Results
Ninety-seven patients (60 males and 37 females) with a mean age of 75 (±8) years agreed to participate in the study. Baseline information is shown in Table 1. Forty-nine patients were randomized to the intervention group and 48 patients to the control group. Two patients withdrew consent after randomization (one in each group), three dropped out due to other disabling diseases (two in the intervention and one in the control group), and two patients died (one in each group). Thus, 45 patients in each group completed the study. In 67 cases it was the same physician examining the patients at baseline and follow-up and in the rest it was two different physicians who had worked together for 5–25 years. One physician made 72% of the evaluations.
Improvement in the primary composite endpoint was seen in 51% of the patients in the intervention group and in 16% in the control group, P < 0.001 (Figure 1), mostly due to an improved NYHA class and reduced oedema (Table 2). Changes in the specific components of the composite endpoint are shown in Figure 2.
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Figure 1.
Numbers of improved or deteriorated patients in the intervention and control groups. P < 0.001 is for the number for patients with the improved vs. the deteriorated composite endpoint.
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Figure 2.
Change in the different components of the composite endpoint. Qol, quality of life.
Twelve patients in the intervention group and nine patients in the control group were excluded from the urine analysis, owing to PABA <50% in all of the urine samples. There were significant reductions in urine volumes and urine sodium in the intervention group from baseline to follow-up compared with the control group (Table 2). Neither weight, thirst, nor QoL were affected by the salt and fluid restrictions. Dose of diuretics was reduced in five patients in the intervention group and three in the control group. Spironolactone was decreased in two patients in the intervention group and in one in the control group, and the dose was increased in one patient in the control group. In the intervention group, the dose of ACE inhibitor/ARB was increased by the general practitioner (GP) in one patient for unclear reasons 4 weeks after study start, and after 6 weeks in the study another patient was told to halve his dose of ARB due to a long period of fever. No dose changes were seen in the control group.One patient in the intervention group and two in the control group were hospitalized.
A total of 38 patients (21 patients in the intervention group and 17 controls) were contacted by telephone 10–12 months after their last visit. Three in the intervention group and four in the control group were either too tired or not interested in taking part in the interview. All participants in the intervention group considered that they had modified their diet during the study period, and 11 of 21 said that they maintained this dietary pattern. Four patients no longer prepared their own meals. In the control group, 4 of 13 felt that they had made major dietary changes after the end of the 12-week study period.