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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Skaraborg Hospital
Sponsor:
Collaborator:
Göteborg University
Information provided by (Responsible Party):
Yuksel Peker, Skaraborg Hospital
ClinicalTrials.gov Identifier:
NCT00701428
First received: June 13, 2008
Last updated: July 8, 2013
Last verified: July 2013

June 13, 2008
July 8, 2013
June 2008
December 2013   (final data collection date for primary outcome measure)
24 h blood pressure (mean blood pressure; mmHg) [ Time Frame: Changes from Baseline in 24 h BP at 6 and 12 weeks, respectively ] [ Designated as safety issue: No ]
24 h blood pressure (mean blood pressure; mmHg) [ Time Frame: At baseline, after 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00701428 on ClinicalTrials.gov Archive Site
Markers of sympathetic activity, RAAS-activity, cardiovascular biomarkers [ Time Frame: Changes from Baseline in Biomarkers at 6 and 12 weeks, respectively ] [ Designated as safety issue: No ]
Markers of sympathetic activity, RAAS-activity, cardiovascular biomarkers [ Time Frame: At baseline, after 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Losartan in Hypertensive Men and Women With Sleep Apnea Before and on Continuous Positive Airway Pressure (CPAP) Treatment
Phase 4 Study of Losartan in Hypertensive Men and Women With Obstructive Sleep Apnea Before and After Continuous Positive Airway Pressure (CPAP) Treatment

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypertension
  • Sleep Apnea
  • 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
  • Active Comparator: 1
    Hypertensive Men and Women Without OSA on Losartan (n=30)
    Intervention: Drug: Losartan
  • Active Comparator: 2
    Hypertensive Men and Women With OSA on Losartan (n=30)
    Intervention: Drug: Losartan
  • Experimental: 3
    Hypertensive Men and Women with OSA on Losartan and CPAP (n=30)
    Interventions:
    • Drug: Losartan
    • Other: CPAP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
February 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
50 Years to 69 Years
No
Contact: Yuksel Peker, Assoc. Prof. +46500431000 ext 1894 yuksel.peker@vgregion.se
Sweden
 
NCT00701428
VGSKAS-12916, FoU Sweden, nr 8751
Yes
Yuksel Peker, Skaraborg Hospital
Skaraborg Hospital
Göteborg University
Principal Investigator: Yuksel Peker, Assoc. Prof. Skaraborg Hospital, Sweden
Skaraborg Hospital
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP