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

Sponsor
Skaraborg Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00701428
Collaborator
Göteborg University (Other)
90
Enrollment
1
Location
3
Arms
68
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
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
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Feb 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Hypertensive Men and Women Without OSA on Losartan (n=30)

Drug: Losartan
Losartan 50 mg daily during 6 + 6 weeks
Other Names:
  • 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 Names:
  • 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 Names:
  • Cozaar

    • Other: CPAP
    CPAP during the second 6 week-period
    Other Names:
  • Auto-CPAP

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 24 h blood pressure (mean blood pressure; mmHg) [Changes from Baseline in 24 h BP at 6 and 12 weeks, respectively]

    Secondary Outcome Measures

    1. Markers of sympathetic activity, RAAS-activity, cardiovascular biomarkers [Changes from Baseline in Biomarkers at 6 and 12 weeks, respectively]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 69 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University of Gothenburg, Sahlgrenska Academy Gothenburg West Gotaland Sweden SE 41685

    Sponsors and Collaborators

    • Skaraborg Hospital
    • Göteborg University

    Investigators

    • Principal Investigator: Yuksel Peker, Prof., Göteborg University
    • Principal Investigator: Erik Thunström, PhD, Göteborg University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yuksel Peker, MD, PhD, Associate Professor, Skaraborg Hospital
    ClinicalTrials.gov Identifier:
    NCT00701428
    Other Study ID Numbers:
    • VGSKAS-12916
    • FoU Sweden, nr 8751
    First Posted:
    Jun 19, 2008
    Last Update Posted:
    Oct 22, 2020
    Last Verified:
    Oct 1, 2020
    Keywords provided by Yuksel Peker, MD, PhD, Associate Professor, Skaraborg Hospital
    Hypertension
    Sleep Apnea
    Angiotensin II antagonist
    CPAP
    Additional relevant MeSH terms:
    Apnea
    Sleep Apnea Syndromes
    Hypertension
    Losartan

    Study Results

    No Results Posted as of Oct 22, 2020