Evaluation of the Effects of Sauna Therapy on Congestion and Loop Diuretic Use in Patients With Heart Failure With Reduced or Moderately Reduced Ejection Fraction

NCT07468344 | Not Yet Recruiting DMC

• 1 other identifier: 2025-A02089-40
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of sauna therapy on congestion levels during cardiac rehabilitation in patients with heart failure who have an impaired or moderately impaired ejection fraction, compared to standard cardiac rehabilitation care. To investigate this, patients with reduced cardiac function who are hospitalized as part of a cardiac rehabilitation program will be included. These patients will be randomly assigned to two groups: standard cardiac rehabilitation program (control group) and sauna group (intervention group). The study will also assess whether this approach could allow for a reduction in the dose of diuretics, which are commonly used to remove excess fluid, thereby helping to avoid certain side effects. The expected benefits include a reduction in symptoms such as shortness of breath and swelling, improvements in quality of life and physical fitness, and enhanced blood vessel function.

Conditions

Heart Failure

Keywords

congestion; sauna; heart failure

Outcome Measures

Primary Outcomes (1)

• Median change in NT-proBNP levels.

  Between randomization and the end of the third week.

Secondary Outcomes (34)

• Daily dose of loop diuretics.

  Day 1, end of weeks 1, 2, and 3, and 3-month follow-up.

• Weight in kilograms.

  Day 1, end of weeks 1,2 and 3, and 3-month follow-up.

• Congestion score: ADVoR congestion score.

  Day 1, end of week 3, and 3-month follow-up.

• Congestion score: Ambrosy congestion score.

  Day 1, end of week 3, and 3-month follow-up.

• Estimated plasma volume (EPV): Duarte formula.

  Day 1, end of week 3, and 3-month follow-up.

Study Arms (2)

Sauna

EXPERIMENTAL

A 15-minute sauna session at 60 degrees Celsius during hospitalization for cardiac rehabilitation.

Device: Sauna

Control

NO INTERVENTION

Usual care as part of a day hospital stay for cardiac rehabilitation.

Interventions

Sauna DEVICE

A 15-minute sauna session at 60 degrees Celsius, five times a week for three weeks during hospitalization for cardiac rehabilitation. The sauna sessions will be followed by 30 minutes of recovery in a seated position. In addition to the sauna, patients will benefit from cardiac rehabilitation care for 3 weeks.

Sauna

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years.
• Heart failure with ejection fraction \<50% confirmed by an echocardiogram within the past year.
• NYHA class II-III.
• Loop diuretic dose ≥ 40 mg/day of furosemide (or equivalent) for at least 30 days.
• NT-proBNP \> 400 pg/ml or BNP \> 100 pg/ml.
• Systolic blood pressure ≥ 100 mmHg.
• Estimated glomerular filtration rate (eGFR) ≥ 20 ml/min/1.73 m².
• Patient scheduled for a hospital-based cardiac rehabilitation program for a minimum of 3 weeks.
• Person who has undergone a preliminary clinical examination suitable for clinical research.
• Person affiliated with a social security system or a beneficiary of such a system.
• Person who has received complete information about the organization of the clinical research and has signed informed consent.

You may not qualify if:

• Person presenting a contraindication to sauna therapy (for example, intolerance to heat).
• Serum sodium \< 130 mmol/L.
• Serum potassium \> 5.5 mmol/L.
• Active infection, liver disease, or peripheral vascular disease.
• Acute coronary syndrome or recent stroke (\<90 days).
• Participation in another interventional clinical trial.
• Person subject to Articles L. 1121-5, L. 1121-7, and L. 1121-8 of the Public Health Code (applicable in France) :- pregnant, giving birth, or breastfeeding woman , minor (non-emancipated), person adult subject to a legal protection measure (guardianship, curatorship, judicial protection) , adult unable to express consent, persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care under Articles L. 3212-1 and L. 3213-1…

Sponsors & Collaborators

• BAUDRY Guillaume: lead

Study Sites (1)

Centre Hospitalier Régional Universitaire de Nancy

Nancy, France

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Steam Bath

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Balneology; Therapeutics; Hyperthermia, Induced

Central Study Contacts

Guillaume Baudry

CONTACT

+33 03 83 15 73 22; g.baudry@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study chair

Model Details: All included patients will undergo a 15-minute sauna session prior to randomization in order to assess sauna tolerance. In case of intolerance to the sauna, the patient will not be randomized and will not continue to participate in the study.

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: March 12, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

FR (1)