Study protocol for a randomized controlled trial

Fontes-Carvalho, Ricardo;
Sampaio, Francisco; Teixeira, Madalena; Gama, Vasco; Leite-Moreira,
Adelino.

Trials, December 2015, Vol. 16 Issue: Number 1 p1-6, 6p;
Abstract: Exercise training is effective in improving functional
capacity and quality of life in patients with coronary artery disease,
but its effects on left ventricular systolic and diastolic function are
controversial. Diastolic dysfunction is a major determinant of adverse
outcome after myocardial infarction and, contrary to systolic function,
no therapy or intervention has proved to significantly improve
diastolic function. Data from animal studies and from patients with
diastolic heart failure has suggested that exercise training can have a
positive effect on diastolic function parameters.
This trial aims to evaluate if a structured exercise training program
can improve resting left ventricular diastolic and systolic function in
patients who have had an acute myocardial infarction.
This is a phase II, prospective, randomized, open-label,
blinded-endpoint trial that will include at least 96 consecutive
patients who have had an acute myocardial infarction one month
previously. Patients will be randomized (1:1) to an exercise training
program or a control group, receiving standard of care. At enrolment,
and at the end of the follow-up period, patients will be submitted to
an echocardiography (with detailed assessment of diastolic and systolic
function using recent consensus guidelines), cardiopulmonary exercise
testing, an anthropometric assessment, blood testing, and clinical
evaluation. Patients randomized to the intervention group will be
submitted to an eight-week outpatient exercise program, combining
endurance and resistance training, for three sessions per week. The
primary endpoint will be the change in lateral E’ velocity immediately
after the eight-week exercise training program. Secondary endpoints
will include other echocardiographic parameters of left ventricular
diastolic and systolic function, cardiac structure, metabolic and
inflammation biomarkers (high-sensitivity C-reactive protein and
pro-BNP), functional capacity (peak oxygen consumption and anaerobic
threshold) and anthropometric measurements.                   New
strategies that can improve left ventricular diastolic function are
clinically needed. This will be the first trial to evaluate, in
patients who have had an acute myocardial infarction, the effects of a
structured program of exercise training on diastolic and systolic
function, assessed by novel echocardiographic parameters.