Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Capio Sankt Görans Hospital | OTHER |
| Ersta Hospital, Sweden | OTHER |
Not provided
Not provided
Not provided
Not provided
Heart failure is the most common cause of admission to hospital and is associated with high morbidity and mortality. Treatment options consist of medical- and device treatment and self-care strategies, where fluid restriction has been one of the components in the self-care management of patients with chronic heart failure. The medical treatment has progressed and improved over the years and considerably over the last few years, which has decreased symptoms and improved physical function of these patients. Despite our great success in the medical treatment of heart failure, we still face challenges in hospital readmissions and treatment strategies. It contributes to the increased need of evidence on, if and how, fluid intake and fluid restriction should be used as a self-care method. Fluid restriction as a self-care treatment is still commonly recommended in heart failure management although the scientific clinical evidence is lacking. Fluid restriction is associated with a higher degree of thirst and lower rated quality of life, and there is no consensus on how fluid restriction should be used, no plan for individualized treatment and no agreement on how fluid restriction should be a part of the patient self-care treatment. There is therefore a need for knowledge on how heart failure patients are affected by fluid restriction regarding clincal signs and symptoms of heart failure, quality of life, physical function, readmission to hospital or heart failure events. The primary aim of the study is to investigate whether a free fluid intake is safe compared to a restricted fluid intake, regarding clinical signs of heart failure measured as the presence of B-lines and/or an increase in NT-proBNP. The secondary aim is to clarify whether an unlimited fluid intake can improve quality of life and reduce thirst without affecting heart failure symptoms, physical activity, hospital readmissions and/or heart failure events.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Free fluid intake | Experimental | Patients have no restrictions of fluid intake |
|
| Restricted fluid intake | No Intervention | Patients are recommended a restricted fluid intake of 1500 mL/day |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Free fluid intake | Behavioral | Patients are recommended a free fluid intake |
|
| Measure | Description | Time Frame |
|---|---|---|
| B-lines | The patients will be investigated with lung ultrasound to screen for B-lines (comet tail artifacts) to assess pulmonary congestion | 12 weeks |
| NT-proBNP | Specific biomarkers for heart failure (blood test) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Heart failure symptoms | Symptoms of heart failure measured by questionnaires | 12 weeks |
| HRQoL | Health related quality of life measured with EQ5D |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carolin Nymark, PhD | Contact | +46725955887 | carolin.nymark@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Carolin Nymark, PhD | Karolinska Universitetssjukhuset, Heart and Vascular Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Recruiting | Stockholm | 17176 | Sweden |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 weeks |
| Thirst distress | 12 weeks |
| Self-Care | Self-care in chronic illness, measured by a questionnaire | 12 weeks |
| IVC | Ultrasound of Inferior Vena Cava (IVC) diameter and respiratory variation. | 12 weeks |
| Pleural effusion | Lungultrasound with screening for pleural effusion | 12 weeks |
| Physical Capacity | Physical Capacity measured by six minutes walktest | 12 weeks |
| Hospital readmissions | Hospital readmissions within three months | 12 weeks |
| Heart failure events | Contact with helathcare due to heart failure symtoms, increased use of diuretics with/without admission etc. | 12 weeks |