An interventional study of Sauna Intervention in Clinically Stable Outpatients with HFpEF in Heart Failure With Preserved Ejection Fraction, sponsored by Otto-von-Guericke University Magdeburg. Completed at 1 site in Germany. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-05-18.
Sponsored by Otto-von-Guericke University Magdeburg · Not applicable, Interventional, and Treatment
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.
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,
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 18 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
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Exclusion criteria:
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.
Other: Sauna Intervention in Clinically Stable Outpatients with HFpEF
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.
Exercise capacity
The clinical effect of sauna on peak VO2 (ml/min)
Time frame: 10 weeks
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Otto-von-Guericke University Magdeburg