Losartan in Hypertensive Men With Sleep Apnea Before and on Continuous Positive Airway Pressure (CPAP) Treatment
Information source: Skaraborg Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Sleep Apnea
Intervention: Losartan (Drug); CPAP (Other)
Phase: Phase 4
Status: Recruiting
Sponsored by: Skaraborg Hospital Official(s) and/or principal investigator(s):
Yuksel Peker, Assoc. Prof., Principal Investigator, Affiliation: Skaraborg Hospital, Sweden
Overall contact:
Yuksel Peker, Assoc. Prof., Phone: +46500431000, Ext: 1894, Email: yuksel.peker@vgregion.se
Summary
Obstructive sleep apnea (OSA) is a highly prevalent condition in hypertensive patients. The
renin-angiotension-aldosterone-system (RAAS) has a central role in blood pressure control.
An angiotensin-II-antagonist, Losartan, is an effective antihypertensive drug. However, some
patients respond to this drug worse than the others, and it is a clinical praxis to either
increase the dosage and/or add another drug. There is limited data regarding the impact of
antihypertensive drugs in OSA patients, i. e., whether or not OSA may constitute the subgroup
of therapy-resistent hypertensive patients. In the literature, there is no data, either,
whether or not CPAP treatment may have an additive blood pressure lowering impact in this
certain subgroup.
Clinical Details
Official title: Phase 4 Study of Losartan in Hypertensive Men With Obstructive Sleep Apnea Before and After Continuous Positive Airway Pressure (CPAP) Treatment
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: 24 h blood pressure (mean blood pressure; mmHg)
Secondary outcome: Markers of sympathetic activity, RAAS-activity, cardiovascular biomarkers
Detailed description:
OSA is a highly prevalent condition in hypertensive patients and the prevalence is even
higher in patients with drug-resistant hypertension. The
renin-angiotension-aldosterone-system (RAAS) has a central role in blood pressure control.
An angiotensin-II-antagonist, Losartan, has an effective antihypertensive drug. However,
some patients respond to this drug worse than the others, and it is a clinical praxis to
either increase the dosage and/or add another drug. There is limited data regarding the
impact of antihypertensive drugs in OSA patients, i. e., whether or not OSA may constitute
the subgroup of therapy-resistent hypertensive patients. In the literature, there is no
data, either, whether or not CPAP treatment may have an additive blood pressure lowering
impact in this certain subgroup. We will include 90 otherwise healthy, untreated
hypertensive men (age 50-69 yrs, Body-Mass-Index <35 kg/m2; 60 patients with OSA, 30
non-OSA) as described above. Before start of treatment, fasting blood samples will be drawn
regarding the neuroendocrine hormones (adrenaline, noradrenaline, plasma renin activity,
angiotensin II,aldosterone, pro-BNP) and cardiovascular biomarkers (CRP,interleukines,
cytokines). All subjects will start with Losartan 50 mg and 24 h- blood-pressure response
and blood sample analysis will be compared between OSA and non-OSA subjects after 6 weeks of
treatment. In the second 6-week period, all subjects will continue with Losartan while the
half of the OSA group (n=30) will be randomized to CPAP and the other 30 patients will
continue with Losartan only.
Eligibility
Minimum age: 50 Years.
Maximum age: 69 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Body Mass Index <35 kg/m2
- Systolic Blood Pressure >=140 mmHg and/or Diastolic Blood Pressure >=95 mmHg
- No known clinical disease except hypertension
- No cardiovascular medication
- Apnea-Hypopnea Index < 5/h (no OSA), or Apnea Hypopnea Index >=15/h (OSA)
Exclusion Criteria:
- Manifest diabetes, liver- or kidney disease Signs of atrial fibrillation or former
myocardial infarction at electrocardiogram
Locations and Contacts
Yuksel Peker, Assoc. Prof., Phone: +46500431000, Ext: 1894, Email: yuksel.peker@vgregion.se
Skaraborg Hospital, Skoevde, West Gotaland SE 51485, Sweden; Recruiting
Yuksel Peker, Assoc. Prof., Principal Investigator
Additional Information
Starting date: June 2008
Ending date: December 2009
Last updated: January 21, 2009
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