Effects of Sauna on Cardiac and Skeletal Muscle Function in Patients With HFpEF (SAUNA-HFpEF)

NCT06978868 | Completed

• 1 other identifier: 61/23
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• Exercise capacity

  The clinical effect of sauna on peak VO2 (ml/min)

  10 weeks

Study Arms (1)

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.

Other: Sauna Intervention in Clinically Stable Outpatients with HFpEF

Interventions

Sauna Intervention in Clinically Stable Outpatients with HFpEF OTHER

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.

Clinically stable outpatients with HFpEF

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Otto-von-Guericke University Magdeburg: lead

Study Sites (1)

Otto von Guericke University, Faculty of Medicine

Magdeburg, Saxony-Anhalt, 39120, Germany

Location

Study Officials

• Tarek Bekfani, MD, MSc

  University Hospital Magdeburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Tarek Bekfani, MD, MSc (Oxon.), FESC, FHFA

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: May 18, 2025
• Study Start: October 19, 2023
• Primary Completion: May 2, 2024
• Study Completion: August 16, 2024
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

DE (1)