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

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ClinicalTrials.gov Identifier: NCT00701428
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
Göteborg University
Information provided by (Responsible Party):
Yuksel Peker, Skaraborg Hospital

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
Hypertension Sleep Apnea Drug: Losartan Other: CPAP 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.

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Study Type : Interventional  (Clinical Trial)
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 : June 2008
Actual Primary Completion Date : December 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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 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




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


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Older Adult)
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

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
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Sweden
University of Gothenburg, Sahlgrenska Academy
Gothenburg, West Gotaland, Sweden, SE 41685
Sponsors and Collaborators
Skaraborg Hospital
Göteborg University
Investigators
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Principal Investigator: Yuksel Peker, Prof. Göteborg University
Principal Investigator: Erik Thunström, PhD Göteborg University
Publications of Results:
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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: June 19, 2008    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Keywords provided by Yuksel Peker, Skaraborg Hospital:
Hypertension
Sleep Apnea
Angiotensin II antagonist
CPAP
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Hypertension
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
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