To investigate the effect of fluid restriction versus liberal fluid intake on QoL in chronic HF.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters are QoL at 3 months after randomization, as assessed
with the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score.
Secondary outcome
Secondary and other study parameters are thirst distress using a validated
thirst distress scale, QoL as assessed with the KCCQ Clinical Summary Score and
each of the separate domains, QoL as assessed with a visual analogue scale
(EQ-5D-5L), serum biomarkers (NT-proBNP, sodium, osmolality); and the
occurrence of adverse events such as death, hospitalisations and need for
iv-loop diuretics during the 6-month follow-up.
Background summary
Chronic heart failure (HF) is an increasing global health concern with over 20
million patients worldwide. Although it is common practice for clinicians to
advice fluid restriction to prevent symptoms and hospitalisations due to fluid
retention, there is no evidence to support this treatment strategy, as also
stated in the most recent HF guidelines. Moreover, fluid restriction is
associated with thirst distress and may adversely impact quality of life (QoL).
Study objective
To investigate the effect of fluid restriction versus liberal fluid intake on
QoL in chronic HF.
Study design
Multi-centre open-label 1:1 randomized clinical trial with 6 months follow-up.
Intervention
On a background of standard guideline-directed medical therapy patients will be
randomized to an advice by the treating physician and/or HF specialized nurse
of either fluid restriction of 1500cc/24hours versus liberal fluid intake for a
period of 3 months.
Study burden and risks
Participants will be recruited and followed at the specialized HF outpatient
clinic according to standard clinical practice with a 3-month interval
including standard laboratory analyses (renal function, electrolytes,
NT-proBNP). Subjects will be randomized for 3 months to an advice of either
liberal fluid intake or fluid restriction of 1500cc/24hours, of which the
latter is current standard clinical practice. At baseline and after 3 months,
participants will be asked to fill out a QoL questionnaire. In addition,
subjects will be asked to report their daily fluid intake at week 6.
In terms of benefits and risks, fluid restriction in HF leads to an undesirable
sensation of thirst. For patients with HF, thirst can be distressing and can
decrease quality of life. There is no evidence that fluid restriction reduces
symptom burden or adverse events such as HF hospitalizations due to fluid
retention, whereas liberal fluid intake may result in increased quality of life
due a decrease in thirst. Given the vast target population of chronic HF
patients worldwide, and the simplicity of the intervention, potentially
millions of HF patients may benefit from the results of this study.
Geert Grooteplein 10
Nijmegen 6525GA
NL
Geert Grooteplein 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
• Diagnosis of chronic heart failure according to the prevailing guidelines > 6
months prior to randomization
• Adult (age >= 18 years)
Exclusion criteria
• Reversible cause of HF (thyroid disorders, severe anemia, vitamin
deficiencies)
• Hospital admission for HF within 3 months of randomization
• Hyponatremia at baseline (sodium <130mmol/l)
• Estimated Glomerular Filtration Rate (eGFR) of < 30ml/min/1.73 m2 at baseline
• Changes in HF medical therapy in last 14 days prior to randomization
• Scheduled cardiac surgery within 3 months of randomization
• Comorbidity for which fluid restriction is advised by a different treating
physician (e.g. nephrologist)
• Inability to provide informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04551729 |
| CCMO | NL75112.091.20 |