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

St. Anne's University Hospital Brno, Czech Republic

Status: Completed

Conditions: Cardiovascular Diseases

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05264090

24H7D_ABPM

Details and patient eligibility

About

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

Full 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).

Enrollment: 171 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

171 participants in 4 patient groups, including a placebo group

Group 1

Placebo Comparator group

Description:

Healthy volunteers without exercise

Treatment:

Other: Ambulatory blood pressure monitoring

Group 2

Sham Comparator group

Description:

Healthy exercise-training volunteers

Treatment:

Other: Combined aerobic-resistance exercise

Other: Ambulatory blood pressure monitoring

Group 3

Active Comparator group

Description:

Patients with ischemic coronary artery disease without exercise

Treatment:

Other: Ambulatory blood pressure monitoring

Group 4

Experimental group

Description:

Patients with ischemic coronary artery disease following cardiovascular rehabilitation

Treatment:

Other: The cardiovascular exercise

Other: Ambulatory blood pressure monitoring