NCT06978868Completed
Effects of Sauna on Cardiac and Skeletal Muscle Function in Patients With HFpEF (SAUNA-HFpEF)
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
Source: ClinicalTrials.gov · Last updated 18 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 18 (actual)
- First submitted
- 17 Apr 2025
- Start date
- 19 Oct 2023
- Primary completion date
- 2 May 2024
- Lead sponsor
- Otto-von-Guericke University Magdeburg
- Diseases
- Heart failure
- NCT number
- NCT06978868
What you commit to
- Study type: Interventional
- Participants enrolled: 18
- From 19 Oct 2023 to the primary completion date, 2 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major cardiovascular event or procedure such as myocardial infarction, percutaneous coronary intervention (PCI), aortocoronary bypass operation in the previous 3 months.
Other illness
- 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
- 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
Lab values
- Patients who have an indication for dual platelet inhibition
- Uncontrolled diabetes mellitus (HbA1c\>8%), severe renal dysfunction, GFR\<30ml/min) or pulmonary disease (COPD GOLD ≥3)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Otto von Guericke University, Faculty of Medicine Coordinator of this site? Confirm its status | Magdeburg | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.