NCT00616265

Brief Summary

The working hypothesis for the present study is that treatment with CPAP in patients with an sleep apnea (IAH\>15) and AHT-r is capable of producing significant reductions in blood-pressure levels. This hypothesis is supported by four proven findings:

  • To evaluate the effect of treatment with CPAP on the various elements assessed in BP (systolic/diastolic; daytime/nighttime, etc) and the circadian profile (dipper/non-dipper/raiser patterns; variability and homogeneity of blood-pressure levels, etc) obtained during a 24-hour out-patient study (AMPA).
  • To analyze the related variables or subgroups of patients most affected by treatment with CPAP.
  • To evaluate the effect of CPAP on the levels of some of the biological variables involved in the pathogenesis of AHT-r (renin, angiotensin, aldosterone, atrial natriuretic factor, etc).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

February 4, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 29, 2012

Status Verified

February 1, 2012

Enrollment Period

3.5 years

First QC Date

February 4, 2008

Last Update Submit

February 28, 2012

Conditions

Sleep ApneaHypertension

Keywords

Sleep apneaRefractory HypertensionDifficult-to-treat hypertensionCPAP

Outcome Measures

Primary Outcomes (1)

  • Effect on blood pressure levels

    Before and six months after CPAP treatment

Secondary Outcomes (1)

  • Effect on night blood pressure pattern

    Befor and six month after CPAP treatment

Study Arms (2)

B

NO INTERVENTION

Group B. Only Usual Control

A

EXPERIMENTAL

Group A: Cpap treatment plus Usual control

Device: CPAP

Interventions

CPAPDEVICE

Pressure device on airway to maintain it open

Also known as: Continuous positive airway pressure
A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-75 with a diagnosis of primary AHT-r and an AHI ≥15.
  • Signature indicating informed consent.

You may not qualify if:

  • Those patients with, in the opinion of the researcher, incapacitating hypersomnia will be excluded (to avoid the ethical problems associated with not treating a symptomatic sleep apnea patient).
  • Patients with risky professions or work involving dangerous goods.
  • Pregnancy.
  • The regular use of psychotropic drugs that could significantly modify the results of the sleep studies, or previous alcoholism (more than 100 gr of alcohol/day).
  • Patients previously treated with CPAP.
  • Record of poor compliance with anti-hypertensive treatment.
  • AHT secondary to cardiac insufficiency, valvulopathy, renal or endocrinological causes, cor pulmonale or the consumption of oral corticoids, or any other known cause.
  • Known renal insufficiency with a concentration of creatinine greater than 1.5 mg/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Requena

Valencia, Valencia, 42340, Spain

Location

Related Publications (2)

  • Sanchez-de-la-Torre M, Khalyfa A, Sanchez-de-la-Torre A, Martinez-Alonso M, Martinez-Garcia MA, Barcelo A, Lloberes P, Campos-Rodriguez F, Capote F, Diaz-de-Atauri MJ, Somoza M, Gonzalez M, Masa JF, Gozal D, Barbe F; Spanish Sleep Network. Precision Medicine in Patients With Resistant Hypertension and Obstructive Sleep Apnea: Blood Pressure Response to Continuous Positive Airway Pressure Treatment. J Am Coll Cardiol. 2015 Sep 1;66(9):1023-32. doi: 10.1016/j.jacc.2015.06.1315.

    PMID: 26314530DERIVED

  • Martinez-Garcia MA, Capote F, Campos-Rodriguez F, Lloberes P, Diaz de Atauri MJ, Somoza M, Masa JF, Gonzalez M, Sacristan L, Barbe F, Duran-Cantolla J, Aizpuru F, Manas E, Barreiro B, Mosteiro M, Cebrian JJ, de la Pena M, Garcia-Rio F, Maimo A, Zapater J, Hernandez C, Grau SanMarti N, Montserrat JM; Spanish Sleep Network. Effect of CPAP on blood pressure in patients with obstructive sleep apnea and resistant hypertension: the HIPARCO randomized clinical trial. JAMA. 2013 Dec 11;310(22):2407-15. doi: 10.1001/jama.2013.281250.

    PMID: 24327037DERIVED

MeSH Terms

Conditions

Sleep Apnea SyndromesHypertension

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Miguel Angel Martínez-Garcia, MD

    Sociedad Española de Neumología y Cirugía Torácica

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 4, 2008

First Posted

February 15, 2008

Study Start

June 1, 2008

Primary Completion

December 1, 2011

Study Completion

February 1, 2012

Last Updated

February 29, 2012

Record last verified: 2012-02

Locations

ES(1)