NCT01896908

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 11, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2016

Completed
Last Updated

August 2, 2017

Status Verified

August 1, 2017

Enrollment Period

3.4 years

First QC Date

July 8, 2013

Last Update Submit

August 1, 2017

Conditions

Diastolic Dysfunction

Keywords

diastolic dysfunctionSodium restrictionRandomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    seven days or hospital discharge

Secondary Outcomes (4)

  • Assessment of clinical stability

    Seven days or hospital discharge

  • Neurohormonal activation

    On admission and at discharge

  • Daily perception of thirst

    Seven days or hospital discharge

  • Readmission rate at 30 days

    Patients shall be followed for 30 days after discharge.

Study Arms (2)

Intervention

EXPERIMENTAL

Sodium restriction (1.6g sodium daily - 4g salt) combined with 800 ml of fluid intake

Other: Sodium restriction

Control

NO INTERVENTION

Normal sodium diet (4g sodium daily - 10g salt) and free fluid intake

Interventions

Sodium restrictionOTHER

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of both sexes
  • Age equal to or above 18 years
  • Diagnosis of heart failure whit preserved ejection fraction (LVEF\> 50%)
  • Patients hospitalized for heart failure decompensation whit hospital admission within 36 hours, who agree to participate in the study by signing the informed consent.

You may not qualify if:

  • Patients who present values of endogenous creatinine clearance less than or equal to 30 ml / min;
  • Cardiogenic shock,
  • Those with survival compromised by another disease in evolution and / or difficulty adhering to treatment (dementia, cognitive impairment)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035003, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 29793053DERIVED

  • 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.

    PMID: 25187436DERIVED

Study Officials

  • Eneida Rabelo da Silva, ScD

    HCPA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2013

First Posted

July 11, 2013

Study Start

March 1, 2013

Primary Completion

July 31, 2016

Study Completion

July 31, 2016

Last Updated

August 2, 2017

Record last verified: 2017-08

Locations

BR(1)