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

Chronic Kidney Diseases Clinical Trial

Official title:

Impact of Obstructive Sleep Apnea Treatment on Blood Pressure Control in Chronic Kidney Disease: A Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05846490
• Other study ID #: 64401922.8.0000.0068
• Status: Recruiting
• Phase: Phase 4
• Start date: January 8, 2024
• Est. completion date: May 2026

Study information

• Verified date: June 2024
• Source: University of Sao Paulo
• Contact: Luciano Drager, MD, PhD
• Phone: 5511-26617686
• Email: luciano.drager[@]incor.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Apnea
• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP
Continuous positive airway pressure + anti-hypertensive treatment intensification (if necessary)

Drug:
• Usual care
Anti-hypertensive treatment intensification (if necessary)

Locations

Country	Name	City	State
Brazil	Fernanda Trani Ferreira	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-hypertensive intensification	Percentage of patients that required treatment modification aiming at blood pressure control	1 year
Secondary	Systolic and diastolic blood pressure change by office measurement and ambulatory blood pressure monitoring	Absolute blood pressure change	1 year
Secondary	Nocturnal blood pressure dipping	Assessment of nocturnal blood pressure dipping using ambulatory blood pressure monitoring	1 year
Secondary	Estimated glomerular filtration rate (eGFR)	Impact of OSA treatment with CPAP on eGFR	1 year
Secondary	Albuminuria	Impact of OSA treatment with CPAP on the evolution of albuminuria	1 year
Secondary	Target organ damage using echocardiogram and fundoscopy	Impact of OSA treatment with CPAP on target organ damage such as grade of retinopathy and cardiac remodeling (left ventricular mass index, diastolic dysfunction, etc. by echocardiography).	1 year
Secondary	End-stage renal disease (need of dialysis)	Impact of OSA treatment with CPAP on the possible delay for renal replacement therapy or end-stage renal disease (eGFR <15ml/min)	1 year
Secondary	Continuous analysis of Quality of life	Impact of OSA treatment with CPAP on the quality of life (measured by 36-Item Short Form Health Survey). The lowest and highest possible scores are 0 and 100, respectively. The lower the score the higher impairment in quality of life.	1 year