Heart FailureNCT04026126
Effects of Passive Heat Therapy on Oxygen Consumption and Cardiovascular Fitness in Adults
A study testing Heat Therapy Treatment in people with Heart Failure and Heart Diseases, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if enhanced endothelial arterial distensibility observed with heat therapy translates into improved cardiorespiratory fitness. The following aims are proposed: Aim 1: to determine if chronic heat therapy results in improvements in cardiovascular function. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Heart Diseases, Cardiovascular Diseases
- What is being tested?
- Heat Therapy Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2019to 14 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Current major cardiovascular disease (i.e.: recent myocardial infarction (heart attack), stroke, angina pectoris, high grade coronary vasculopathy or atherosclerosis, severe valvular disease, cardiac dysrhythmia that requires treatment.
- Current treatment with steroids or immunosuppressive agents
- Cancer
- Serious liver disease
- End-stage renal disease
- Judgement by medical provider that heat therapy poses an undue burden or risk
- Women who are pregnant or plan to become pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The purpose of this study is to determine if enhanced endothelial arterial distensibility observed with heat therapy translates into improved cardiorespiratory fitness. The following aims are proposed: Aim 1: to determine if chronic heat therapy results in improvements in cardiovascular function. Aim 2: To examine potential mechanism(s) of action of heat therapy in cardiovascular function.
Read the detailed description
The National Institute of Health recognizes heart failure as a major public health problem with a prevalence of over 5.8 million Americans and 23 million people worldwide. Commonly prescribed medications to treat the symptoms associated with this disease are expensive and many are not covered by major health insurance companies. There is a critical need to develop novel treatment and prevention strategies for heart failure. Emerging research highlights the benefits of heat therapy (HT) on metabolic and cardiovascular disease risk. The Geiger laboratory has demonstrated that in obese rats fed a high- fat diet for 12 weeks, weekly HT restored whole body glucose tolerance and skeletal muscle insulin sensitivity. The first comprehensive investigation of long-term HT in young, sedentary humans resulted in improved endothelial function and hemodynamics that were on par with what is typically observed with exercise training in previously sedentary subjects. The purpose of this pilot study is to determine if the enhanced endothelial arterial distensibility observed with HT translates into improved cardiorespiratory fitness. The following aims are proposed:
Aim 1: To determine if chronic HT results in improvements in cardiovascular function. The study team hypothesizes that repeated HT will result in improvement in hemodynamic variables related to arterial distensibility (blood pressure, stroke volume, stroke volume variation, cardiac index and systemic vascular resistance) and that these changes translate to improved cardiovascular function as measured by VO2max.
Aim 2: To examine potential mechanism(s) of action of HT in cardiovascular function. The study team hypothesizes that HT may exerts its beneficial effects via the effect of heat shock proteins (HSPs) on Nitric Oxide (NO) bioavailability. This will be tested by measuring HSPs, NO mediators and inflammatory markers at baseline and post-intervention. There is rapidly growing interest in the use of HT as a global therapeutic approach and alternative or complementary therapy to exercise training for patients with chronic disease. Study findings would be clinically significant as both men and women with higher cardiorespiratory fitness (as indicated by maximal oxygen consumption, VO2max) are at lower risk for cardiovascular disease.
These studies will be the first to examine the ability of chronic heat therapy to increase cardiorespiratory fitness as measured by maximal oxygen consumption, VO2max. These findings could lead to HT as a simple and effective tool for improving cardiovascular health in a variety of populations, particularly those with exercise limitations and comorbid disease states like type 2 diabetes, dementia and cardiovascular disease.
- Being tested
- Heat Therapy Treatment
- Keywords
- Heat Therapy
- Medical subject headings
- Heart Failure, Heart Diseases, Cardiovascular Diseases, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat Therapy TreatmentBehavioural
Subjects will undergo 10 hot water immersions of 40.5 degrees Celsius for approximately 45 minutes per session over 14 days. Subjects will be immersed up to the shoulder until rectal temperature reacher 38.5 degrees Celsius (approximately 15-20 minutes). Subjects will then remain in the water bath submerged at waist level to maintain between 38.5 to 39.0 degrees Celsius for another 30 minutes. Following hot water immersion, subjects will be monitored for 10 minutes, or until temperature falls below 38.5 degrees Celsius.
| Study group | Role | What they receive |
|---|---|---|
| Heat Therapy Treatment | Experimental | This study will recruit subjects to participate in heat therapy treatment at the University of Kansas Medical Center (KUMC). After pre-screening, informed consent, and enrollment, all subjects will have baseline hemodynamic assessments as well as VO2max measurements. Subjects will complete 10 heat therapy treatments over the course of 14 days. Hemodynamics will be assessed with the use of the Clearsight© fingertip blood pressure cuff. Within 24-48 hours after the last heat therapy experience, hemodynamic assessments and VO2max will be performed. Blood samples will be collected pre- and post intervention and analyzed for levels of nitric oxide mediators, heat shock protein levels and pro-anti-inflammatory markers. Receives: Behavioral: Heat Therapy Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Pressure
Systolic and diastolic blood pressure will be monitored using the noninvasive Clearsight (Edward Lifesciences, Irvine, CA) monitor, which incorporates a disposable, single use fingertip cuff.
Measured: Blood pressure will be assessed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit). As a safety measure only, blood pressure will be monitored during every heat therapy treatment.
Change in Stroke Volume
Stroke volume will be monitored using the noninvasive Clearsight (Edward Lifesciences, Irvine, CA) monitor incorporates a disposable, single use fingertip cuff.
Measured: Stroke volume will be assessed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit).
Change in Stroke Volume Variation
Stroke volume variation will be monitored using the noninvasive Clearsight (Edward Lifesciences, Irvine, CA) monitor incorporates a disposable, single use fingertip cuff.
Measured: Stroke volume variation will be assessed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit).
Change in Cardiac Index
Cardiac index will be monitored using the noninvasive Clearsight (Edward Lifesciences, Irvine, CA) monitor incorporates a disposable, single use fingertip cuff.
Measured: Cardiac index will be assessed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit).
Change in Systemic Vascular Resistance
Systemic vascular resistance will be monitored using the noninvasive Clearsight (Edward Lifesciences, Irvine, CA) monitor incorporates a disposable, single use fingertip cuff.
Measured: Systemic vascular resistance will be assessed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit).
Change in Maximum Oxygen Consumption (VO2max)
Maximum oxygen consumption (VO2max) will be measured using the Bruce Ramp protocol. The Bruce Ramp protocol is a standardized treadmill exercise commonly used in clinical laboratories.
Measured: VO2max assessment will be performed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit).
Change in Concentration of Heat Shock Proteins
Serum levels of heat shock proteins (HSP72, HSP25) and the primary heat shock protein transcription factor (HSF1) will be assessed for change post heat therapy treatment.
Measured: Blood analyses will be performed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit).
Change in Concentration of Nitric Oxide
Nitric oxide (NO) bioavailability will be assessed for change post heat therapy treatment by measuring nitric oxide and endothelial nitric oxide synthase (eNOS).
Measured: Blood analyses will be performed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit).
Change in Concentration of Pro/Anti-inflammatory Markers
Pro/anti-inflammatory markers (IL1ra, IL-10, IL-8, IFN, and CRP) will be assessed for change post heat therapy treatment.
Measured: Blood analyses will be performed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start29 Aug 2019
- Primary completion14 Jul 2021
- Study completion14 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Paige Geiger, PhD, University of Kansas Medical Center
- Investigators
- Paige C Geiger, Ph.D., Principal investigator, University of Kansas Medical CenterBrigid Flynn, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026126
- Sponsor's protocol ID
- STUDY00142890
- Other IDs
- P20GM103418-19
- Status last verified
- Oct 2022
- First submitted
- 26 Jun 2019
- Last updated
- 17 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Passive Heat Therapy on Oxygen Consumption and Cardiovascular Fitness in Adults
- ClinicalTrials.gov ID
- NCT04026126
- Acronym / sponsor ID
- STUDY00142890
- Keywords
- Heat Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 29 Aug 2019 (actual)
- Primary completion
- 14 Jul 2021 (actual)
- Study completion
- 14 Jul 2021 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Posted 17 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if enhanced endothelial arterial distensibility observed with heat therapy translates into improved cardiorespiratory fitness. The following aims are proposed: Aim 1: to determine if chronic heat therapy results in improvements in cardiovascular function. Aim 2: To examine potential mechanism(s) of action of heat therapy in cardiovascular function.
Detailed description
The National Institute of Health recognizes heart failure as a major public health problem with a prevalence of over 5.8 million Americans and 23 million people worldwide. Commonly prescribed medications to treat the symptoms associated with this disease are expensive and many are not covered by major health insurance companies. There is a critical need to develop novel treatment and prevention strategies for heart failure. Emerging research highlights the benefits of heat therapy (HT) on metabolic and cardiovascular disease risk. The Geiger laboratory has demonstrated that in obese rats fed a high- fat diet for 12 weeks, weekly HT restored whole body glucose tolerance and skeletal muscle insulin sensitivity. The first comprehensive investigation of long-term HT in young, sedentary humans resulted in improved endothelial function and hemodynamics that were on par with what is typically observed with exercise training in previously sedentary subjects. The purpose of this pilot study is to determine if the enhanced endothelial arterial distensibility observed with HT translates into improved cardiorespiratory fitness. The following aims are proposed:
Aim 1: To determine if chronic HT results in improvements in cardiovascular function. The study team hypothesizes that repeated HT will result in improvement in hemodynamic variables related to arterial distensibility (blood pressure, stroke volume, stroke volume variation, cardiac index and systemic vascular resistance) and that these changes translate to improved cardiovascular function as measured by VO2max.
Aim 2: To examine potential mechanism(s) of action of HT in cardiovascular function. The study team hypothesizes that HT may exerts its beneficial effects via the effect of heat shock proteins (HSPs) on Nitric Oxide (NO) bioavailability. This will be tested by measuring HSPs, NO mediators and inflammatory markers at baseline and post-intervention. There is rapidly growing interest in the use of HT as a global therapeutic approach and alternative or complementary therapy to exercise training for patients with chronic disease. Study findings would be clinically significant as both men and women with higher cardiorespiratory fitness (as indicated by maximal oxygen consumption, VO2max) are at lower risk for cardiovascular disease.
These studies will be the first to examine the ability of chronic heat therapy to increase cardiorespiratory fitness as measured by maximal oxygen consumption, VO2max. These findings could lead to HT as a simple and effective tool for improving cardiovascular health in a variety of populations, particularly those with exercise limitations and comorbid disease states like type 2 diabetes, dementia and cardiovascular disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heat Therapy Treatment | Experimental | Behavioral: Heat Therapy TreatmentThis study will recruit subjects to participate in heat therapy treatment at the University of Kansas Medical Center (KUMC). After pre-screening, informed consent, and enrollment, all subjects will have baseline hemodynamic assessments as well as VO2max measurements. Subjects will complete 10 heat therapy treatments over the course of 14 days. Hemodynamics will be assessed with the use of the Clearsight© fingertip blood pressure cuff. Within 24-48 hours after the last heat therapy experience, hemodynamic assessments and VO2max will be performed. Blood samples will be collected pre- and post intervention and analyzed for levels of nitric oxide mediators, heat shock protein levels and pro-anti-inflammatory markers. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Current major cardiovascular disease (i.e.: recent myocardial infarction (heart attack), stroke, angina pectoris, high grade coronary vasculopathy or atherosclerosis, severe valvular disease, cardiac dysrhythmia that requires treatment.
- Current treatment with steroids or immunosuppressive agents
- Cancer
- Serious liver disease
- End-stage renal disease
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 |
|---|---|---|
| Heat Therapy TreatmentSubjects will undergo 10 hot water immersions of 40.5 degrees Celsius for approximately 45 minutes per session over 14 days. Subjects will be immersed up to the shoulder until rectal temperature reacher 38.5 degrees Celsius (approximately 15-20 minutes). Subjects will then remain in the water bath submerged at waist level to maintain between 38.5 to 39.0 degrees Celsius for another 30 minutes. Following hot water immersion, subjects will be monitored for 10 minutes, or until temperature falls below 38.5 degrees Celsius. | Behavioural | Heat Therapy Treatment |
Primary outcome
Change in Blood Pressure
Time frame: Blood pressure will be assessed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit). As a safety measure only, blood pressure will be monitored during every heat therapy treatment.
Systolic and diastolic blood pressure will be monitored using the noninvasive Clearsight (Edward Lifesciences, Irvine, CA) monitor, which incorporates a disposable, single use fingertip cuff.
Change in Stroke Volume
Time frame: Stroke volume will be assessed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit).
Stroke volume will be monitored using the noninvasive Clearsight (Edward Lifesciences, Irvine, CA) monitor incorporates a disposable, single use fingertip cuff.
Change in Stroke Volume Variation
Time frame: Stroke volume variation will be assessed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit).
Stroke volume variation will be monitored using the noninvasive Clearsight (Edward Lifesciences, Irvine, CA) monitor incorporates a disposable, single use fingertip cuff.
Change in Cardiac Index
Time frame: Cardiac index will be assessed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit).
Cardiac index will be monitored using the noninvasive Clearsight (Edward Lifesciences, Irvine, CA) monitor incorporates a disposable, single use fingertip cuff.
Change in Systemic Vascular Resistance
Time frame: Systemic vascular resistance will be assessed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit).
Systemic vascular resistance will be monitored using the noninvasive Clearsight (Edward Lifesciences, Irvine, CA) monitor incorporates a disposable, single use fingertip cuff.
Change in Maximum Oxygen Consumption (VO2max)
Time frame: VO2max assessment will be performed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit).
Maximum oxygen consumption (VO2max) will be measured using the Bruce Ramp protocol. The Bruce Ramp protocol is a standardized treadmill exercise commonly used in clinical laboratories.
Change in Concentration of Heat Shock Proteins
Time frame: Blood analyses will be performed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit).
Serum levels of heat shock proteins (HSP72, HSP25) and the primary heat shock protein transcription factor (HSF1) will be assessed for change post heat therapy treatment.
Change in Concentration of Nitric Oxide
Time frame: Blood analyses will be performed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit).
Nitric oxide (NO) bioavailability will be assessed for change post heat therapy treatment by measuring nitric oxide and endothelial nitric oxide synthase (eNOS).
Change in Concentration of Pro/Anti-inflammatory Markers
Time frame: Blood analyses will be performed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit).
Pro/anti-inflammatory markers (IL1ra, IL-10, IL-8, IFN, and CRP) will be assessed for change post heat therapy treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Paige C Geiger, Ph.D. principal investigator
University of Kansas Medical Center
Brigid Flynn, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heat Therapy Treatment in people with Heart Failure and Heart Diseases, run by University of Kansas Medical Center 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 0 inclusion and 7 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 17 Oct 2022. 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?
Yes. Results are posted in the registry (first posted 17 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Blood Pressure (time frame: Blood pressure will be assessed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit). As a safety measure only, blood pressure will be monitored during every heat therapy treatment.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2022.