CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 125 enrolled
Drug / intervention
Eplerenone 50 mg Tabdrug
Likely dose
Eplerenone 50 mg Tabfrom record
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Search/NCT03186742
NCT03186742Phase 4Completed

Effects of Eplerenone on Left Ventricular Hypertrophy in Patients With Resistant Hypertension and Obstructive Sleep Apnoea

Poznan University of Medical Sciences·interventional·Posted Jun 14, 2017·Updated Jun 14, 2017

In Brief

A Phase 4 clinical trial evaluating Eplerenone 50 mg Tab for Hypertension,Essential and 2 related conditions. Completed, enrolled 125 participants.

Detailed 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.

Study Details

Study Typeinterventional
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Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 14, 2017
Enrollment StartJul 1, 2014
Primary CompletionJan 1, 2017
Study CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 9.0 years ago

Interventions

Eplerenone 50 mg Tabdrug

Eplerenone 50 mg Tab once a day