HypertensionTACITONCT04763629
Effects of Different Exercise Training Programs on Short-term Blood Pressure Variability and Atrial Function in Hypertension
A study testing Physical exercise in people with Hypertension and Coronary Artery Disease, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial summary
The study aim is to compare the effects produced by two different exercise training modalities on short-term blood pressure variability and atrial function evaluated by speckle-tracking echocardiography in hypertensive patients with ischemic heart disease. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Hypertension, Coronary Artery Disease
- What is being tested?
- Physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jan 2021to 22 Dec 2022
- 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertension;
- Coronary artery disease;
- Age over 45 years;
- Male gender
Who cannot join
- Secondary hypertension;
- Significant heart valve diseases;
- Hypertrophic cardiomyopathy;
- Signs and/or symptoms of myocardial ischemia during an ergometric test;
- Uncontrolled arrhythmia;
- Neurological and or orthopedic conditions contraindicating or limiting exercises;
- Significant chronic obstructive pulmonary disease (FEV1 <50%),
- Symptomatic peripheral arterial disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects on Short-term Blood Pressure Variability and Left Atrial Function of Interval Combined Training Versus Continuous Combined Training in Hypertensive Patents With Ischemic Heart Disease.
The study aim is to compare the effects produced by two different exercise training modalities on short-term blood pressure variability and atrial function evaluated by speckle-tracking echocardiography in hypertensive patients with ischemic heart disease. 50 males patients will be randomized to interval combined training (ICT) o0r aerobic continuous combined training (CCT) botrg including aerobic and resistance exercises. The training period will last 12 weeks. The protocol will provide two different assessment of atrial function: -acute: after a single session of exercise; - 12 weeks: at the end of exercise training protocols. 24/h blood pressure variability will be performed before starting the training programs and at 12 weeks.
Read the detailed description
This is a prospective randomized two- arms, single-blinded, parallel trial evaluating the effects of two different exercise training modalities on atrial function, assessed by speckle-tracking echocardiography, and shortt-term blood pressure variability in hypertensive patients with coronary artery disease. First endpoint will be: between-groups comparison of changes in short-term BP variability. Secondary endpoints will be: exercise-induced changes in peak atrial longitudinal strain (PALS); diastolic function, left ventricular strain, 24/h blood pressure values, exercise tolerance. We will include 50 patient with hypertension and underlying coronary artery disease, evaluated for entering a cardiac rehabilitation program. Patients that will be judged suitable for the study will be randomized, with a 1:1 ratio, to interval combined training (ICT) or aerobic continuous combined training (CCT) both including aerobic and resistance exercises. Each patient will undergo three visits. At visit 1 in which patients will perform a first echocardiography with evaluation of the acoustic window and a cardiopulmonary test (for excluding myocardial ischemia and for establishing the training intensity); visit 2- acute evaluation- :patients will undergo an echocardiographic assessment before and within 30 minutes after a single exercise session (alternatively interval or combined training according to the randomization code). Visit 3: at 12 weeks all patient will perform a final echocardiography evaluation, a 24/h blood pressure monitoring and a second cardiopulmonary test. Patients of both groups will exercise three times/week for 12 weeks. Each exercise session will last 80 minutes
- Conditions
- Hypertension, Coronary Artery Disease
- Being tested
- Physical exercise
- Keywords
- atrial function; hypertension; coronary artery disease
- Medical subject headings
- Hypertension, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseOther
Patients of both arms will undergo two different modalities of exercise during the 12 weeks study period.
| Study group | Role | What they receive |
|---|---|---|
| Interval Combined Training (ICT) | Experimental | Patients randomized to this group will perform aerobic exercise on the stationary cycle ergometer using an interval protocol consisting of alternating bouts of 5 minutes at 80-90% of VO₂ peak and 10 minutes at 50-60% of VO₂ peak. This sequence will be repeated three times, resulting in a total aerobic exercise duration of 45 minutes. Then they will perform dynamic resistance exercise lasting 35 minutes at 60% of 1-repetition maximum (1-RM) Receives: Other: Physical exercise |
| Continuous Combined Training (CCT) | Experimental | Patients randomized to this group will perform 45 minutes of cycling at a constant heart rate corresponding to 60-70% of VO₂ peak as determined during cardiopulmonary test. Then they will perform dynamic resistance exercise at 60% of 1-RM involving arms and legs for 35 minutes. Receives: Other: Physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes on peak atrial longitudinal strain
between-groups comparison of exercise-induced changes on peak atrial longitudinal strain
Measured: 12 weeks
Secondary outcomes (1)
changes on left ventricle global longitudinal strain
between-groups comparison of exercise-induced changes on left ventricle global longitudinal strain
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start20 Jan 2021
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Caminiti, Study chair, IRCCS San Raffaele Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763629
- Sponsor's protocol ID
- RP 21/28
- Acronym
- TACITO
- Status last verified
- Jan 2026
- First submitted
- 18 Feb 2021
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects on Short-term Blood Pressure Variability and Left Atrial Function of Interval Combined Training Versus Continuous Combined Training in Hypertensive Patents With Ischemic Heart Disease.
