Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD

NCT05928936 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: IRB00078214a2R01HL135183
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 2

Brief Summary

The goals of this project are to investigate the mechanisms and potential therapies related to exercise capacity in persons with chronic kidney disease (CKD).

Conditions

Chronic Kidney Disease

Keywords

Exercise training; Sodium bicarbonate; Exercise pressor reflex

Outcome Measures

Primary Outcomes (1)

• Change in Exercise Capacity

  Exercise capacity measured as VO2 peak during a maximal treadmill exercise test. Higher VO2 max indicates increased oxygen consumption and improved fitness.

  Baseline, Week 12

Secondary Outcomes (7)

• Change in Systolic Blood Pressure

  Baseline, Week 12

• Change in Diastolic Blood Pressure

  Baseline, Week 12

• Change in Muscle Sympathetic Nerve Activity (MSNA)

  Baseline, Week 12

• Change in Interleukin 6 (IL-6)

  Baseline, Week 12

• Change in T2 relaxation of muscle water (T2water)

  Baseline, Week 12

Study Arms (3)

Exercise Training plus Sodium Bicarbonate

EXPERIMENTAL

Participants with CKD will undergo exercise training for 20-45 minutes, 3 times per week, for 12 weeks. Additionally, participants take 650-1300 mg of sodium bicarbonate twice daily.

Drug: Sodium Bicarbonate; Behavioral: Exercise Training

Exercise Training plus Placebo

ACTIVE COMPARATOR

Participants with CKD will undergo exercise training for 20-45 minutes, 3 times per week, for 12 weeks. Additionally, participants take placebo tablets to match 650-1300 mg of sodium bicarbonate twice daily.

Behavioral: Exercise Training; Drug: Placebo

Healthy control

NO INTERVENTION

Baseline measurements in healthy participants without CKD will be measured and compared to participants with CKD. Healthy controls will not receive any interventions.

Interventions

Sodium Bicarbonate DRUG

Participants take 650-1300 mg of sodium bicarbonate orally twice daily. Serum bicarbonate levels are measured at baseline and then every 2-4 weeks throughout the trial. Doses will be adjusted or held to avoid metabolic alkalosis.

Exercise Training plus Sodium Bicarbonate

Exercise Training BEHAVIORAL

Exercise training consists of progressive, interval-based "Spin" exercise on stationary bicycles three times per week for 12 weeks, led by a certified exercise physiologist. The duration of each session begins at 20 minutes and is increased by 1 to 2 minutes as tolerated to a goal of 45 minutes per session. Exercise intensity begins at low levels (50% of maximal heart rate reserve (HRR)) and increases by 5% every week to a goal of 75% maximal HRR. Each session includes a 5-min warm up, then an interval-based, work-out phase that includes steady up-tempo cadences, sprints, and climbs, followed by a 5-minute cool down.

Exercise Training plus Placebo; Exercise Training plus Sodium Bicarbonate

Placebo DRUG

Participants take placebo pills to match 650-1300 mg of sodium bicarbonate orally twice daily.

Exercise Training plus Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with CKD (Stages III and IV), kidney transplant recipients with varying degrees of kidney function, or persons without kidney disease as matched study controls
• sedentary and do not regularly exercise (defined as exercising \< 20 minutes twice per week)
• CKD patients must have stable renal function (no greater than a decline of estimated glomerular filtration (eGFR) of 1 cc/min/1.73 m2 per month over the prior 6 months) and baseline serum bicarbonate 22-24 mmol/L
• comorbid hypertension

You may not qualify if:

• severe CKD (eGFR\<15 cc/min)
• metabolic alkalosis
• current treatment with bicarbonate
• ongoing drug or alcohol abuse
• diabetic neuropathy, autonomic dysfunction
• any serious disease that might influence survival
• anemia with hemoglobin \<10 g/dL
• clinical evidence of heart failure
• volume overload or ejection fraction below 45%
• symptomatic heart disease by EKG, stress test, and/or history
• treatment with central α-agonists (clonidine)
• myocardial infarction or cerebrovascular accident within the past six months
• uncontrolled hypertension (BP\>170/100 mm Hg)
• low BP\<100/50 mm Hg
• surgery within the past 3 months

Sponsors & Collaborators

• Emory University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Emory Clinic

Atlanta, Georgia, 30322, United States

RECRUITING

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Sodium Bicarbonate; Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jeanie Park, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana DaCosta

CONTACT

404-727-7762; drdacos@emory.edu

Jeanie Park, MD

CONTACT

404-321-6111

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 25, 2023
• First Posted: July 3, 2023
• Study Start: November 11, 2022
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available for sharing after the results from this study have been published.
• Access Criteria: Data will be made available for sharing with researchers who provide a methodologically sound proposal, in order to achieve the aims in the approved proposal. Proposals should be directed to jeanie.park@emory.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (2)