Lifestyle program to help blood pressure and kidney health in adults with advanced CKD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-site randomized trial comparing a structured lifestyle intervention delivered through a cardiac rehabilitation setting to usual kidney health education in adults with advanced chronic kidney disease. Participants will be randomized to receive a multi-component program—including diet modification, supervised exercise sessions, and wellness coaching—or standard care for 12 weeks. The study aims to determine whether the lifestyle program can improve systolic blood pressure and other factors associated with CKD progression. Primary outcomes focus on blood pressure changes, with secondary assessments related to kidney function and cardiovascular risk factors. The trial is conducted at Duke University with NHLBI collaboration.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Black race; ≥18 years old
* history of hypertension
* SBP ≥120 or DBP ≥80 mm Hg average of three measurements at screening visit (per KDIGO recommended SBP target of \<120 mm Hg)48
* Stable anti-hypertensive medication regimen (i.e., no medication changes 4 weeks prior to enrollment);
* eGFR of 15-44 ml/min/1.73m2 at screening visit
* agreeable to randomization to either of the 2 study arms

Exclusion Criteria:

* currently receiving or needing dialysis; having received or needing a kidney transplant
* acute kidney injury at time of screening
* average SBP ≥ 180 mm Hg or DBP ≥ 110 mm Hg at screening
* Exaggerated systolic response during ETT (e.g., SBP \>210 mmHg in men or \>190 mmHg in women)
* underweight (BMI \<18.5 kg/m2)
* planned weight loss surgery in 1 year
* a score of 27 or higher on the BP medication adherence scale
* cardiac condition that would preclude participation in aerobic exercise training, including severe ischemic heart disease (CCS Class 3 or 4 angina or evidence of ischemia at \<85% heart rate reserve on screening treadmill testing), severe heart failure (NYHA Class 3 or 4), high grade arrhythmias, severe valvular heart disease
* severe asthma or chronic obstructive lung disease
* musculoskeletal or neurologic conditions that would preclude participation in aerobic exercise training
* a major psychiatric disorder
* illicit drug abuse
* current alcohol consumption \>14 drinks/week for men and \>7 drinks/week for women
* pregnant or planned pregnancy within 1 year
* gastric bypass surgery within the last 2 years
* a life-limiting comorbid medical condition, such as cancer.
* physical limitation, gait instability, or need for continuous weight-bearing support that, in the opinion of study staff, would prevent safe completion of exercise treadmill testing

Where it's running

• Sarah W Stedman Nutrition & Metabolism Center
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Crystal Tyson, MD, MHS — Duke University
• Study coordinator: Crystal Tyson, MD
• Email: crystal.simpson@duke.edu
• Phone: 919-660-6860

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.