Unlimited or Restricted Fluid Intake in Patients With Heart Failure

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05931614
• Other study ID #: K 2023-3124
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2024
• Est. completion date: September 2030

Study information

• Verified date: April 2024
• Source: Region Stockholm
• Contact: Carolin Nymark, PhD
• Phone: +46725955887
• Email: carolin.nymark[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: September 2030
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Unlimited fluid restrictions
Patients are recommended unlimited fluid intake

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Region Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	B-lines	The patients will be investigated with lung ultrasound to screen for b-lines (comet tail artifacts) to assess pulmonary congestion	12 weeks
Primary	NT-proBNP	Specific biomarkers for heart failure (blood test)	12 weeks
Secondary	Heart failure symptoms	Symptoms of heart failure measured by questionnaires	12 weeks
Secondary	HRQoL	Health related quality of life measured with EQ5D	12 weeks
Secondary	Physical Capacity	Physical Capacity measured by six minutes walktest	12 weeks
Secondary	Hospital readmissions	Hospital readmissions within three months	12 weeks