Clinical trial NCT04763629: Effects of Different Exercise Training on Atrial Function in Hypertension
Official title: Comparative Acute and 12-weeks Effects on Left Atrial Function of Combined Training Versus Interval Training in Hypertensive Patents: the Atrial STRain EXercise (ASTREX) Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Coronary Artery Disease
Keywords: atrial function; hypertension; coronary artery disease
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 40
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aim is to compare the effects produced by two different exercise training modalities on atrial function evaluated by speckle-tracking echocardiography on hypertensive patients with coronary artery disease. 50 males patients will be randomized to interval training or combined training the latter including both 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.

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, on hypertensive patients with coronary artery disease. First endpoint will be: between-groups comparison of exercise-induced changes on peak atrial longitudinal strain (PALS). Secondary endpoints will be: exercise-induced changes on diastolic function and left ventricular strain. 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 training (IT) or combined training (CT) the latter including both 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 an ergometric 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 and a second ergometric test. Patients of both groups will exercise three times/week for 12 weeks. Each exercise session will last 45 minutes

Eligibility criteria: Inclusion Criteria:

* Hypertension;
* Coronary artery disease;
* Age over 45 years;
* Male gender

Exclusion Criteria:

* 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

Primary outcomes:
measure: changes on peak atrial longitudinal strain
timeFrame: 12 weeks
Secondary outcomes:
measure: changes on left ventricle global longitudinal strain
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Rome
country: Italy
facility: IRCCS San Raffaele Pisana
Study officials:
affiliation: IRCCS San Raffaele Rome
name: Giuseppe Caminiti
role: STUDY_CHAIR
References: