Heart Failure With Preserved Ejection FractionSAUNA-HFpEFNCT06978868
Effects of Sauna on Cardiac and Skeletal Muscle Function in Patients With HFpEF (SAUNA-HFpEF)
A study testing Sauna Intervention in Clinically Stable Outpatients with HFpEF in people with Heart Failure With Preserved Ejection Fraction, run by Otto-von-Guericke University Magdeburg at 1 site in Germany.
Trial summary
Heart failure with preserved ejection fraction (HFpEF) is a type of heart failure where the heart pumps normally but patients still experience symptoms like fatigue, shortness of breath, and reduced ability to exercise. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Sauna Intervention in Clinically Stable Outpatients with HFpEF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- 19 Oct 2023to 16 Aug 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NYHA class II or III, clinically stable in the previous three months
- Females and males, age >50 years
- Left ventricular EF >50%, and at least 2 of the following: left atrial volume index (LAVI ≥34ml/m2) or E/e' >9 or interventricular septal thickness >12mm or pulmonary arterial pressure >35mmHg (noninvasive measurement) for HFpEF as recommended according to the ESC-HF-guidelines.
- Stable on standard HF medication according to the ESC-HF guidelines in the last 4 weeks
Who cannot join
- Major cardiovascular event or procedure such as myocardial infarction, percutaneous coronary intervention (PCI), aortocoronary bypass operation in the previous 3 months.
- Patients who have an indication for dual platelet inhibition
- Stroke
- Patients with mechanical heart valves or implanted cardiac devices
- Pulmonary embolism or deep vein thrombosis
- Patients with altered or reduced sweat function, such as in autoimmune diseases, spinal cord injuries or Fabry disease
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- Symptomatic hypotension regardless of the measured value and those with BP systolic <110 mm Hg
- Patients on oral anticoagulation for other reasons than atrial fibrillation
- Uncontrolled diabetes mellitus (HbA1c>8%), severe renal dysfunction, GFR<30ml/min) or pulmonary disease (COPD GOLD ≥3)
- Primary muscle disorder (e.g., muscular dystrophies)
- Neurological disease (e.g., Dementia or Parkinson syndrome)
- Right ventricular dysfunction or uncontrolled arrhythmias
- Any condition that in the opinion of the investigator could prohibit performance of 6MWT
Trial locations and contacts
1 site in 1 country.
Germany1 site
Otto von Guericke University, Faculty of Medicine
Magdeburg, Saxony-Anhalt, 39120
About this study
Official title: The Effect of Sauna on Cardiac and Skeletal Muscle Function in Patients With HFpEF (SAUNA-HFpEF): A Mechanistic, Pilot Prospective, Single-arm, Single Centre Study
Heart failure with preserved ejection fraction (HFpEF) is a type of heart failure where the heart pumps normally but patients still experience symptoms like fatigue, shortness of breath, and reduced ability to exercise. Many patients with HFpEF also have muscle weakness and limited mobility, which makes it difficult to follow traditional exercise programs like running or cycling. While there have been improvements in treating other types of heart failure, finding effective options for this specific form remains a challenge.
This study will explore whether bio-sauna bathing-a form of mild heat therapy-can help improve muscle function and exercise ability in patients with HFpEF. Sauna therapy might offer similar benefits to light exercise and could be easier and safer for older patients or those who can't do intense physical activity. The goal of this study is to evaluate whether regular sauna sessions is safe in patients with HFpEF and if it can improve exercise capacity, reduce shortness of breath, and support muscle health in patients with HFpEF.
Read the detailed description
The aim of the study is to test the safety and efficacy of intermittent hyperthermia (sauna) in a pilot study on patients with HfpEF regarding cardiac function, exercise capacity, skeletal muscle structure and function, metabolomic changes, and quality of life both at baseline and after the intervention with sauna.
Hypothesis: It was hypothesized that intermittent hyperthermia (sauna) is a feasible intervention in patients with HFpEF. Explorative, the effect of the intervention on filling pressure (E/é) as well as on the level of NT-pro-BNP, will be tested. Peripherally, skeletal muscle function (including metabolic and mitochondrial function) and structure. Finally, the effects of the intervention on QoL will be tested.
Questions to be answered through our investigation,
- Is hyperthermia intervention (sauna) feasible in patients with HF?
- Does sauna improve exercise capacity? (CPET, 6MWT, skeletal muscle strength and endurance).
- Does sauna improve cardiac function (Echocardiography).
- Understanding the related pathophysiology of the observed results on skeletal muscle and exercise capacity on molecular and mitochondrial level (skeletal muscle biopsies and the following tissue analysis parallel to blood analysis).
- The role of inflammation in the altered muscle structure and function and its possible reversibility through sauna.
- Observing changes in QoL and mental health (depression and anxiety).
The results of this study will be supportive in planning the randomised controlled clinical trial.
The intervention was twice weekly for a period of 10 weeks. : All participants will undergo a standardized series of assessments such as echocardiogram, CPET, 6-MWT, muscle strength measurements, and skeletal muscle biopsies. In case of clinical improvement, these benefits are likely to diminish over time if sauna bathing is discontinued. To address this, patients will be invited for a follow-up visit three months after completing the intervention. All investigations will be repeated, except for the skeletal muscle biopsy.
- Being tested
- Sauna Intervention in Clinically Stable Outpatients with HFpEF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sauna Intervention in Clinically Stable Outpatients with HFpEFOther
Patients were accompanied by study physicians for two sessions weekly, each between 8-15 minutes. We started the first 2 weeks with 8 minutes. Week 3-4: 10 minutes, week 5-6: 12 minutes, week 7-10: 12-15 minutes. Patients were given the freedom to leave the sauna session at any time if they experienced discomfort or were unable to tolerate it. Sessions were done in groups of 5 patients of men or women. The temperature of the sauna was 60°C. After each session, patients were asked to shower with moderate temperature of water and then rest for 20 minutes. Blood pressure and heart rate were measured prior to each session as well as directly after the sauna session and at the end of the rest time.
| Study group | Role | What they receive |
|---|---|---|
| Clinically stable outpatients with HFpEF | Experimental | All participants will be accompanied by medical doctors for two sessions weekly, each between 8-15 minutes. The intervention will be done in the NEMO-sauna in Magdeburg. The duration of the intervention will be 10 weeks. We will start the first 2 weeks with 8 minutes. Week 3-4: 10 minutes, week 5-6: 12 minutes, week 7-10: 12-15 minutes. Sessions will be done in groups each consisting of 5 patients. The temperature of the sauna will be 60°C. After each session a cold shower will follow and then rest for 20 minutes. Blood pressure, heart frequency, O2-Saturation will be measured prior to each session as well as directly after the shower and at the end of the rest. Receives: Other: Sauna Intervention in Clinically Stable Outpatients with HFpEF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity
The clinical effect of sauna on peak VO2 (ml/min)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start19 Oct 2023
- Primary completion2 May 2024
- Study completion16 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otto-von-Guericke University Magdeburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Bekfani, Otto-von-Guericke University Magdeburg
- Investigators
- Tarek Bekfani, MD, MSc, Principal investigator, University Hospital Magdeburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978868
- Sponsor's protocol ID
- 61/23
- Acronym
- SAUNA-HFpEF
- Status last verified
- May 2025
- First submitted
- 17 Apr 2025
- Last updated
- 18 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sauna on Cardiac and Skeletal Muscle Function in Patients With HFpEF (SAUNA-HFpEF): A Mechanistic, Pilot Prospective, Single-arm, Single Centre Study
- ClinicalTrials.gov ID
- NCT06978868
- Acronym / sponsor ID
- SAUNA-HFpEF / 61/23
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Otto-von-Guericke University MagdeburgUniversity, hospital or other
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 16 Aug 2024 (actual)
- First posted
- 18 May 2025 (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.
Heart failure with preserved ejection fraction (HFpEF) is a type of heart failure where the heart pumps normally but patients still experience symptoms like fatigue, shortness of breath, and reduced ability to exercise. Many patients with HFpEF also have muscle weakness and limited mobility, which makes it difficult to follow traditional exercise programs like running or cycling. While there have been improvements in treating other types of heart failure, finding effective options for this specific form remains a challenge.
This study will explore whether bio-sauna bathing-a form of mild heat therapy-can help improve muscle function and exercise ability in patients with HFpEF. Sauna therapy might offer similar benefits to light exercise and could be easier and safer for older patients or those who can't do intense physical activity. The goal of this study is to evaluate whether regular sauna sessions is safe in patients with HFpEF and if it can improve exercise capacity, reduce shortness of breath, and support muscle health in patients with HFpEF.
Detailed description
The aim of the study is to test the safety and efficacy of intermittent hyperthermia (sauna) in a pilot study on patients with HfpEF regarding cardiac function, exercise capacity, skeletal muscle structure and function, metabolomic changes, and quality of life both at baseline and after the intervention with sauna.
