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Reduction of Left Ventricular Hypertrophy After Eplerenone Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03186742
Recruitment Status : Completed
First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Information provided by (Responsible Party):
Beata Krasinska, Poznan University of Medical Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension,Essential Obstructive Sleep Apnea Left Ventricular Hypertrophy Drug: Eplerenone 50 mg Tab Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
Drug Information available for: Eplerenone

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. Reduction in (AHI) apnea-hypopnea index after Eplerenone therapy [ Time Frame: 6 months ]
    AHI - parameter determining the severity of OSA in polysomnography

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • confirmation of resistant hypertension(RAH). RAH was recognized when in spite of the use of at least 3 antihypertensive agents (including a diuretic) in maximum doses, it was impossible to achieve the target values of BP (< 140/90 mmHg).
  • diagnosing of moderate or severe sleep apnea (OSA) on the basis of apnoea-hypopnea index (AHI) in polysomnography. AHI was defined by the total number of apnoea's and hypopneas per hour of sleep. The severity of OSA was determined as: mild (AHI 5-15), moderate (AHI 15 - 30) and severe (AHI ≥ 30)
  • signing informed and written consent to participation in the study.

Exclusion Criteria:

  • secondary hypertension (other than primary hyperaldosteronism),
  • myocardial infarction,
  • stroke within 6 months before the study,
  • congestive heart failure with New York Heart Association (NYHA) grade III-IV,
  • chronic kidney disease (GFR < 30 ml/min),
  • active addiction to alcohol or psychoactive substances,
  • active cancer disease.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03186742

Sponsors and Collaborators
Poznan University of Medical Sciences
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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

Publications of Results:

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Responsible Party: Beata Krasinska, Principal Investigator, Poznan University of Medical Sciences Identifier: NCT03186742     History of Changes
Other Study ID Numbers: 565/14
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Beata Krasinska, Poznan University of Medical Sciences:
Concentric hypertrophy
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Hypertrophy, Left Ventricular
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Pathological Conditions, Anatomical
Heart Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents
Antihypertensive Agents