NCT07468344尚未招募不适用
Impact of Sauna Therapy on Congestion and Loop Diuretic Adjustment in Patients With Heart Failure
BAUDRY Guillaume1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2026年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Median change in NT-proBNP levels.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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…
研究组 & 干预措施
Sauna
Experimental
A 15-minute sauna session at 60 degrees Celsius during hospitalization for cardiac rehabilitation.
干预措施: Sauna (Device)
Control
No Intervention
Usual care as part of a day hospital stay for cardiac rehabilitation.
结局指标
主要结局
Median change in NT-proBNP levels.
时间窗: Between randomization and the end of the third week.
次要结局
- Heart rate variability in millisecond (ms).(Multiple daily measurements : 4 times a day, 5 days a week for 3 weeks.)
- Evaluation of renal function through renal function assessment.(Day 1 and end of week 3.)
- 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.)
- Dose of diuretics.(Day 1, end of weeks 1, 2, and 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.)
- Dyspnea visual analog scale: Cumulative dyspnea assessment (AUC).(Day 1, beginning of weeks 2 and 3.)
- Concentration of natriuretic peptides (NT-proBNP).(Day 1, end of week 1, beginning and end of week 2, beginning and end of week 3, and 3-month follow-up.)
- Heart rate in Beats Per Minute (BPM).(Multiple daily measurements : 4 times a day, 5 days a week for 3 weeks.)
- Evaluation of renal function through rate of serum creatinine allowing to estimate glomerular filtration rate.(End of weeks 1, 2, and 3 and 3-month follow-up.)
- Concentration of serum electrolytes (Cl-, Na+, K+).(Day 1, end of weeks 1, 2, and 3, and 3-month follow-up.)
- Blood osmolality in mmol/L.(Day 1, end of weeks 1, 2, and 3, and 3-month follow-up.)
- Concentration of urinary electrolytes (Cl-, Na+, K+).(Day 1, end of weeks 1, 2, and 3, and 3-month follow-up.)
- Urinary osmolality in mmol/L.(Day 1, beginning and end of weeks 1, 2, and 3, and 3-month follow-up.)
- Hemoconcentration biomarkers : Hct.(Day 1, end of weeks 1, 2, and 3, and 3-month follow-up.)
- Hemoconcentration biomarkers : Hb.(Day 1, end of weeks 1, 2, and 3, and 3-month follow-up.)
- Hemoconcentration biomarkers : total protein.(Time Frame: Day 1, end of weeks 1, 2, and 3, and 3-month follow-up.)
- Hemoconcentration biomarkers : copeptin.(Time Frame: Day 1, end of weeks 1, 2, and 3, and 3-month follow-up.)
- Inferior vena cava diameter (millimeters, mm) measured by transthoracic echocardiography during inspiration.(Day 1, end of week 1, beginning and end of week 2, beginning and end of week 3, and 3-month follow-up.)
- Monitoring of changes in pulmonary blood pressure.(Day 1 and at 3-month follow-up.)
- Inferior vena cava diameter (millimeters, mm) in expiration measured by transthoracic echocardiography during expiration.(Day 1, end of week 1, beginning and end of week 2, beginning and end of week 3, and 3-month follow-up.)
- Inferior vena cava respiratory variation / collapsibility index (percentage, %) assessed by transthoracic echocardiography.(Day 1, end of week 1, beginning and end of week 2, beginning and end of week 3, and 3-month follow-up.)
- Lung ultrasound score (8 points).(Day 1, end of week 3, and 3-month follow-up.)
- Quantification of changes in systolic and diastolic function.(Day 1 and 3-month follow-up.)
- Blood pressure in mmHg.(Up to 3 weeks and at 3-month follow-up.)
- Composite clinical endpoint of hospitalization or emergency visits for heart failure or all-cause death.(At 3-month follow-up.)
- Body composition parameters assessed by bioelectrical impedance analysis.(Day 1, end of Week 1, beginning and end of Week 2, beginning and end of Week 3, and at 3-month follow-up.)
- Specific to the sauna group : weight in kilograms.(Up to 3 weeks.)
- Specific to the sauna group : blood pressure in mmHg.(Up to 3 weeks.)
- Specific to the sauna group : temperature in °C.(Up to 3 weeks.)
- Specific to the sauna group : heart rate in Beats Per Minute (BPM).(Up to 3 weeks.)
- Specific to the sauna group : sodium chloride concentration in sweat.(Up to 3 weeks.)
研究者
BAUDRY Guillaume
Study chair
Central Hospital, Nancy, France
研究点 (1)
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