search
Back to results

Unlimited or Restricted Fluid Intake in Patients With Heart Failure

Primary Purpose

Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Unlimited fluid restrictions
Sponsored by
Region Stockholm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure focused on measuring Quality of life, Intervention, Thirst distress, Symptoms, Physical capacity, Hospital readmissions, Lung ultrasound, Fluid intake, B-lines, NT-ProBNP, Heart failure, Fluid restriction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosed with heart failure with reduced ejection fraction (EF <50%) within 3 months hospitalized due to HF deterioration at Karolinska University Hospital at the in-hospital cardiology wards. Ability to provide informed consent. Exclusion Criteria: Reversible cause of HF (thyroid disorders, severe anemia, etc.) Hyponatremia at baseline (sodium < 130 mmol/L) Kidney function measured with eGFR where eGFR of < 30mL/min/1.73m2 at baseline Scheduled cardiac surgery within 3 months Recent (within 3 months) coronary intervention (percutaneous coronary intervention or coronary artery bypass graft surgery) Comorbidity for which fluid restriction is advised Life expectancy < 6 months Ongoing investigation for eligebility of heart transplantation and/or LVAD Pregnancy or planned pregnancy Particiaption in another ongoing clinical trial

Sites / Locations

  • Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Unlimited fluid intake

Restricted fluid intake

Arm Description

Patients have no restrictions of fluid intake

Patients have restrictions in fluid intake of 1500 ml/day

Outcomes

Primary Outcome Measures

B-lines
The patients will be investigated with lung ultrasound to screen for b-lines (comet tail artifacts) to assess pulmonary congestion
NT-proBNP
Specific biomarkers for heart failure (blood test)

Secondary Outcome Measures

Heart failure symptoms
Symptoms of heart failure measured by questionnaires
HRQoL
Health related quality of life measured with EQ5D
Physical Capacity
Physical Capacity measured by six minutes walktest
Hospital readmissions
Hospital readmissions within three months

Full Information

First Posted
June 16, 2023
Last Updated
June 27, 2023
Sponsor
Region Stockholm
search

1. Study Identification

Unique Protocol Identification Number
NCT05931614
Brief Title
Unlimited or Restricted Fluid Intake in Patients With Heart Failure
Official Title
Unlimited or Restricted Fluid Intake in Patients With Heart Failure: a Randomized Controlled Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Stockholm

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if unlimited fluid intake can improve quality of life and decrease thirst distress in patients with heart failure, without an impact on symptoms, physical capacity, and hospitals readmissions.
Detailed Description
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 the improvement in medical treatment, we still face challenges in readmission to hospital and in 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 quality of life, physical function, signs and symptoms and readmission to hospital.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Quality of life, Intervention, Thirst distress, Symptoms, Physical capacity, Hospital readmissions, Lung ultrasound, Fluid intake, B-lines, NT-ProBNP, Heart failure, Fluid restriction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Unlimited fluid intake
Arm Type
Experimental
Arm Description
Patients have no restrictions of fluid intake
Arm Title
Restricted fluid intake
Arm Type
No Intervention
Arm Description
Patients have restrictions in fluid intake of 1500 ml/day
Intervention Type
Other
Intervention Name(s)
Unlimited fluid restrictions
Intervention Description
Patients are recommended unlimited fluid intake
Primary Outcome Measure Information:
Title
B-lines
Description
The patients will be investigated with lung ultrasound to screen for b-lines (comet tail artifacts) to assess pulmonary congestion
Time Frame
12 weeks
Title
NT-proBNP
Description
Specific biomarkers for heart failure (blood test)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Heart failure symptoms
Description
Symptoms of heart failure measured by questionnaires
Time Frame
12 weeks
Title
HRQoL
Description
Health related quality of life measured with EQ5D
Time Frame
12 weeks
Title
Physical Capacity
Description
Physical Capacity measured by six minutes walktest
Time Frame
12 weeks
Title
Hospital readmissions
Description
Hospital readmissions within three months
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with heart failure with reduced ejection fraction (EF <50%) within 3 months hospitalized due to HF deterioration at Karolinska University Hospital at the in-hospital cardiology wards. Ability to provide informed consent. Exclusion Criteria: Reversible cause of HF (thyroid disorders, severe anemia, etc.) Hyponatremia at baseline (sodium < 130 mmol/L) Kidney function measured with eGFR where eGFR of < 30mL/min/1.73m2 at baseline Scheduled cardiac surgery within 3 months Recent (within 3 months) coronary intervention (percutaneous coronary intervention or coronary artery bypass graft surgery) Comorbidity for which fluid restriction is advised Life expectancy < 6 months Ongoing investigation for eligebility of heart transplantation and/or LVAD Pregnancy or planned pregnancy Particiaption in another ongoing clinical trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carolin Nymark, PhD
Phone
+46725955887
Email
carolin.nymark@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolin Nymark, PhD
Organizational Affiliation
Karolinska Universitetssjukhuset, Heart and Vascular Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolin Nymark, PhD
Phone
+46725955887
Email
carolin.nymark@regionstockholm.se

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Unlimited or Restricted Fluid Intake in Patients With Heart Failure

We'll reach out to this number within 24 hrs