FRESH-UP Trial: Fluid Restriction May Be Unnecessary in Stable Heart Failure Patients

 In a practice-changing revelation presented at ACC.25 in Chicago and published in Nature Medicine, the FRESH-UP trial has challenged a long-standing recommendation: limiting fluid intake in heart failure (HF) patients.

The trial found no benefit from fluid restriction in patients with mild to moderate heart failure symptoms, raising the question—is it time to retire the water bottle warnings?

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Study Snapshot

• Name: FRESH-UP

• Design: Randomized, multicenter, controlled trial

• Participants: 504 patients from 7 medical centers in the Netherlands

  • Mean age: 69.2 years

  • 67.3% male

  • 87.1% with NYHA Class II symptoms

  • 51% on loop diuretics

• Groups:

  • Fluid restriction: Max 1,500 mL/day (n=250)

  • Liberal intake: Drink as desired (n=254)

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Inclusion Criteria

• Diagnosed with heart failure (mild to moderate symptoms)

• NYHA Class II or III

• Stable on standard HF therapy, including beta-blockers, ACE inhibitors/ARBs/ARNI, and/or loop diuretics

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Exclusion Criteria

• Advanced kidney disease or severe electrolyte imbalances

• Recent HF hospitalization (within the past 30 days)

• Life expectancy <6 months due to non-cardiac illness

• Cognitive impairments affecting adherence

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Key Measures

• Primary Endpoint:

  • Change in KCCQ-OSS (Kansas City Cardiomyopathy Questionnaire – Overall Summary Score) at 3 months

• Secondary Endpoints:

  • All-cause mortality

  • Heart failure hospitalizations

  • Intravenous diuretic use

  • Acute kidney injury (AKI)

  • Thirst distress

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What Did the Trial Find?

At 3 months, the KCCQ-OSS scores showed no significant difference:

• Liberal intake group: Score = 74.0

• Fluid restriction group: Score = 72.2

And at 6 months, there were no differences in:

• Mortality

• HF hospitalizations

• Use of IV diuretics

• Acute kidney injury

However, thirst-related distress was significantly worse in the fluid restriction group.

Actual fluid consumption:

• Liberal intake group: ~1,764 mL/day

• Restricted group: ~1,480 mL/day

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Clinical Meaning?

According to the researchers:

“We found no signal that fluid restriction offers benefit—or that liberal intake causes harm. Patients with stable HF can safely drink to thirst.”

This aligns with growing views that over-restricting fluids may add burden without benefit, especially in outpatient HF care.

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Take-Home Points

• Fluid restriction (1,500 mL/day) in stable heart failure patients did not improve quality of life or clinical outcomes.

• Liberal fluid intake was not harmful—no increase in mortality, hospitalization, or kidney injury.

• Patients allowed to drink freely had less thirst distress.

• Study supports individualized, patient-centered hydration plans rather than blanket fluid restrictions.

• These findings are ready for immediate implementation in stable outpatient HF care.