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Although half of the patients with HF has normal ejection fraction or slightly altered (HF-PEF) and the prognosis differs little from those with reduced ejection fraction, the pathophysiology of HF-PEF is still poorly understood.
Sodium restriction is the most common measure of self-care oriented to HF patients for management of congestive episodes. The role of this orientation in the treatment of patients with preserved ejection fraction, however, is still unclear. The evaluation of the effects of sodium restriction on neurohormonal activation and episodes of decompensation in HF-PEF can promote a better understanding of the pathophysiological progression of this complex syndrome.
This is a randomized, parallel trial with blinded outcome assessment. The sample will include adult patients (aged ≥18 years) with a diagnosis of HF-PEF admitted for HF decompensation. The patients will be randomized to receive a diet with sodium and fluid intake restricted to 0.8 g/day and 800 mL/day respectively (intervention group) or an unrestricted diet, with 4 g/day sodium and unlimited fluid intake (control group), and followed for 7 days or until hospital discharge. The primary outcome shall consist of weight loss at 7 days or discharge. The secondary outcome includes assessment of clinical stability, neurohormonal activation, daily perception of thirst and readmission rate at 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Sodium restriction (1.6g sodium daily - 4g salt) combined with 800 ml of fluid intake |
|
| Control | No Intervention | Normal sodium diet (4g sodium daily - 10g salt) and free fluid intake |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium restriction | Other | Patients that are eligible and fulfill the inclusion criteria will be invited to participate while hospitalized, and then sign the informed consent form. Then, the dietitian on call will be notified in order to change the dietary map of the patients. The prescription diet for both the intervention and control group will be the same: DIET AS RESEARCH PROTOCOL. PATIENT WILL RECEIVE THE DIET UNTIL DAY __ / __ OR DISCHARGE. PLEASE DO NOT CHANGE IT. This will be combined with the medical staff and with the Nutrition and Dietetics service. The evaluation of outcomes after hospital discharge will be held in the institution of reference when will be performed clinical evaluation and blood samples collection for neurohormonal activation analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | seven days or hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of clinical stability | Symptomatic improvement without evidence of congestion (congestion score) Weight stable for two days, without changing more than 1kg, (daily weight) Without IV drug for HF for 48 hours (daily record of medication: diuretics, vasodilators) No increase in diuretic dose for 48 hours (daily records of medications) | Seven days or hospital discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eneida Rabelo da Silva, ScD | HCPA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035003 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29793053 | Derived | Machado d'Almeida KS, Rabelo-Silva ER, Souza GC, Trojahn MM, Santin Barilli SL, Aliti G, Rohde LE, Biolo A, Beck-da-Silva L. Aggressive fluid and sodium restriction in decompensated heart failure with preserved ejection fraction: Results from a randomized clinical trial. Nutrition. 2018 Oct;54:111-117. doi: 10.1016/j.nut.2018.02.007. Epub 2018 Mar 21. | |
| 25187436 |
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| Neurohormonal activation | Assessment of neurohormonal activation shall include measurement of serum renin, aldosterone, and BNP levels. | On admission and at discharge |
| Daily perception of thirst | A visual scale (with values ranging from 0 to 10) will be used daily to verify the degree of thirst. | Seven days or hospital discharge |
| Readmission rate at 30 days | Patients shall be followed for 30 days after discharge. |
| d'Almeida KS, Rabelo-Silva ER, Souza GC, Trojahn MM, Barilli SL, Mansson JV, Biolo A, Rohde LE, Clausell N, Beck-da-Silva L. Effect of fluid and dietary sodium restriction in the management of patients with heart failure and preserved ejection fraction: study protocol for a randomized controlled trial. Trials. 2014 Sep 4;15:347. doi: 10.1186/1745-6215-15-347. |