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Completed

NCT Number: NCT00701428

Losartan in Hypertensive Men and Women With Sleep Apnea Before and on 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.

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Key information

Conditions

Hypertension Apnea Cardiovascular Diseases Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

50 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Gothenburg, Sahlgrenska Academy

Gothenburg, West Gotaland, SE 41685, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Losartan

Drug

Losartan 50 mg daily during 6 + 6 weeks

Other names: Cozaar

CPAP

Other

CPAP during the second 6 week-period

Other names: Auto-CPAP

Primary outcomes

  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 outcomes

  1. Markers of sympathetic activity, RAAS-activity, cardiovascular biomarkers

    Time frame: Changes from Baseline in Biomarkers at 6 and 12 weeks, respectively

Sponsors and collaborators

Lead sponsor

Skaraborg Hospital

Other Gov

Collaborators

  • Göteborg University

Registry information

Official study title

Phase 4 Study of Losartan in Hypertensive Men and Women With Obstructive Sleep Apnea Before and After Continuous Positive Airway Pressure (CPAP) Treatment

Acronym: LosartanPAP

Important dates

Study start
2008
Primary completion
2013
Study completion
2014
First posted
Jun 19, 2008
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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