Renal Insufficiency, ChronicNCT05924919
The Effects of Passive Heat Therapy in Patients With Chronic Kidney Disease
A study testing Whole-body Passive Heat Therapy (HT) in people with Renal Insufficiency, Chronic, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The objective of this proposal is to investigate the acute effects of whole-body passive heat therapy using far-infrared technology on vascular function, exercise capacity, and renal function in CKD patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- Whole-body Passive Heat Therapy (HT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2023to 19 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Stage 2-4 CKD
Who cannot join
- Unstable medical conditions characterized by frequent or unpredictable biological, chemical, or psychological changes
- Uncontrolled hypertension
- Current fluid restrictions
- End stage kidney disease or currently on dialysis treatment
- Body weight < 40kg
- Exhibits any contraindications to exercise as per ACSM guidelines
Show all 18Show fewer
- Regular tobacco and/or nicotine use
- History of heat-related illness
- Participates in regular exercise and/or sauna use
- Current hormone replacement therapy
- Pacemaker or electro-medical implant
- Persons with or at risk of intestinal disorders including gastroporesis
- History of diverticula
- Persons who have undergone surgical procedures in the GI tract
- Swallowing disorders
- Chron's disease
- Current pregnancy
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23220
About this study
The objective of this proposal is to investigate the acute effects of whole-body passive heat therapy using far-infrared technology on vascular function, exercise capacity, and renal function in CKD patients. The central hypothesis is that an acute bout of whole-body passive heat therapy will be well-tolerated and lead to acute improvements in large blood vessel (macrovascular) function, small blood vessel (microvascular) function, and exercise capacity without significantly altering markers of acute kidney injury.
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- Whole-body Passive Heat Therapy (HT), Thermoneutral Control (CON)
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-body Passive Heat Therapy (HT)Procedure or surgery
The whole-body passive heat therapy (HT) intervention will consist of an acute bout of infrared sauna for 25 minutes at 60°C. Participants will lie supine on a memory foam pad.
Thermoneutral Control (CON)Procedure or surgery
Participants will remain in a room temperature environment (22°C) underneath the infrared domes for 25 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm: Whole-body Passive Heat Therapy (HT) | Experimental | Heat therapy will be administered using an infrared sauna. The intervention duration will last 25 minutes at a temperature of 60°C. Receives: Procedure: Whole-body Passive Heat Therapy (HT); Procedure: Thermoneutral Control (CON) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Safety of Heat Therapy
Change in urinary NGAL
Measured: Change from baseline to 90 minutes after intervention
Tolerability of Heat Therapy as Assessed using Validated Questionnaires of Thermal Perception
Self reported perception of heat using the the Thermal Sensation Scale.
Measured: During 25 minute intervention
Secondary outcomes (3)
Conduit artery endothelial function
Brachial artery flow-mediated dilation assessed by high-resolution duplex ultrasound.
Measured: 90 minutes after intervention
Lower Limb Microvascular Function
Lower limb microvascular function will be assessed with high-resolution duplex ultrasound during passive leg movement (PLM) technique.
Measured: 90 minutes after intervention
Exercise Capacity
The 6-minute walk test distance.
Measured: 90 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start18 Sep 2023
- Primary completion19 Mar 2024
- Study completion19 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danielle Kirkman, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924919
- Sponsor's protocol ID
- HM20024906
- Other IDs
- 22-01741
- Status last verified
- Oct 2024
- First submitted
- 25 May 2023
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chavez DA, Garten RS, Rodriguez-Miguelez P, Kim Y, Gagnon D, Romero SA, Kidd JM, Kirkman DL. Acute effects of passive heat exposure on vascular function and exercise capacity in patients with chronic kidney disease. Am J Physiol Heart Circ Physiol. 2026 Jun 1;330(6):H2001-H2013. doi: 10.1152/ajpheart.00020.2026. Epub 2026 May 11.
PubMed 42113470
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Passive Heat Therapy in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05924919
- Acronym / sponsor ID
- HM20024906
- Conditions
- Renal Insufficiency, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 19 Mar 2024 (actual)
- Study completion
- 19 Mar 2024 (actual)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this proposal is to investigate the acute effects of whole-body passive heat therapy using far-infrared technology on vascular function, exercise capacity, and renal function in CKD patients. The central hypothesis is that an acute bout of whole-body passive heat therapy will be well-tolerated and lead to acute improvements in large blood vessel (macrovascular) function, small blood vessel (microvascular) function, and exercise capacity without significantly altering markers of acute kidney injury.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm: Whole-body Passive Heat Therapy (HT) | Experimental | Procedure: Whole-body Passive Heat Therapy (HT), Procedure: Thermoneutral Control (CON)Heat therapy will be administered using an infrared sauna. The intervention duration will last 25 minutes at a temperature of 60°C. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years old
- Stage 2-4 CKD
Key exclusion criteria (18 listed)
- Unstable medical conditions characterized by frequent or unpredictable biological, chemical, or psychological changes
- Uncontrolled hypertension
- Current fluid restrictions
- End stage kidney disease or currently on dialysis treatment
- Body weight < 40kg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-body Passive Heat Therapy (HT)The whole-body passive heat therapy (HT) intervention will consist of an acute bout of infrared sauna for 25 minutes at 60°C. Participants will lie supine on a memory foam pad. | Procedure or surgery | Experimental Arm: Whole-body Passive Heat Therapy (HT) |
| Thermoneutral Control (CON)Participants will remain in a room temperature environment (22°C) underneath the infrared domes for 25 minutes. | Procedure or surgery | Experimental Arm: Whole-body Passive Heat Therapy (HT) |
Primary outcome
Renal Safety of Heat Therapy
Time frame: Change from baseline to 90 minutes after intervention
Change in urinary NGAL
Tolerability of Heat Therapy as Assessed using Validated Questionnaires of Thermal Perception
Time frame: During 25 minute intervention
Self reported perception of heat using the the Thermal Sensation Scale.
3 secondary outcomes
Conduit artery endothelial function
Time frame: 90 minutes after intervention
Lower Limb Microvascular Function
Time frame: 90 minutes after intervention
Exercise Capacity
Time frame: 90 minutes after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Derived from this study: PubMed 42113470Chavez DA, Garten RS, Rodriguez-Miguelez P, Kim Y, Gagnon D, Romero SA, Kidd JM, Kirkman DL. Acute effects of passive heat exposure on vascular function and exercise capacity in patients with chronic kidney disease. Am J Physiol Heart Circ Physiol. 2026 Jun 1;330(6):H2001-H2013. doi: 10.1152/ajpheart.00020.2026. Epub 2026 May 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle Kirkman, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-body Passive Heat Therapy (HT) in people with Renal Insufficiency, Chronic, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal Safety of Heat Therapy (time frame: Change from baseline to 90 minutes after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05924919, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.