Heart Failure
Conditions
Keywords
congestion, sauna, heart failure
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.
Interventions
DEVICESauna
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.
Sponsors
BAUDRY Guillaume
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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…
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median change in NT-proBNP levels. | Between randomization and the end of the third week. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoconcentration biomarkers : total protein. | Time Frame: Day 1, end of weeks 1, 2, and 3, and 3-month follow-up. | Hemoconcentration was assessed using total protein (g/L). |
| 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. | 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 ". |
| Congestion score: Ambrosy congestion score. | Day 1, end of week 3, and 3-month follow-up. | 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). |
| 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. | The minimum value is "0" (best outcome) and means "no dyspnea". The maximum value is "10" (worst outcome) and means "maximum dyspnea". |
| 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. | End of weeks 1, 2, and 3 and 3-month follow-up. | 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. |
| 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. | Day 1, end of weeks 1, 2, and 3, and 3-month follow-up. | 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. |
| 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. | 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). |
| Hemoconcentration biomarkers : Hct. | Day 1, end of weeks 1, 2, and 3, and 3-month follow-up. | Hemoconcentration was assessed using hematocrit (%). |
| Hemoconcentration biomarkers : copeptin. | Time Frame: Day 1, end of weeks 1, 2, and 3, and 3-month follow-up. | Hemoconcentration was assessed using copeptin concentrations (pmol/L). |
| 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. | The inferior vena cava (IVC) diameter will be measured in millimeters using transthoracic echocardiography. |
| 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. | IVC diameter will be measured in millimeters using transthoracic echocardiography. |
| 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. | 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 %. |
| Lung ultrasound score (8 points). | Day 1, end of week 3, and 3-month follow-up. | 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. |
| 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. | Up to 3 weeks and at 3-month follow-up. | Blood pressure will be measured daily for 3 weeks and at 3-month follow-up. |
| Monitoring of changes in pulmonary blood pressure. | Day 1 and at 3-month follow-up. | Changes in pulmonary blood pressure will be measured with echocardiography. |
| 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. | 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. |
| Specific to the sauna group : weight in kilograms. | Up to 3 weeks. | Weight will be measured before and after each sauna session. |
| Specific to the sauna group : blood pressure in mmHg. | Up to 3 weeks. | Blood pressure will be measured before and after each sauna session. |
| Specific to the sauna group : temperature in °C. | Up to 3 weeks. | Temperature will be measured before and after each sauna session. |
| Specific to the sauna group : heart rate in Beats Per Minute (BPM). | Up to 3 weeks. | Heart rate will be measured continuously during each sauna session. |
| Hemoconcentration biomarkers : Hb. | Day 1, end of weeks 1, 2, and 3, and 3-month follow-up. | Hemoconcentration was assessed using hemoglobin (g/dL). |
| Specific to the sauna group : sodium chloride concentration in sweat. | Up to 3 weeks. | The concentration of sodium chloride in sweat will be measured during one sauna session per week (three measurements in total). |
Countries
France
Contacts
CONTACTGuillaume Baudry
Outcome results
None listed