Reduction of Left Ventricular Hypertrophy After Eplerenone Therapy
Status:
Completed
Trial end date:
2017-06-01
Target enrollment:
Participant gender:
Summary
Obstructive sleep apnea syndrome (OSA) is the most frequent sleep disorder characterized by
excessive decrease in muscle tone of the soft palate, the tongue and the posterior pharyngeal
wall. It leads to airway collapse. In cases of decreased airway passage hypoventilation
(hypopnea) occurs while periodic lack of airflow is called apnea. An obstructive sleep apnea
syndrome is recognized as an independent cardiovascular risk factor. OSA is very common in
patients with resistant hypertension. RAH is diagnosed when blood pressure remains elevated
despite simultaneous use of 3 antihypertensive agents from different groups of drugs at
optimal to maximum doses, including a diuretic.
In patients with OSA frequent episodes of hypoxemia during sleep result in the repeated
activation of the sympathetic nervous system. What is more, the episodes of respiratory
disorders increases in levels of aldosterone serum concentration with following sodium and
water retention and elevation of blood pressure finally. An increased aldosterone level also
stimulates synthesis of collagen, promotes stiffening of the arterial wall, myocardial
fibrosis with heart muscle remodeling and takes part in development of left ventricular
hypertrophy (LVH) - common complication of hypertensive patients with OSA. Several studies,
including the Sleep Heart Health Study have confirmed that severe OSA is associated with high
prevalence of concentric hypertrophy through sympathetic activation and vasoconstriction.
Eplerenone is a selective mineralocorticoid receptor inhibitor. It has no affinity for
glucocorticoid, progesterone and androgen receptors and therefore has lower risk of side
effects. Eplerenone lowers blood pressure and inhibits heart muscle fibrosis. The hypotensive
effect is caused by reduction of fluid retention. Probably, in patients with OSA, a reduction
of fluid accumulation especially at the level of the neck may contribute to lowering the
resistance in the upper respiratory tract and in that way it may help to decrease the
severity of OSA.
As LVH remains a strong and independent predictor of total mortality and death from
cardiovascular causes, in this study we want to assess whether the addition of Eplerenone to
a standard antihypertensive therapy will favorably change left ventricular geometry. We also
want to check if the addition the Eplerenone to a standard antihypertensive therapy could be
an effective therapeutic option for patients with OSA and RAH.