Cardiovascular DiseasesABPMNCT05264090
Possibilities of Interpreting the Night-to-Day Ratio Specified by 24-hour Blood Pressure Monitoring
A study testing Ambulatory blood pressure monitoring, Combined aerobic-resistance exercise and The cardiovascular exercise in people with Cardiovascular Diseases, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Ambulatory blood pressure monitoring, Combined aerobic-resistance exercise and The cardiovascular exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 171 participants
- Where
- 1 siteCzechia
- Study dates
- 20 Jun 2018to 20 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Seven-day Ambulatory Blood Pressure Monitoring and CAVI in the Prevention of Cardiovascular Diseases
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
Read the 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).
- Conditions
- Cardiovascular Diseases
- Being tested
- Ambulatory blood pressure monitoring, Combined aerobic-resistance exercise, The cardiovascular exercise
- Keywords
- ambulatory blood pressure monitoring, hypertension, night-to-day ratio, exercise
- Medical subject headings
- Cardiovascular Diseases, Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory blood pressure monitoringOther
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.
Combined aerobic-resistance exerciseOther
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).
The cardiovascular exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | Healthy volunteers without exercise Receives: Other: Ambulatory blood pressure monitoring |
| Group 2 | Sham comparator | Healthy exercise-training volunteers Receives: Other: Ambulatory blood pressure monitoring; Other: Combined aerobic-resistance exercise |
| Group 3 | Active comparator | Patients with ischemic coronary artery disease without exercise Receives: Other: Ambulatory blood pressure monitoring |
| Group 4 | Experimental | Patients with ischemic coronary artery disease following cardiovascular rehabilitation Receives: Other: Ambulatory blood pressure monitoring; Other: The cardiovascular exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 - 7 days
Secondary outcomes (1)
Optimalization of the blood pressure diagnostic through comparing of 24 hours and 7 days monitoring.
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.
Measured: 1 - 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start20 Jun 2018
- Primary completion25 Jun 2020
- Study completion20 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Monocenter, non-randomized, controlled study
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Anne's University Hospital Brno, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk University, University of Minnesota
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264090
- Sponsor's protocol ID
- 24H7D_ABPM
- Acronym
- ABPM
- Status last verified
- Feb 2022
- First submitted
- 9 Feb 2022
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seven-day Ambulatory Blood Pressure Monitoring and CAVI in the Prevention of Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT05264090
- Acronym / sponsor ID
- ABPM / 24H7D_ABPM
- Conditions
- Cardiovascular Diseases
- Keywords
- ambulatory blood pressure monitoring, hypertension, night-to-day ratio, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- St. Anne's University Hospital Brno, Czech RepublicUniversity, hospital or other
- Collaborators
- Masaryk University, University of Minnesota
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 20 Jun 2021 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Monocenter, non-randomized, controlled study
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Other: Ambulatory blood pressure monitoringHealthy volunteers without exercise |
| Group 2 | Sham comparator | Other: Ambulatory blood pressure monitoring, Other: Combined aerobic-resistance exerciseHealthy exercise-training volunteers |
| Group 3 | Active comparator | Other: Ambulatory blood pressure monitoringPatients with ischemic coronary artery disease without exercise |
| Group 4 | Experimental | Other: Ambulatory blood pressure monitoring, Other: The cardiovascular exercisePatients with ischemic coronary artery disease following cardiovascular rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambulatory blood pressure monitoringThe 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. | Other | Group 1, Group 2, Group 3, Group 4 |
| Combined aerobic-resistance exerciseCombined 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). | Other | Group 2 |
| The cardiovascular exerciseThe 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. | Other | Group 4 |
Primary outcome
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.
Time frame: 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.
1 secondary outcome
Optimalization of the blood pressure diagnostic through comparing of 24 hours and 7 days monitoring.
Time frame: 1 - 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulatory blood pressure monitoring, Combined aerobic-resistance exercise and The cardiovascular exercise in people with Cardiovascular Diseases, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1 - 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022; AzTrials last refreshed its copy on 7 Nov 2026.