deltatrials
Completed PHASE4 INTERVENTIONAL 2-arm NCT01508754

Efficacy of CPAP Treatment on Blood Pressure of Resistant Hypertension Patients With Obstructive Sleep Apnea Syndrome

Efficacy of Continuous Positive Airway Pressure (CPAP) on Blood Pressure Control of Resistant Hypertension Patients With Obstructive Sleep Apnea Syndrome (OSAS).

Sponsor: Conselho Nacional de Desenvolvimento Científico e Tecnológico

Updated 5 times since 2017 Last updated: Sep 12, 2014 Started: Jan 31, 2012 Primary completion: Aug 31, 2014 Completion: Aug 31, 2014
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE4 trial investigates Obstructive Sleep Apnea Syndrome and Resistant Hypertension and is currently completed. Conselho Nacional de Desenvolvimento Científico e Tecnológico leads this study, which shows 5 recorded versions since 2012 — indicating limited longitudinal coverage. Heart and vascular conditions benefit from the kind of long-term tracking this trial provides.

Study Description(click to expand)

Obstructive sleep apnea syndromes (OSAS) have been demonstrated to be highly prevalent in patients with resistant hypertension (defined as uncontrolled clinic BP despite being on anti-hypertensive treatment with at least 3 drugs in optimal doses and including a diuretic). Nevertheless, the effect of treating OSAS with Continuous Positive Airway Pressure (CPAP) device on clinic and ambulatory BPs in patients with resistant hypertension is largely unknown. Hence, the primary aim of this randomized clinical trial is to evaluate the effect of CPAP on BP levels in resistant hypertensive patients with moderate-severe OSAS (defined as an apnea-hypopnea index \[AHI\] greater than 15 on a full polysomnographic examination). Two-hundred patients will be randomly allocated either to treatment with CPAP device plus their usual anti-hypertensive treatment or to continue their usual treatment alone for 6 months. Clinic and 24-hour ambulatory BP monitoring, laboratory evaluation (including microalbuminuria and aldosterone-to-renin ratio), 24-hour Holter monitoring, ergospirometric treadmill test, and carotid-femoral pulse wave velocity measurement will be performed before and after the 6-month treatment, with the observers blinded to the allocation group.

Obstructive sleep apnea syndromes (OSAS) have been demonstrated to be highly prevalent in patients with resistant hypertension (defined as uncontrolled clinic BP despite being on anti-hypertensive treatment with at least 3 drugs in optimal doses and including a diuretic). Nevertheless, the effect of treating OSAS with Continuous Positive Airway Pressure (CPAP) device on clinic and ambulatory BPs in patients with resistant hypertension is largely unknown. Hence, the primary aim of this randomized clinical trial is to evaluate the effect of CPAP on BP levels in resistant hypertensive patients with moderate-severe OSAS (defined as an apnea-hypopnea index \[AHI\] greater than 15 on a full polysomnographic examination). Two-hundred patients will be randomly allocated either to treatment with CPAP device plus their usual anti-hypertensive treatment or to continue their usual treatment alone for 6 months. Clinic and 24-hour ambulatory BP monitoring, laboratory evaluation (including microalbuminuria and aldosterone-to-renin ratio), 24-hour Holter monitoring, ergospirometric treadmill test, and carotid-femoral pulse wave velocity measurement will be performed before and after the 6-month treatment, with the observers blinded to the allocation group.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

5 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE4

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE4

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE4

  5. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE4

    First recorded

Jan 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Financiadora de Estudos e Projetos
  • Universidade Federal do Rio de Janeiro
Data source: Universidade Federal do Rio de Janeiro

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations