Cardiac Hemodynamics in Overlap Syndrome (COPD With Obstructive Sleep Apnea)

NCT01261377 | Withdrawn Phase 1 DMC

• 1 other identifier: 2010-P001753
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

Patients with both sleep apnea and COPD have overlap syndrome, but their optimal management is not known. We plan to conduct a randomized trial of of bi-level PAP vs. night time oxygen to asses the impact of intervention on cardiac MRI and biomarkers.

Conditions

Chronic Obstructive Airway Disease

Keywords

COPD, obstructive sleep apnea, OSA, BPAP, CPAP

Outcome Measures

Primary Outcomes (1)

• Right ventricular end-diastolic volume

  Six months

Secondary Outcomes (6)

• Other cardiac hemodynamics parameters (end-systolic volume, ejection fraction, mass index and wall motion of right and left ventricles, coronary blood flow, pulmonary artery pressure and blood flow, etc.)

  Six months

• Serum inflammatory biomarkers (C-reactive protein, interleukin-6, ICAM-1 and P-selectin)

  Six months

• Urine catecholamine level

  Six months

• Flow mediated dilatation of brachial artery

  Six months

• Pulmonary Function tests

  Six months

Study Arms (3)

Bi-level positive airway pressure (BPAP)

ACTIVE COMPARATOR

bi-level will be titrated to optimize oxygenation and ventilation.

Device: Bi-level positive airway pressure (BPAP)

Nocturnal oxygen

ACTIVE COMPARATOR

oxygen will be provided as per standard of care.

Drug: Oxygen

Continuous positive airway pressure

ACTIVE COMPARATOR

The level of CPAP will be titrated to treat OSA. The duration of therapy will be six months.

Device: CPAP

Interventions

Bi-level positive airway pressure (BPAP) DEVICE

The level of BPAP will be titrated to treat OSA as well as hypoxemia and hypercapnia. The duration of therapy will be six months.

Bi-level positive airway pressure (BPAP)

Oxygen DRUG

Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.

Nocturnal oxygen

CPAP DEVICE

The level of CPAP will be titrated to treat OSA. The duration of therapy will be six months.

Continuous positive airway pressure

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both men and women with age more than 18 years.
• Known diagnosis of COPD (GOLD stage 2 or higher).

You may not qualify if:

• Already using CPAP or BPAP device.
• Estimated GFR \<30 ml/min/1.73 m2 or on hemodialysis.
• Women known to be pregnant or planning to be pregnant in next 6 months.
• Cardiac pacemaker, metallic heart valves, metallic implants, claustrophobic.
• Chronic atrial fibrillation or frequent premature ventricular contractions.
• Using lipid-lowering medications, aspirin, oral steroids, steroid-sparing medications or anti-oxidant vitamin supplements.
• If taking sildenafil or related drugs, unable to stop it within 48 hours of the study visit.
• Contraindications to stress cardiac testing: acute myocardial infarction within 48 hours, unstable angina not yet stabilized with medical therapy, ongoing chest pain, active broncho-constriction, uncontrolled cardiac arrhythmia, symptomatic severe aortic stenosis, aortic dissection, acute pulmonary embolism or pericarditis.
• Uncontrolled COPD or acute COPD exacerbation.
• Known chronic inflammatory diseases like lupus or active infection.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Massachusetts General Hospital: collaborator

Study Sites (2)

Massachussets General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Sleep Apnea, Obstructive; Microcephaly, Primary Autosomal Recessive, 6

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Atul Malhotra, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Atul Malhotra, MD

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 16, 2010
• Study Start: November 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 12, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)