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Losartan in Hypertensive Men and Women With Sleep Apnea Before and on Continuous Positive Airway Pressure (CPAP) Treatment (LosartanPAP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00701428
First Posted: June 19, 2008
Last Update Posted: November 18, 2014
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.
Collaborator:
Göteborg University
Information provided by (Responsible Party):
Yuksel Peker, Skaraborg Hospital
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Losartan in Hypertensive Men and Women With Obstructive Sleep Apnea Before and After Continuous Positive Airway Pressure (CPAP) Treatment

Resource links provided by NLM:


Further study details as provided by Yuksel Peker, Skaraborg Hospital:

Primary Outcome Measures:
  • 24 h blood pressure (mean blood pressure; mmHg) [ Time Frame: Changes from Baseline in 24 h BP at 6 and 12 weeks, respectively ]

Secondary Outcome Measures:
  • Markers of sympathetic activity, RAAS-activity, cardiovascular biomarkers [ Time Frame: Changes from Baseline in Biomarkers at 6 and 12 weeks, respectively ]

Enrollment: 90
Study Start Date: June 2008
Study Completion Date: February 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Hypertensive Men and Women Without OSA on Losartan (n=30)
Drug: Losartan
Losartan 50 mg daily during 6 + 6 weeks
Other Name: Cozaar
Active Comparator: 2
Hypertensive Men and Women With OSA on Losartan (n=30)
Drug: Losartan
Losartan 50 mg daily during 6 + 6 weeks
Other Name: Cozaar
Experimental: 3
Hypertensive Men and Women with OSA on Losartan and CPAP (n=30)
Drug: Losartan
Losartan 50 mg daily during 6 + 6 weeks
Other Name: Cozaar
Other: CPAP
CPAP during the second 6 week-period
Other Name: Auto-CPAP

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. The investigators will include 90 otherwise healthy, untreated hypertensive men and women(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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00701428


Locations
Sweden
Skaraborg Hospital
Skoevde, West Gotaland, Sweden, SE 51485
Sponsors and Collaborators
Skaraborg Hospital
Göteborg University
Investigators
Principal Investigator: Yuksel Peker, Assoc. Prof. Skaraborg Hospital, Sweden
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yuksel Peker, MD, PhD, Associate Professor, Skaraborg Hospital
ClinicalTrials.gov Identifier: NCT00701428     History of Changes
Other Study ID Numbers: VGSKAS-12916
FoU Sweden, nr 8751
First Submitted: June 13, 2008
First Posted: June 19, 2008
Last Update Posted: November 18, 2014
Last Verified: November 2014

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

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