Status:
RECRUITING
Inspiratory Muscle Strength Training in Chronic Kidney Disease
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
University of Colorado, Boulder
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Chronic Kidney Diseases
Hypertension
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
More than 80% of individuals with chronic kidney disease have concomitant hypertension and the majority fail to achieve blood pressure control \<130/80 mmHg, leading to high risk of cardiovascular dis...
Detailed Description
Chronic kidney disease (CKD) is a major public health concern that has reached epidemic proportions. Hypertension is a leading modifiable risk factor for cardiovascular disease (CVD) and end-stage kid...
Eligibility Criteria
Inclusion
- Aged 50 years or older; women must be post-menopausal
- Chronic kidney disease stage 3 or 4 (estimated glomerular filtration rate with the 4 CKD-EPI 2021 race-free equation: 20-59 mL/min/1.73m\^2; stable renal function in the past 3 months)
- History of inadequately controlled hypertension (systolic blood pressure 120-159 mmHg on two separate days) and on a stable antihypertensive regimen for the past 6 weeks
- Weight stable in the prior 3 months (\<2 kg weight change) and willing to remain weight stable throughout the study. Participants using glucagon-like peptide-1 receptor agonists or planning to start them during the study are excluded unless they have achieved weight stability for at least 3 months prior to enrollment.
- Ability to provide informed consent
Exclusion
- Patients with advanced chronic kidney disease requiring chronic dialysis
- Significant pulmonary disorders including: chronic obstructive pulmonary disease, interstitial lung disease, cystic fibrosis, or uncontrolled asthma
- History of spontaneous pneumothorax, collapsed lung due to traumatic injury that has not fully healed, burst eardrum that has not fully healed, or other conditions of the eardrum
- Significant co-morbid conditions with a life expectancy of \< 1 year
- History of severe congestive heart failure (i.e., ejection fraction \<35%)
- History of hospitalization within the last month
- Albuminuria (albumin to creatinine ratio \> 2200 mg/g
- Current smoker
- Immunosuppressant agents taken in the past 12 months. Steroids used for the treatment of gout are acceptable; however, patients should not be using steroids within 2 weeks (or 14 days) prior to the vascular testing (rationale: may confound vascular testing)
- Known malignancy
- Inability to cooperate with or clinical contraindication for magnetic resonance imaging including: severe claustrophobia, implants, devices, or non-removable body piercings (these individuals can participate in the study but are excluded from the MRI procedure)
- Illicit drug use or alcohol dependence/abuse, which in the opinion of the investigators, would prohibit compliance with the study intervention
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04911491
Start Date
March 1 2022
End Date
July 1 2026
Last Update
May 2 2025
Active Locations (1)
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1
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, United States, 80045