- ClinicalTrials.gov ID
- NCT04763629
- Acronym / sponsor ID
- TACITO / RP 21/28
- Conditions
- Hypertension, Coronary Artery Disease
- Keywords
- atrial function; hypertension; coronary artery disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 21 Feb 2021 (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.
The study aim is to compare the effects produced by two different exercise training modalities on short-term blood pressure variability and atrial function evaluated by speckle-tracking echocardiography in hypertensive patients with ischemic heart disease. 50 males patients will be randomized to interval combined training (ICT) o0r aerobic continuous combined training (CCT) botrg including aerobic and resistance exercises. The training period will last 12 weeks. The protocol will provide two different assessment of atrial function: -acute: after a single session of exercise; - 12 weeks: at the end of exercise training protocols. 24/h blood pressure variability will be performed before starting the training programs and at 12 weeks.
Detailed description
This is a prospective randomized two- arms, single-blinded, parallel trial evaluating the effects of two different exercise training modalities on atrial function, assessed by speckle-tracking echocardiography, and shortt-term blood pressure variability in hypertensive patients with coronary artery disease. First endpoint will be: between-groups comparison of changes in short-term BP variability. Secondary endpoints will be: exercise-induced changes in peak atrial longitudinal strain (PALS); diastolic function, left ventricular strain, 24/h blood pressure values, exercise tolerance. We will include 50 patient with hypertension and underlying coronary artery disease, evaluated for entering a cardiac rehabilitation program. Patients that will be judged suitable for the study will be randomized, with a 1:1 ratio, to interval combined training (ICT) or aerobic continuous combined training (CCT) both including aerobic and resistance exercises. Each patient will undergo three visits. At visit 1 in which patients will perform a first echocardiography with evaluation of the acoustic window and a cardiopulmonary test (for excluding myocardial ischemia and for establishing the training intensity); visit 2- acute evaluation- :patients will undergo an echocardiographic assessment before and within 30 minutes after a single exercise session (alternatively interval or combined training according to the randomization code). Visit 3: at 12 weeks all patient will perform a final echocardiography evaluation, a 24/h blood pressure monitoring and a second cardiopulmonary test. Patients of both groups will exercise three times/week for 12 weeks. Each exercise session will last 80 minutes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interval Combined Training (ICT) | Experimental | Other: Physical exercisePatients randomized to this group will perform aerobic exercise on the stationary cycle ergometer using an interval protocol consisting of alternating bouts of 5 minutes at 80-90% of VO₂ peak and 10 minutes at 50-60% of VO₂ peak. This sequence will be repeated three times, resulting in a total aerobic exercise duration of 45 minutes. Then they will perform dynamic resistance exercise lasting 35 minutes at 60% of 1-repetition maximum (1-RM) |
| Continuous Combined Training (CCT) | Experimental | Other: Physical exercisePatients randomized to this group will perform 45 minutes of cycling at a constant heart rate corresponding to 60-70% of VO₂ peak as determined during cardiopulmonary test. Then they will perform dynamic resistance exercise at 60% of 1-RM involving arms and legs for 35 minutes. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hypertension;
- Coronary artery disease;
- Age over 45 years;
- Male gender
Key exclusion criteria (8 listed)
- Secondary hypertension;
- Significant heart valve diseases;
- Hypertrophic cardiomyopathy;
- Signs and/or symptoms of myocardial ischemia during an ergometric test;
- Uncontrolled arrhythmia;
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 |
|---|---|---|
| Physical exercisePatients of both arms will undergo two different modalities of exercise during the 12 weeks study period. | Other | Continuous Combined Training (CCT), Interval Combined Training (ICT) |
Primary outcome
changes on peak atrial longitudinal strain
Time frame: 12 weeks
between-groups comparison of exercise-induced changes on peak atrial longitudinal strain
1 secondary outcome
changes on left ventricle global longitudinal strain
Time frame: 12 weeks
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 26 Jan 2026.
Related trials for Hypertension
RecruitingObservational study
Diabetes and Heart Disease Risk in Blacks
Cardiovascular Diseases, Diabetes
RecruitingPhase 2
Spironolactone for Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
RecruitingPhase 4
De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
RecruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
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.
Giuseppe Caminiti study chair
IRCCS San Raffaele Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise in people with Hypertension and Coronary Artery Disease, run by IRCCS San Raffaele Roma at 1 site in Italy.
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 8 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 26 Jan 2026. 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 Italy. 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. 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?
changes on peak atrial longitudinal strain (time frame: 12 weeks). 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 26 Jan 2026; AzTrials last refreshed its copy on 30 Oct 2026.