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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 90
Study Start Date: June 2008
Estimated Study Completion Date: February 2014
Estimated 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

Ages Eligible for Study:   50 Years to 69 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Göteborg University
Investigators
Principal Investigator: Yuksel Peker, Assoc. Prof. Skaraborg Hospital, Sweden
  More Information

No publications provided

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
Study First Received: June 13, 2008
Last Updated: July 8, 2013
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:
Apnea
Hypertension
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Losartan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 25, 2014