Unlimited or Restricted Fluid Intake in Patients With Heart Failure

Sponsor

Region Stockholm (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05931614

Collaborator

(none)

250

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Other: Unlimited fluid restrictions	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Unlimited or Restricted Fluid Intake in Patients With Heart Failure: a Randomized Controlled Intervention Study

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Unlimited fluid intake Patients have no restrictions of fluid intake	Other: Unlimited fluid restrictions Patients are recommended unlimited fluid intake
No Intervention: Restricted fluid intake Patients have restrictions in fluid intake of 1500 ml/day

Arm

Intervention/Treatment

Experimental: Unlimited fluid intake

Patients have no restrictions of fluid intake

Other: Unlimited fluid restrictions

Patients are recommended unlimited fluid intake

No Intervention: Restricted fluid intake

Patients have restrictions in fluid intake of 1500 ml/day

Outcome Measures

Primary Outcome Measures

B-lines [12 weeks]
The patients will be investigated with lung ultrasound to screen for b-lines (comet tail artifacts) to assess pulmonary congestion
NT-proBNP [12 weeks]
Specific biomarkers for heart failure (blood test)

Secondary Outcome Measures

Heart failure symptoms [12 weeks]
Symptoms of heart failure measured by questionnaires
HRQoL [12 weeks]
Health related quality of life measured with EQ5D
Physical Capacity [12 weeks]
Physical Capacity measured by six minutes walktest
Hospital readmissions [12 weeks]
Hospital readmissions within three months

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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