NCT00701428

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started Jun 2008

Longer than P75 for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

5.5 years

First QC Date

June 13, 2008

Last Update Submit

October 20, 2020

Conditions

HypertensionSleep Apnea

Keywords

HypertensionSleep ApneaAngiotensin II antagonistCPAP

Outcome Measures

Primary Outcomes (1)

  • 24 h blood pressure (mean blood pressure; mmHg)

    Changes from Baseline in 24 h BP at 6 and 12 weeks, respectively

Secondary Outcomes (1)

  • Markers of sympathetic activity, RAAS-activity, cardiovascular biomarkers

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

Study Arms (3)

1

ACTIVE COMPARATOR

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

Drug: Losartan

2

ACTIVE COMPARATOR

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

Drug: Losartan

3

EXPERIMENTAL

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

Drug: LosartanOther: CPAP

Interventions

LosartanDRUG

Losartan 50 mg daily during 6 + 6 weeks

Also known as: Cozaar
123
CPAPOTHER

CPAP during the second 6 week-period

Also known as: Auto-CPAP
3

Eligibility Criteria

Age50 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Manifest diabetes, liver- or kidney disease Signs of atrial fibrillation or former myocardial infarction at electrocardiogram

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Gothenburg, Sahlgrenska Academy

Gothenburg, West Gotaland, SE 41685, Sweden

Location

Related Publications (2)

  • Thunstrom 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.

    PMID: 26414380RESULT

  • Thunstrom 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 Trial. Ann Am Thorac Soc. 2016 Nov;13(11):2002-2011. doi: 10.1513/AnnalsATS.201602-126OC.

    PMID: 27548072RESULT

MeSH Terms

Conditions

HypertensionSleep Apnea Syndromes

Interventions

Losartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Study Officials

  • Yuksel Peker, Prof.

    Göteborg University

    PRINCIPAL INVESTIGATOR

  • Erik Thunström, PhD

    Göteborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Associate Professor

Study Record Dates

First Submitted

June 13, 2008

First Posted

June 19, 2008

Study Start

June 1, 2008

Primary Completion

December 1, 2013

Study Completion

February 1, 2014

Last Updated

October 22, 2020

Record last verified: 2020-10

Locations

SE(1)