Diastolic DysfunctionNCT01896908
Effect of Dietary Sodium Restriction in the Management of Patients With Heart Failure and Diastolic Dysfunction
A study testing Sodium restriction in people with Diastolic Dysfunction, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diastolic Dysfunction
- What is being tested?
- Sodium restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2013to 31 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035003
About this study
Official title: Effect of Dietary Sodium Restriction in the Management of Patients With Heart Failure and Preserved Ejection Fraction: a Randomized Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Diastolic Dysfunction
- Being tested
- Sodium restriction
- Keywords
- diastolic dysfunction, Sodium restriction, Randomized clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Sodium restriction (1.6g sodium daily - 4g salt) combined with 800 ml of fluid intake Receives: Other: Sodium restriction |
| Control | No intervention | Normal sodium diet (4g sodium daily - 10g salt) and free fluid intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: seven days or hospital discharge
Secondary outcomes (4)
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)
Measured: Seven days or hospital discharge
Neurohormonal activation
Assessment of neurohormonal activation shall include measurement of serum renin, aldosterone, and BNP levels.
Measured: 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.
Measured: Seven days or hospital discharge
Readmission rate at 30 days
Measured: Patients shall be followed for 30 days after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startMar 2013
- Primary completion31 Jul 2016
- Study completion31 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diastolic DysfunctionStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eneida Rabelo da Silva, ScD, Principal investigator, HCPA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896908
- Sponsor's protocol ID
- HCPA - 120437
- Status last verified
- Aug 2017
- First submitted
- 8 Jul 2013
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29793053d'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.
PubMed 25187436
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Sodium Restriction in the Management of Patients With Heart Failure and Preserved Ejection Fraction: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01896908
- Acronym / sponsor ID
- HCPA - 120437
- Conditions
- Diastolic Dysfunction
- Keywords
- diastolic dysfunction, Sodium restriction, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- 31 Jul 2016 (actual)
- Study completion
- 31 Jul 2016 (actual)
- First posted
- 11 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Sodium restrictionSodium 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium restrictionPatients 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. | Other | Intervention |
Primary outcome
Weight loss
Time frame: seven days or hospital discharge
4 secondary outcomes
Assessment of clinical stability
Time frame: Seven days or hospital discharge
Neurohormonal activation
Time frame: On admission and at discharge
Daily perception of thirst
Time frame: Seven days or hospital discharge
Readmission rate at 30 days
Time frame: Patients shall be followed for 30 days after discharge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Derived from this study: PubMed 29793053Machado 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.
- Derived from this study: PubMed 25187436d'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.
- Individual participant dataSharing planned: Undecided
Related trials for Diastolic Dysfunction
Not yet recruiting
Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
Valvular Heart Disease Patients, Aortic Stenosis
Recruiting
Optimised Cardiovascular and Renal Protection in Patients With Chronic Kidney Disease and Cardiovascular Disease
Chronic Kidney Disease, Heart Failure With Preserved Ejection Fraction (HFPEF)
Not yet recruitingObservational study
Changes in Intramyocardial Fat Assessed by Cardiac CT Before and After Bariatric Surgery and Their Relationship With Cardiac Diastolic Function
Obesity, Diastolic Dysfunction
Active, not recruitingObservational study
Mechanisms of Cardiac Dysfunction in HIV and the Effect of Statins: A Cardiac MRI Study
HIV Infections
Not yet recruiting
Sacubitril/Valsartan Versus Valsartan Alone on Left Atrial Volume Index in Hypertensive Patients
Hypertension, Left Ventricular Diastolic Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eneida Rabelo da Silva, ScD principal investigator
HCPA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium restriction in people with Diastolic Dysfunction, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: seven days or hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01896908, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2017.