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Losartan in Hypertensive Men With Sleep Apnea Before and on Continuous Positive Airway Pressure (CPAP) Treatment (LosartanPAP)
This study is currently recruiting participants.
Verified by Skaraborg Hospital, November 2009
First Received: June 13, 2008   Last Updated: November 3, 2009   History of Changes
Sponsor: Skaraborg Hospital
Information provided by: Skaraborg Hospital
ClinicalTrials.gov Identifier: NCT00701428
  Purpose

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.


Condition Intervention Phase
Hypertension
Sleep Apnea
Drug: Losartan
Other: CPAP
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Phase 4 Study of Losartan in Hypertensive Men With Obstructive Sleep Apnea Before and After Continuous Positive Airway Pressure (CPAP) Treatment

Resource links provided by NLM:


Further study details as provided by Skaraborg Hospital:

Primary Outcome Measures:
  • 24 h blood pressure (mean blood pressure; mmHg) [ Time Frame: At baseline, after 6 weeks and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Markers of sympathetic activity, RAAS-activity, cardiovascular biomarkers [ Time Frame: At baseline, after 6 weeks and 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: June 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Hypertensive Men Without OSA on Losartan (n=30)
Drug: Losartan
Losartan 50 mg daily during 6 + 6 weeks
2: Active Comparator
Hypertensive Men With OSA on Losartan (n=30)
Drug: Losartan
Losartan 50 mg daily during 6 + 6 weeks
3: Experimental
Hypertensive Men with OSA on Losartan and CPAP (n=30)
Drug: Losartan
Losartan 50 mg daily during 6 + 6 weeks
Other: CPAP
CPAP during the second 6 week-period

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

Ages Eligible for Study:   50 Years to 69 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701428

Contacts
Contact: Yuksel Peker, Assoc. Prof. +46500431000 ext 1894 yuksel.peker@vgregion.se

Locations
Sweden, West Gotaland
Skaraborg Hospital Recruiting
Skoevde, West Gotaland, Sweden, SE 51485
Contact: Yuksel Peker, Ass. Prof         yuksel.peker@vgregion.se    
Principal Investigator: Yuksel Peker, Assoc. Prof.            
Sponsors and Collaborators
Skaraborg Hospital
Investigators
Principal Investigator: Yuksel Peker, Assoc. Prof. Skaraborg Hospital, Sweden
  More Information

No publications provided

Responsible Party: Sleep Medicine Unit, Skaraborg Hospital ( Yuksel Peker, MD, PhD, Associate Professor )
Study ID Numbers: VGSKAS-12916, FoU Sweden, nr 8751
Study First Received: June 13, 2008
Last Updated: November 3, 2009
ClinicalTrials.gov Identifier: NCT00701428     History of Changes
Health Authority: Sweden: Medical Products Agency;   Sweden: Regional Ethical Review Board

Keywords provided by Skaraborg Hospital:
Hypertension
Sleep Apnea
Angiotensin II antagonist
CPAP

Additional relevant MeSH terms:
Losartan
Sleep Apnea Syndromes
Molecular Mechanisms of Pharmacological Action
Apnea
Respiration Disorders
Nervous System Diseases
Vascular Diseases
Dyssomnias
Sleep Disorders
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Sleep Disorders, Intrinsic
Angiotensin II Type 1 Receptor Blockers
Signs and Symptoms
Respiratory Tract Diseases
Therapeutic Uses
Signs and Symptoms, Respiratory
Cardiovascular Diseases
Anti-Arrhythmia Agents
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010