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

Официальное название

Impact of Sauna Therapy on Congestion and Loop Diuretic Adjustment in Patients With Heart Failure

Обзор

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.

Вмешательства

• Устройство Sauna
  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.

Первичные конечные точки

• Median change in NT-proBNP levels. [Срок оценки: Between randomization and the end of the third week.]

Вторичные конечные точки (12)

• Daily dose of loop diuretics. [Срок оценки: Day 1, end of weeks 1, 2, and 3, and 3-month follow-up.]
• Weight in kilograms. [Срок оценки: Day 1, end of weeks 1,2 and 3, and 3-month follow-up.]
• Congestion score: ADVoR congestion score. [Срок оценки: Day 1, end of week 3, and 3-month follow-up.]
• Congestion score: Ambrosy congestion score. [Срок оценки: Day 1, end of week 3, and 3-month follow-up.]
• Estimated plasma volume (EPV): Duarte formula. [Срок оценки: Day 1, end of week 3, and 3-month follow-up.]
• Dyspnea visual analog scale: Cumulative dyspnea assessment (AUC). [Срок оценки: Day 1, beginning of weeks 2 and 3.]
• Concentration of natriuretic peptides (NT-proBNP). [Срок оценки: Day 1, end of week 1, beginning and end of week 2, beginning and end of week 3, and 3-month follow-up.]
• Evaluation of renal function through rate of serum creatinine allowing to estimate glomerular filtration rate. [Срок оценки: End of weeks 1, 2, and 3 and 3-month follow-up.]
• Evaluation of renal function through renal function assessment. [Срок оценки: Day 1 and end of week 3.]
• Dose of diuretics. [Срок оценки: Day 1, end of weeks 1, 2, and 3, and 3-month follow-up.]
• Concentration of serum electrolytes (Cl-, Na+, K+). [Срок оценки: Day 1, end of weeks 1, 2, and 3, and 3-month follow-up.]
• Blood osmolality in mmol/L. [Срок оценки: Day 1, end of weeks 1, 2, and 3, and 3-month follow-up.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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…

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Centre Hospitalier Régional Universitaire de Nancy — Nancy

Идентификаторы

NCT: NCT07468344 · 2025-A02089-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