Image

Unlimited or Restricted Fluid Intake in Patients With Heart Failure

Unlimited or Restricted Fluid Intake in Patients With Heart Failure

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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.

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

Study details
    Heart Failure

NCT05931614

Region Stockholm

29 April 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.