Sleep Apnea and Refractory Hypertension: Prevalence and Effect of CPAP Treatment
Sleep Apnea in Patients With Refractory Hypertension: Study of the Prevalence and the Effect of CPAP Treatment on Blood Pressure Control, Endothelial Dysfunction and Angiogenesis.
1 other identifier
interventional
130
1 country
1
Brief Summary
A small number of uncontrolled studies have shown a high prevalence of sleep apnea in patients with refractory hypertension and that CPAP treatment achieves a significant reduction of blood pressure in the short term. The purpose of this study is to assess the prevalence of sleep apnea in patients with refractory hypertension, and the effects of continuous positive pressure treatment on systemic blood pressure and on serum markers of endothelial dysfunction and angiogenesis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hypertension
Started Jan 2005
Typical duration for phase_2 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 11, 2007
CompletedFirst Posted
Study publicly available on registry
April 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedJanuary 29, 2009
January 1, 2009
3.3 years
April 11, 2007
January 27, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of 3 months of CPAP versus conventional pharmacological treatment on the mean 24 h systolic and diastolic blood pressure .
3 months
Secondary Outcomes (1)
Effect of CPAP versus conventional pharmacological treatment on inflammatory, endothelial function and angiogenesis serum biomarkers
3 months
Study Arms (2)
1 CPAP
ACTIVE COMPARATORNasal continuous positive airway pressure
2
NO INTERVENTIONPharmacological treatment alone
Interventions
Eligibility Criteria
You may qualify if:
- Patients referred from a tertiary hospital hypertension clinic with a diagnosis of refractory hypertension on the basis of office blood pressure higher then 160/90 mmHg despite the recommended doses of at least 3 drugs, including a diuretic.
You may not qualify if:
- Causes of secondary hypertension, history of alcohol abuse , renal insufficiency, severe chronically illness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Servei de Pneumologia, Hosital general Universitari Vall d'Hebron
Barcelona, Barcelona, 08035, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lourdes Lozano, MD
Hospital General Universitari Vall d'Hebron
- STUDY CHAIR
Jose Luis Tovar, MD
Hospital General Universitari Vall d'Hebron
- STUDY CHAIR
Gabriel Sampol, MD
Hospital General Universitari Vall d'Hebron
- STUDY CHAIR
Odile Romero, MD
Hospital General Universitari Vall d'Hebron
- STUDY CHAIR
Pilar Chacon, MD
Hospital General Universitari Vall d'Hebron
- STUDY CHAIR
Jose Rios
Universitat Autonoma de Barcelona
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 11, 2007
First Posted
April 13, 2007
Study Start
January 1, 2005
Primary Completion
May 1, 2008
Study Completion
December 1, 2008
Last Updated
January 29, 2009
Record last verified: 2009-01