spinning bicycle or bicycle ergometer), 15 minutes of resistance exercise on gym machines (bench press, leg extension and pull down) with 40-50% 1-RM (one repetition maximum) intensity (3 series of 10 exercises), and a 10-minute cool-down (stretching of the main muscle groups).

Group 2

The cardiovascular exercise OTHER

The cardiovascular exercise (group 4) took the form of sixty-minute workouts scheduled two to three times weekly. The nature of the workouts was similar, combined aerobic-resistance exercise (a 10-minute warm-up, aerobic endurance on bicycle ergo meter for 25 minutes, resistance exercise on multifunctional gym machines for 15 minutes, and a 10-minute cool-down). The workout intensity was set at the level of the first ventilation threshold (VAT-1), corresponding to the following workout parameters: load (W) and heart rate (HR).19,20 The resistance exercise intensity was specified by the 1-RM (one repetition maximum) method. The maximum load lifted across the full range of motion for every exercise was used as the benchmark for the workload intensity specification, corresponding to 30 - 60% 1-RM.

Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Anne's University Hospital Brno, Czech Republic: lead
• Masaryk University: collaborator
• University of Minnesota: collaborator

Study Sites (1)

St. Anne´s University Hospital Brno

Brno, 654 91, Czechia

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Hypertension; Motor Activity

Condition Hierarchy (Ancestors)

Vascular Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocenter, non-randomized, controlled study

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 3, 2022
• Study Start: June 20, 2018
• Primary Completion: June 25, 2020
• Study Completion: June 20, 2021
• Last Updated: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)