The largest randomized study of fluid intake restrictions showed no benefit from the restrictions, according to its senior author.
Cardiologists and other clinicians have long advised patients with heart failure to limit their fluid intake, on the theory that doing so would reduce fluid buildup in the lungs and extremities. Results from what was billed as the first large randomized controlled trial of fluid intake presented at the American College of Cardiology (ACC) Scientific Session today may call into question the wisdom of that advice.
Roland van Kimmenade, M.D.
“There was not a signal there was any benefit from the fluid restriction,” Roland van Kimmenade, M.D., a cardiologist at Radboud University Medical Center in Nijmegen, Netherlands, and the study’s senior author, said at a press conference held yesterday prior to the embargoed release of the results this morning at the meeting. They were published simultaneously in Nature Medicine
After three months, the study, dubbed FRESH-UP, showed a slightly higher health status among the 254 participants whom Van Kimmenade and his colleagues randomly assigned to the group who were told they could drink as much fluid as they would like compared with the 250 participants who were given the standard advice to drink no more than 1,500 milliliters per day, which is the equivalent of just over six cups. Health status was measured by the results of the Kansas City Cardiomyopathy Questionnaire (KCCQ), which is commonly used in cardiology studies. There was a 2.17-point difference favoring the liberal intake group, but it fell short of the primary end point set by van Kimmenade and his colleagues prior to the study. There was, though, a marked difference in “thirst distress” as measured by the Thirst Distress Scale in Heart Failure scale (16.9 in the liberal fluid intake group vs 18.6 in the restricted group).
Little if any difference on an array of secondary outcomes designed to assess whether the liberal intake caused any harm led van Kimmenade to advise abandoning fluid restriction limits, which guideline writers have acknowledged are not based on strong evidence.
“Our conclusion is that in patients with stable heart failure there is no need for fluid restriction,” said van Kimmenade was quoted as saying in a news release prepared by ACC. “This is an important message to heart failure patients all over the world and can be implemented immediately.”
The difference in daily fluid intake between the liberal and restricted was large: 284 milliliters, which is the equivalent of 1.2 cups. About half (48.8% in the liberal intake group and 44.4% in the restricted one) of the patients had not been told to limit their fluid intake prior to the study, which may help explain why the study results did not meet the primary end point (many of the people randomly assigned to liberal intake were already drinking as much as they wanted). Van Kimmenade also noted that the participants had a fairly high health status at the beginning of the study, so there was little room for improvement — and perhaps another factor contributing to the shortfall on the primary end point.
The inclusion criteria for FRESH-UP included a diagnosis of heart failure, using European Society of Cardiology guidelines, at least six months prior to enrollment and mild to moderate heart failure symptoms (New York Heart Association Class II and III, with more than 85% in Class II). Among the exclusion criteria were recent (within the past 14 days) changes in heart failure medical therapy and a heart failure-related hospital admission in the past three months. Approximately half of the participants had heart failure with reduced ejection fraction, and half had preserved ejection. Most participants were taking standard heart failure medications and approximately half (52.4% in the liberal intake group and 50% in the restricted) were taking loop diuretics
Van Kimmenade described the study as “patient-driven” and said it had benefited from crowdfunding. The news release identified the Dutch Heart Foundation and university grants as the funding sources. He said the fluid restriction advice bothers heart failure patients.
“People with heart failure have this list, and they have to constantly write down how much they drink in order to see if they have reached 1.5 liters and make the decision, should I have a cup of coffee in the morning with my spouse or should I have a cup of tea with my friend in the afternoon?” he said.
Shelley Hall, M.D.
One of the discussants at the press conference, Shelley Hall, M.D., chief of transplant cardiology at Baylor Dallas, part of Baylor Scott and White, complimented van Kimmenade for tackling an issue that may not be glamorous but affects patients’ quality of life. Hall said the effect of unquenched thirst on people’s lives should not be underestimated. She noted cardiology’s success in dealing with mortality and identifying new medications but called for more studies such as FRESH-UP that focus on quality of life.
“We need to focus on their [patients’] quality of life,” she said. “Heart failure patients have miserable qualities of life, so starting to find interventions that improve that quality of life, whether it be behavior modification, medication or devices, is really where we should be focusing in the heart failure space now.”
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