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

Hypertension research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Hypertension

Sleep Apnea

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:LosartanLosartan 50 mg daily during 6 + 6 weeks

Other:CPAPCPAP during the second 6 week-period

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1Hypertensive Men and Women Without OSA on Losartan (n=30)

2Hypertensive Men and Women With OSA on Losartan (n=30)

3Hypertensive Men and Women with OSA on Losartan and CPAP (n=30)

Study Status

Completed

Start Date: June 2008

Completed Date: February 2014

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: 24 h blood pressure (mean blood pressure; mmHg)

Secondary Outcome: Markers of sympathetic activity, RAAS-activity, cardiovascular biomarkers

Study sponsors, principal investigator, and references

Principal Investigator: Yuksel Peker, Assoc. Prof.

Lead Sponsor: Skaraborg Hospital

Collaborator: Göteborg University

More information:https://clinicaltrials.gov/show/NCT00701428

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