Reduction of Left Ventricular Hypertrophy After Eplerenone Therapy
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|ClinicalTrials.gov Identifier: NCT03186742|
Recruitment Status : Completed
First Posted : June 14, 2017
Last Update Posted : June 14, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension,Essential Obstructive Sleep Apnea Left Ventricular Hypertrophy||Drug: Eplerenone 50 mg Tab||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||125 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Eplerenone on Left Ventricular Hypertrophy in Patients With Resistant Hypertension and Obstructive Sleep Apnoea|
|Actual Study Start Date :||July 1, 2014|
|Actual Primary Completion Date :||January 1, 2017|
|Actual Study Completion Date :||June 1, 2017|
Experimental: Group A
The patients who had Eplerenone 50mg tab once a day added to their standard hypertensive treatment.
Drug: Eplerenone 50 mg Tab
Eplerenone 50 mg Tab once a day
No Intervention: Group B
The patients who did not receive an additional drug to their standard hypertensive treatment.
- Number of patients with reduction of left ventricular hypertrophy after Eplerenone therapy [ Time Frame: 6 months ]Changes in echocardiographic data ( LVED, IVS, LVPW, LVMI, RWT) and in left ventricular geometric patterns after six months Eplerenone treatment
- Reduction in blood pressure after Eplerenone therapy [ Time Frame: 6 months ]Reduction in office BP (measured three times in standard conditions) and in 24-hour ABPM parameters
- Reduction in (AHI) apnea-hypopnea index after Eplerenone therapy [ Time Frame: 6 months ]AHI - parameter determining the severity of OSA in polysomnography
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03186742
|Study Chair:||Andrzej Tykarski, Prof||Department of Hypertension, Angiology and Internal Disease. Poznan University of Medical Sciences, Poland|
|Principal Investigator:||Szczepan Cofta, PhD||Department of Respiratory Diseases, Allergology and Lung Oncology. Poznan University of Medical Sciences, Poland|