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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sauna | Experimental | A 15-minute sauna session at 60 degrees Celsius during hospitalization for cardiac rehabilitation. |
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| Control | No Intervention | Usual care as part of a day hospital stay for cardiac rehabilitation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Median change in NT-proBNP levels. | Between randomization and the end of the third week. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guillaume Baudry | Contact | +33 03 83 15 73 22 | g.baudry@chru-nancy.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Régional Universitaire de Nancy | Nancy | France |
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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.
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|
| Congestion score: ADVoR congestion score. |
ADVoR congestion score is a grading scale taking account oedema, pleural effusion and ascites. The score can range from 0 to 10 with "0" being the best result meaning " no congestion " and "10" the worst meaning " maximum congestion ". |
| Day 1, end of week 3, and 3-month follow-up. |
| Congestion score: Ambrosy congestion score. | Ambrosy congestion score is a grading scale taking account dyspnoea, orthopnoea, jugular venous distension, rales and oedema. The score can range from 0 to 18, "0" being the best outcome (no congestion) and "18" the worst outcome (maximum congestion). | 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). | The minimum value is "0" (best outcome) and means "no dyspnea". The maximum value is "10" (worst outcome) and means "maximum dyspnea". | 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. |
| Evaluation of renal function through rate of serum creatinine allowing to estimate glomerular filtration rate. | Estimate glomerular filtration rate is calculated by the following formula : Clearance (mL/min) = weight (kg) x (140-age) x K / serum creatinine (μmol/L) ; K=1.23 for man and 1.04 for woman. | End of weeks 1, 2, and 3 and 3-month follow-up. |
| Evaluation of renal function through renal function assessment. | Day 1 and end of week 3. |
| Dose of diuretics. | Day 1, 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. | Blood osmolality in mmol/L is calculated using natremia, glycemia and uremia. The formula is : Natremia in mmmol/L*2 + glycemia in mmol/L *5.56 + uremia in mmol/L*16.6. | 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. | Urinary osmolality in mmol/L is calculated using natremia, glycemia and uremia. The formula is : (natremia in mmol/L + kaliemia in mmol/L+ chloride in mmol/L) + (glycemia in mmol/L*5.56) + (uremia in mmol/L*16.6). | Day 1, beginning and end of weeks 1, 2, and 3, and 3-month follow-up. |
| Hemoconcentration biomarkers : Hct. | Hemoconcentration was assessed using hematocrit (%). | Day 1, end of weeks 1, 2, and 3, and 3-month follow-up. |
| Hemoconcentration biomarkers : Hb. | Hemoconcentration was assessed using hemoglobin (g/dL). | Day 1, end of weeks 1, 2, and 3, and 3-month follow-up. |
| Hemoconcentration biomarkers : total protein. | Hemoconcentration was assessed using total protein (g/L). | Time Frame: Day 1, end of weeks 1, 2, and 3, and 3-month follow-up. |
| Hemoconcentration biomarkers : copeptin. | Hemoconcentration was assessed using copeptin concentrations (pmol/L). | 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. | The inferior vena cava (IVC) diameter will be measured in millimeters using 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. |
| Inferior vena cava diameter (millimeters, mm) in expiration measured by transthoracic echocardiography during expiration. | IVC diameter will be measured in millimeters using 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. |
| Inferior vena cava respiratory variation / collapsibility index (percentage, %) assessed by transthoracic echocardiography. | VCI respiratory variation will be assessed using transthoracic echocardiography and expressed as the collapsibility index. Collapsibility index will be measured as the ratio between IVC diameter in inspiration (outcome 17) and IVC diameter in expiration (outcome 18) expressed in %. | 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). | Evaluation of lung comet presence measured by an 8-points lung echography and rated on a scale ranging from 0 (minimum - best outcome : no congestion) to 10 (maximum - worst outcome : maximum congestion) per point. | 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. |
| Heart rate in Beats Per Minute (BPM). | Multiple daily measurements : 4 times a day, 5 days a week for 3 weeks. |
| Heart rate variability in millisecond (ms). | Multiple daily measurements : 4 times a day, 5 days a week for 3 weeks. |
| Blood pressure in mmHg. | Blood pressure will be measured daily for 3 weeks and at 3-month follow-up. | Up to 3 weeks and at 3-month follow-up. |
| Monitoring of changes in pulmonary blood pressure. | Changes in pulmonary blood pressure will be measured with echocardiography. | Day 1 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. | Evaluation of the patient's body composition parameters. This measure includes the assessment of fluid distribution-Total Body Water (TBW), Intracellular Water (ICW), and Extracellular Water (ECW)-as well as tissue compartments: body protein mass, body mineral mass, and fat mass. The device records multiple parameters, the analysis will focus specifically on these pre-specified indicators of body composition. | 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. | Weight will be measured before and after each sauna session. | Up to 3 weeks. |
| Specific to the sauna group : blood pressure in mmHg. | Blood pressure will be measured before and after each sauna session. | Up to 3 weeks. |
| Specific to the sauna group : temperature in °C. | Temperature will be measured before and after each sauna session. | Up to 3 weeks. |
| Specific to the sauna group : heart rate in Beats Per Minute (BPM). | Heart rate will be measured continuously during each sauna session. | Up to 3 weeks. |
| Specific to the sauna group : sodium chloride concentration in sweat. | The concentration of sodium chloride in sweat will be measured during one sauna session per week (three measurements in total). | Up to 3 weeks. |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D029002 | Steam Bath |
| ID | Term |
|---|---|
| D001452 | Balneology |
| D013812 | Therapeutics |
| D006979 | Hyperthermia, Induced |
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