Hypothesis: It was hypothesized that intermittent hyperthermia (sauna) is a feasible intervention in patients with HFpEF. Explorative, the effect of the intervention on filling pressure (E/é) as well as on the level of NT-pro-BNP, will be tested. Peripherally, skeletal muscle function (including metabolic and mitochondrial function) and structure. Finally, the effects of the intervention on QoL will be tested.
Questions to be answered through our investigation,
- Is hyperthermia intervention (sauna) feasible in patients with HF?
- Does sauna improve exercise capacity? (CPET, 6MWT, skeletal muscle strength and endurance).
- Does sauna improve cardiac function (Echocardiography).
- Understanding the related pathophysiology of the observed results on skeletal muscle and exercise capacity on molecular and mitochondrial level (skeletal muscle biopsies and the following tissue analysis parallel to blood analysis).
- The role of inflammation in the altered muscle structure and function and its possible reversibility through sauna.
- Observing changes in QoL and mental health (depression and anxiety).
The results of this study will be supportive in planning the randomised controlled clinical trial.
The intervention was twice weekly for a period of 10 weeks. : All participants will undergo a standardized series of assessments such as echocardiogram, CPET, 6-MWT, muscle strength measurements, and skeletal muscle biopsies. In case of clinical improvement, these benefits are likely to diminish over time if sauna bathing is discontinued. To address this, patients will be invited for a follow-up visit three months after completing the intervention. All investigations will be repeated, except for the skeletal muscle biopsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinically stable outpatients with HFpEF | Experimental | Other: Sauna Intervention in Clinically Stable Outpatients with HFpEFAll participants will be accompanied by medical doctors for two sessions weekly, each between 8-15 minutes. The intervention will be done in the NEMO-sauna in Magdeburg. The duration of the intervention will be 10 weeks. We will start the first 2 weeks with 8 minutes. Week 3-4: 10 minutes, week 5-6: 12 minutes, week 7-10: 12-15 minutes. Sessions will be done in groups each consisting of 5 patients. The temperature of the sauna will be 60°C. After each session a cold shower will follow and then rest for 20 minutes. Blood pressure, heart frequency, O2-Saturation will be measured prior to each session as well as directly after the shower and at the end of the rest. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- NYHA class II or III, clinically stable in the previous three months
- Females and males, age >50 years
- Left ventricular EF >50%, and at least 2 of the following: left atrial volume index (LAVI ≥34ml/m2) or E/e' >9 or interventricular septal thickness >12mm or pulmonary arterial pressure >35mmHg (noninvasive measurement) for HFpEF as recommended according to the ESC-HF-guidelines.
- Stable on standard HF medication according to the ESC-HF guidelines in the last 4 weeks
Key exclusion criteria (13 listed)
- Major cardiovascular event or procedure such as myocardial infarction, percutaneous coronary intervention (PCI), aortocoronary bypass operation in the previous 3 months.
- Patients who have an indication for dual platelet inhibition
- Stroke
- Patients with mechanical heart valves or implanted cardiac devices
- Pulmonary embolism or deep vein thrombosis
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 |
|---|---|---|
| Sauna Intervention in Clinically Stable Outpatients with HFpEFPatients were accompanied by study physicians for two sessions weekly, each between 8-15 minutes. We started the first 2 weeks with 8 minutes. Week 3-4: 10 minutes, week 5-6: 12 minutes, week 7-10: 12-15 minutes. Patients were given the freedom to leave the sauna session at any time if they experienced discomfort or were unable to tolerate it. Sessions were done in groups of 5 patients of men or women. The temperature of the sauna was 60°C. After each session, patients were asked to shower with moderate temperature of water and then rest for 20 minutes. Blood pressure and heart rate were measured prior to each session as well as directly after the sauna session and at the end of the rest time. | Other | Clinically stable outpatients with HFpEF |
Primary outcome
Exercise capacity
Time frame: 10 weeks
The clinical effect of sauna on peak VO2 (ml/min)
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 18 May 2025.
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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.
Tarek Bekfani, MD, MSc principal investigator
University Hospital Magdeburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sauna Intervention in Clinically Stable Outpatients with HFpEF in people with Heart Failure With Preserved Ejection Fraction, run by Otto-von-Guericke University Magdeburg at 1 site in Germany.
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 4 inclusion and 13 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 18 May 2025. 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 Germany. 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?
Exercise capacity (time frame: 10 weeks). 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 18 May 2025.