ASTREX: Effects of Different Exercise Training on Atrial Function in Hypertension

• Sponsor: IRCCS San Raffaele (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04763629
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15.8
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Coronary Artery Disease	Other: Physical exercise	N/A

Detailed Description

This is a prospective randomized two- arms open 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 or combined training 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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: Jan 20, 2021
• Anticipated Primary Completion Date: Jan 15, 2022
• Anticipated Study Completion Date: May 16, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interval Training (IT) Patients randomized to this group will perform 45 minutes of exercise on treadmill, alternating intervals of ten minutes at 50-60% of VO2 peak and two intervals five miutes at 85-90% of VO2 peak	Other: Physical exercise; Patients of both arms will undergo two different modalities of exercise during the 12 weeks study period.
Experimental: Compbined Training (CT) Patients randomized to this group will perform 45 minutes of exercise in which they will perform aerobic continuous training on tradmill (20 minutes) and resistance training (25 minutes)	Other: Physical exercise; Patients of both arms will undergo two different modalities of exercise during the 12 weeks study period.

Outcome Measures

Primary Outcome Measures

1. changes on peak atrial longitudinal strain [12 weeks]

   between-groups comparison of exercise-induced changes on peak atrial longitudinal strain

Secondary Outcome Measures

1. changes on left ventricle global longitudinal strain [12 weeks]

   between-groups comparison of exercise-induced changes on left ventricle global longitudinal strain

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS San Raffaele Pisana	Rome		Italy	00163

Sponsors and Collaborators

• IRCCS San Raffaele

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Giuseppe Caminiti, MD, physician, cardiologist, IRCCS San Raffaele
• ClinicalTrials.gov Identifier: NCT04763629
• Other Study ID Numbers: IRCCSSRaffaele
• First Posted: Feb 21, 2021
• Last Update Posted: Feb 21, 2021
• Last Verified: Nov 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Giuseppe Caminiti, MD, physician, cardiologist, IRCCS San Raffaele: atrial function; hypertension; coronary artery disease
• Additional relevant MeSH terms: Hypertension; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease

Study Results

No Results Posted as of Feb 21, 2021