Impact of Obstructive Sleep Apnea (OSA) Treatment on Blood Pressure Control in Chronic Kidney Disease

NCT05846490 | Recruiting Phase 4

• 1 other identifier: 64401922.8.0000.0068
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The role of obstructive sleep apnea (OSA) on chronic kidney disease (CKD) is not clear. This randomized clinical trial will test the impact of OSA treatment on blood pressure (BP) and on the estimated glomerular filtration rate (eGFR) in patients with CKD IIIb and IV (eGFR 44-15 ml/min). A polygraph will be performed to assess the presence of OSA (defined by an apnea-hypopnea index ≥15 events/hour). Patients with OSA will be randomized to use continuous positive upper airway pressure (CPAP) or to maintain optimized clinical treatment for BP control. Antihypertensive medication adjustments will be allowed using a standard protocol for both groups by the same researcher, who will not have access to CPAP follow-up. In addition to clinical (including BP and ambulatory BP monitoring, ABPM) and laboratory assessments at baseline, we will follow up at 3 months, 6 months, 9 months and 12 months after randomization of the proposed outcomes. Target organ damage analyses, such as the retina and echocardiography, will be performed at baseline and after 1 year of randomization. Primary objective: to compare the effect of CPAP on the need to adjust antihypertensive medication to control systolic BP (\<130mmHg) in patients with CKD; secondary objectives: 1) to evaluate the reduction in systolic and diastolic BP by office and ABPM; 2) assessment of nocturnal BP dipping; 3) to evaluate the impact of OSA treatment with CPAP on eGFR during follow-up; 4) to evaluate the impact of OSA treatment with CPAP on the evolution of albuminuria; 5) assessment of other target organ damage such as retinopathy and cardiac remodeling; 6) to evaluate the impact of OSA treatment with CPAP on the possible delay for renal replacement therapy or end-stage renal disease (eGFR \<15ml/min and dialysis); 7) to evaluate the impact of OSA treatment with CPAP on the quality of life of patients with CKD. With a significance level of 5% and study power of 90%, two-tailed hypothesis testing, 74 patients with OSA per group, i.e., 148 patients in total, will be required to assess the primary endpoint (we estimate that 25% and 50% of patients in control and CPAP groups will not need to adjust their antihypertensive medication at follow-up, respectively).

Conditions

Sleep Apnea; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Anti-hypertensive intensification

  Percentage of patients that required treatment modification aiming at blood pressure control

  1 year

Secondary Outcomes (7)

• Systolic and diastolic blood pressure change by office measurement and ambulatory blood pressure monitoring

  1 year

• Nocturnal blood pressure dipping

  1 year

• Estimated glomerular filtration rate (eGFR)

  1 year

• Albuminuria

  1 year

• Target organ damage using echocardiogram and fundoscopy

  1 year

Study Arms (2)

Continuous positive airway pressure (CPAP)

EXPERIMENTAL

Standard OSA treatment + BP adjustments with anti-hypertensive therapy

Device: CPAP

Usual Care

ACTIVE COMPARATOR

BP adjustments with anti-hypertensive therapy

Drug: Usual care

Interventions

CPAP DEVICE

Continuous positive airway pressure + anti-hypertensive treatment intensification (if necessary)

Continuous positive airway pressure (CPAP)

Usual care DRUG

Anti-hypertensive treatment intensification (if necessary)

Usual Care

Eligibility Criteria

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

You may qualify if:

• Confirmed diagnosis of hypertension: Use of oral antihypertensive drugs or systolic BP (SBP) \>140 mmHg and/or diastolic BP (DBP) \>90 mmHg on 2 office measurements or \>130x80 mmHg (24 hours ABPM).
• eGFR by the CKD-EPI equation between 45 ml/min/1.73m2 and 15 ml/min/1.73m2 (in conservative treatment of CKD).

You may not qualify if:

• Professional drivers;
• Home supplemental oxygen users;
• Patients under current treatment for OSA;
• Pregnant women;
• Patients with malignant neoplasms or terminal illnesses;
• Severe asthma or chronic obstructive pulmonary disease;
• Patients with systemic lupus erythematosus, amyloidosis or systemic sclerosis;
• Patients with a history of solid organ transplants.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Fernanda Trani Ferreira

São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Luciano Drager, MD, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciano Drager, MD, PhD

CONTACT

5511-26617686; luciano.drager@incor.usp.br

Fernanda Trani Ferreira, MD

CONTACT

5511-26617686; tranifernanda@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: May 6, 2023
• Study Start: January 8, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

BR (1)