Health TrialsbyHealthPanel

Vascular Endothelial Dysfunction in Sleep Apnea

ConditionObstructive Sleep Apnea of Adult
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University

About this trial

This double-blind placebo-controlled parallel group randomized study design will be used to test whether 4 weeks of atorvastatin 10 mg daily reduces levels of inflammatory markers in OSA patients treated with CPAP (standard of care). The purpose of this study is to investigate: 1) whether statins reduce endothelial inflammation and pro-thrombotic conditions in OSA, including in patients adherent to CPAP (Aim 1); and 2) whether statins reduce endothelial inflammation and pro-thrombotic conditions by improving endothelial cholesterol metabolism and trafficking in OSA (Aim 2).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥18 years

Newly diagnosed with obstructive sleep apnea (OSA) who were never treated with CPAP. OSA is defined as apnea-hypopnea index (AHI) ≥5 events/hour of sleep.

Disqualifiers

A history of coronary artery disease, heart failure, stroke, diabetes, malignancy, chronic pulmonary, kidney or rheumatologic disease, muscle pain/fatigue, smoking within the past 5 years

Regular use of any medications

Trial design

Design model

Parallel

Treatments tested in this trial

  • Atorvastatin 10mg

    Drug

    Atorvastatin 10 mg daily for 28 days will be randomly allocated to OSA patients regardless of adherence with CPAP. Atorvastatin and placebo will be encapsulated to appear identical and dispensed by the research pharmacy.

  • Placebo

    Drug

    Placebo daily for 28 days will be randomly allocated to OSA patients regardless of adherence with CPAP. Atorvastatin and placebo will be encapsulated to appear identical and dispensed by the research pharmacy.

  • Continuous Positive Airway Pressure Therapy

    Other intervention

    CPAP is a standard of care for OSA and will be prescribed by care providers not associated with this study based on clinical indications. The investigators will have no role in prescribing CPAP.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: TreatmentActive comparator 2 interventions
Group B: ControlPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Circulating levels of Angiopoietin-2 after 4 weeks of atorvastatin vs. placebo therapy

Mean circulating levels of Ang-2 will be quantified after 4 weeks of statin or placebo therapy by enzyme-linked immunosorbent assay (ELISA)

Time frame
4 weeks post-treatment
2

Interaction of endoplasmic reticulum (ER)-bound vesicle-associated membrane protein-associated protein B (VAPB) with late endosome-bound ORP1L (proximity ligation assay fluorescence area in µm2) after 4 weeks of atorvastatin vs. placebo therapy

Mean Interactions ER-bound VAPB with late endosome-bound ORP1L in harvested endothelial cells (ECs) will be assessed using proximity ligation assay (DuoLink, fluorescence area in µm2) after 4 weeks of atorvastatin or placebo therapy

Time frame
4 weeks post-treatment

Secondary outcomes

1

Circulating levels of von Willebrand factor cleavage products after 4 weeks of atorvastatin vs. placebo

Mean Circulating levels (count) of von Willebrand factor (vWF) cleavage products (low molecular weight (LMW), medium molecular weight (IMW), high molecular weight (HMW)) after 4 weeks of atorvastatin vs. placebo

Time frame
4 weeks post-treatment
2

Circulating levels of von Willebrand factor (vWF) cleavage products (low, medium, high molecular weight) at baseline and after 4 weeks of CPAP

Mean Circulating levels (count) of vWF cleavage products (LMW, IMW, HMW) at baseline and after CPAP.

Time frame
4 weeks post-CPAP
3

Endothelial cell free cholesterol levels after 4 weeks of atorvastatin vs. placebo

Mean Endothelial cell free cholesterol levels (fluorescence intensity) after 4 weeks of atorvastatin vs. placebo therapy

Time frame
4 weeks post-treatment
4

Endothelial cell lipid droplets after 4 weeks of atorvastatin vs. placebo

Mean Endothelial cell lipid droplets (fluorescence area µm2) after 4 weeks of atorvastatin vs. placebo

Time frame
4 weeks post-treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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