Effects of Metoprolol and Amlodipine on Cardiac Remodeling, Arrhythmias and Blood Pressure Variation in Hypertensive Patients With Sleep Apnea Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Obstructive sleep apnea (OSA) is a highly prevalent chronic sleep disorder that affects 3% to 7% in middle aged individuals and increases with age. OSA has been identified as the most common secondary cause associated with resistant hypertension. There is evidence that compared with older patients, the risk of hypertension in OSA patients may be particularly pronounced in younger adult ones (less than 50 years).

Traditionally, cardiovascular risk stratification in hypertensive patients was based on the average blood pressure (BP) measured in the clinic. Accumulated data has shown that target-organ damage is related not only to 24-h mean intra-arterial BP, but also to BP variability (BPV) in subjects with essential hypertension. Growing evidence demonstrated that BPV has considerable prognostic value for all-cause mortality and cardiovascular outcomes, independent of average BP. In addition, it has been found that hypoxia condition in pneumoconiosis patients was closely associated with exaggerated BPV in ambulatory BP. However, the selections of antihypertensive drugs remain yet not very clearly for hypertensive patients combined with OSA.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effects of Nifedipine and Metoprolol on Blood Pressure Variability in Northern Chinese

NCT02513927

Hypertension

UNKNOWN PHASE2/PHASE3

Tight Hemodynamic Control in Patients Who Are Chronically on Metoprolol

NCT01404767

Vascular Disease Hypertension Angina +1 more

TERMINATED PHASE4

Metoprolol and Formoterol in Chronic Obstructive Pulmonary Disease (COPD)

NCT00288548

Chronic Obstructive Pulmonary Disease (COPD)

UNKNOWN PHASE4

A Multi-Center Study on the Metoprolol Optimal Dosing Pathway of Metoprolol Application in Chinese Patients With Acute Coronary Syndrome

NCT03413410

ACS - Acute Coronary Syndrome

UNKNOWN NA

Efficacy and Safety of Nebivolol Versus Metoprolol in Hypertensive Subject Taking Amlodipine

NCT03635125

JNC 7 Stage 1 or 2 Hypertension

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Obstructive sleep apnea (OSA) is a highly prevalent chronic sleep disorder that affects 3% to 7% in middle aged individuals and increases with age. It is considered an important independent contributing factor for the development of hypertension, diabetes and heart rhythm disorders. The prevalence of arterial hypertension has been reported to reach 50% of patients with OSA. OSA has been identified as the most common secondary cause associated with resistant hypertension. There is evidence that compared with older patients, the risk of hypertension in OSA patients may be particularly pronounced in younger adult ones (less than 50 years).

Traditionally, cardiovascular risk stratification in hypertensive patients was based on the average blood pressure (BP) measured in the clinic. Accumulated data has shown that target-organ damage is related not only to 24-h mean intra-arterial BP, but also to BP variability (BPV) in subjects with essential hypertension. Growing evidence demonstrated that BPV has considerable prognostic value for all-cause mortality and cardiovascular outcomes, independent of average BP. In addition, it has been found that hypoxia condition in pneumoconiosis patients was closely associated with exaggerated BPV in ambulatory BP. However, the selections of antihypertensive drugs remain yet not very clearly for hypertensive patients combined with OSA.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Apnea Syndrome Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

OSA-amlodipine

To observe the effects of amlodipine (5mg) on blood pressure variation after 12 weeks of treatment

Group Type EXPERIMENTAL

Amlodipine

Intervention Type DRUG

Amlodipine was given orally in a dose of 5mg/day to treat patients in the OSA-amlodipine group for 12 weeks.

OSA-metoprolol

To observe the effects of metoprolol (47.5mg) on blood pressure variation after 12 weeks of treatment

Group Type EXPERIMENTAL

metoprolol

Intervention Type DRUG

Metoprolol was given orally in a dose of 47.5mg/day to treat patients in the OSA-metoprolol group for 12 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Amlodipine

Amlodipine was given orally in a dose of 5mg/day to treat patients in the OSA-amlodipine group for 12 weeks.

Intervention Type DRUG

metoprolol

Metoprolol was given orally in a dose of 47.5mg/day to treat patients in the OSA-metoprolol group for 12 weeks.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Men aged between 18 and 75 included years old, and
* Postmenopausal women who are no more than 75 years older.
* Patients with essential mild to moderate uncomplicated hypertension (DBP\<110mmHg and SBP\<180mmHg measured with a validated automatic device in sitting position) after initiation or intensification of appropriate healthy lifestyle modification,
* Without antihypertensive treatment in 2 weeks.

Exclusion Criteria

* History of cerebrovascular disease: ischemic stroke, cerebral haemorrhage and TIA.
* History of cardiovascular disease:unstable angina, myocardial infarction, coronary revascularization and congestive heart failure.
* History of renal impairment.
* History of Type I diabetes mellitus or Type II diabetes uncontrolled.
* History of liver impairment.
* History of alcoholism or drug abuse.
* Known symptomatic orthostatic hypotension.
* Contra-indications to treatment with investigate products.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No