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

Hypertension Clinical Trial

— LosartanPAP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00701428
• Other study ID #: VGSKAS-12916
• Secondary ID: FoU Sweden, nr 8
• Status: Completed
• Phase: Phase 4
• Start date: June 2008
• Est. completion date: February 2014

Study information

• Verified date: October 2020
• Source: Skaraborg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Hypertension
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Drug:
• Losartan
Losartan 50 mg daily during 6 + 6 weeks

Other:
• CPAP
CPAP during the second 6 week-period

Locations

Country	Name	City	State
Sweden	University of Gothenburg, Sahlgrenska Academy	Gothenburg	West Gotaland

Sponsors (2)

Lead Sponsor	Collaborator
Skaraborg Hospital	Göteborg University

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Thunström E, Manhem K, Rosengren A, Peker Y. Blood Pressure Response to Losartan and Continuous Positive Airway Pressure in Hypertension and Obstructive Sleep Apnea. Am J Respir Crit Care Med. 2016 Feb 1;193(3):310-20. doi: 10.1164/rccm.201505-0998OC. — View Citation

Thunström E, Manhem K, Yucel-Lindberg T, Rosengren A, Lindberg C, Peker Y. Neuroendocrine and Inflammatory Responses to Losartan and Continuous Positive Airway Pressure in Patients with Hypertension and Obstructive Sleep Apnea. A Randomized Controlled Tri — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 h blood pressure (mean blood pressure; mmHg)		Changes from Baseline in 24 h BP at 6 and 12 weeks, respectively
Secondary	Markers of sympathetic activity, RAAS-activity, cardiovascular biomarkers		Changes from Baseline in Biomarkers at 6 and 12 weeks, respectively