Status:
COMPLETED
Effects of Sauna on Cardiac and Skeletal Muscle Function in Patients With HFpEF (SAUNA-HFpEF)
Lead Sponsor:
Otto-von-Guericke University Magdeburg
Conditions:
Heart Failure With Preserved Ejection Fraction
Eligibility:
All Genders
50+ years
Phase:
NA
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 a...
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 stru...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
October 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06978868
Start Date
October 19 2023
End Date
August 16 2024
Last Update
May 18 2025
Active Locations (1)
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1
Otto von Guericke University, Faculty of Medicine
Magdeburg, Saxony-Anhalt, Germany, 39120