Low sodium diet for Heart Failure

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Toronto General Hospital, Toronto, Canada
Heart Failure
Low sodium diet - Other
Eligibility
18+
All Sexes
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Study Summary

This study is evaluating whether a low sodium diet can improve outcomes for people with chronic heart failure.

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Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

This trial is evaluating whether Low sodium diet will improve 1 primary outcome and 3 secondary outcomes in patients with Heart Failure. Measurement will happen over the course of 12 months.

12 months
Composite Clinical Outcomes
Exercise capacity
NYHA functional class
Quality of life (KCCQ)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Usual Care
1 of 2
Low sodium diet
1 of 2
Active Control
Experimental Treatment

This trial requires 806 total participants across 2 different treatment groups

This trial involves 2 different treatments. Low Sodium Diet is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Low sodium diet
Other
Low sodium diet (65 mmol or 1500 mg/day)
Usual CareGeneral advice to limit dietary sodium as it is provided during routine clinic practice

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 months for reporting.

Closest Location

Toronto General Hospital - Toronto, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients recruited if they are 18+ years or older, with confirmed diagnosis of HF (both reduced and preserved systolic function are eligible), NYHA class II-III, and willing to sign informed consent.

Patient Q&A Section

What does low sodium diet usually treat?

"The low sodium diet as the first option to overcome heart failure with diuretics and aldosterone blockers should be reconsidered and should be introduced as the first step to recover the left ventricle function." - Anonymous Online Contributor

Unverified Answer

What causes heart failure?

"Genetic conditions including cystic fibrosis, Brugada syndrome, Long QT syndrome, and Barth syndrome are also risk factors for developing heart failure. Diabetes mellitus and high blood pressure are known triggers of heart failure. There are no clear signs or symptoms that lead to the diagnosis of advanced heart failure." - Anonymous Online Contributor

Unverified Answer

What are common treatments for heart failure?

"In a general outpatient medical setting, treatment for a person with CHF is extensive because of chronic problems with the heart, uncontrolled by the individual. However, for ambulatory care patients admitted to hospital with CHF, the scope of therapy is extremely limited, and often even reduced." - Anonymous Online Contributor

Unverified Answer

What is heart failure?

"Heart failure is a serious condition that affects more than 2.5 million Americans each year. It begins with the heart muscle becoming weakened from many years of high demands, usually from high blood pressure or coronary artery disease. The heart muscle can stiffen, and, if left untreated, can eventually lose the ability to pump blood effectively to the body. Signs and symptoms include shortness of breath, fatigue, chest pain and palpitations. Other factors can also contribute to a worsening heart failure, such as high blood pressure, obesity and diabetes." - Anonymous Online Contributor

Unverified Answer

Can heart failure be cured?

"There is evidence that a large percentage of patients who were in NYHA functional classes II-III at the start of treatment, have a functional classification better than NYHA classes II and III after 5 yr of treatment. Data from a recent study, as well as the long-term (15 yr plus) survival and low-rate of progression (2% 2 yr) in this group, imply that patients may recover from heart failure with appropriate treatment. Further studies are required to ascertain whether patients with moderate CHF can return to pre-CHF functional status following successful management." - Anonymous Online Contributor

Unverified Answer

What are the signs of heart failure?

"Heart failure signs and symptoms may vary with the severity of the disease and how fast its progression has progressed. It is important that people with heart failure be aware that symptom presentation changes throughout the course of an HF episode. Each person with heart failure has different ways of communicating distress and it is also possible that some symptoms may be more important to them than others. The importance of self-monitoring cannot be over-emphasised. The most common signs include: leg or thigh swelling, tiredness, shortness of breath, lightheadedness, vomiting, dizziness, and ankle swelling. It may also include fainting or feeling light-headed/weak, irregular heartbeat, feeling breathless at rest, and cough." - Anonymous Online Contributor

Unverified Answer

How many people get heart failure a year in the United States?

"This article reports that heart failure affects approximately 16.5 million adults in the U.S. each year. Moreover, heart failure represents the top 10% of all hospitalizations among patients with heart disease, accounting for $9.6 billion in costs annually." - Anonymous Online Contributor

Unverified Answer

How does low sodium diet work?

"The low Na diet had a significant impact on reducing the blood pressure and increasing the stroke volume in both the HFpEF patients and the subjects with normal weight. And it can be an effective therapy for improving the condition of HFpEF patients." - Anonymous Online Contributor

Unverified Answer

Is low sodium diet typically used in combination with any other treatments?

"The combination of a low-sodium diet with either ACE inhibitors or ACEI/ARB for heart failure provides similar absolute reduction in heart failure-related hospitalization regardless of the type of salt restriction (reduced sodium or low chloride salt substitutes) in use." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating heart failure?

"While medical advances are making the diagnosis [and treatments] of heart failure is advancing, it still remains a deadly disease with no effective medical treatment. In the future, research will have to overcome the current limitations of the treatment of heart failure by enhancing cardiac function, with an aim at reducing mortality and morbidity." - Anonymous Online Contributor

Unverified Answer

Is low sodium diet safe for people?

"Low sodium diet reduces the risk of heart failure in older adults with normal ejection fraction. There does not appear to be a greater risk of other adverse effects, such as increased risk of death, myocardial infarction, or stroke, although the sample size is small and may be underpowered. Further studies are required to support these findings." - Anonymous Online Contributor

Unverified Answer

What is the latest research for heart failure?

"With advances in treatment of heart failure, research will only broaden. This may be the case with regard to new medications in the future; other ways of relieving symptoms are also being researched e.g. new pacing devices (e.g. implantable defibrillators, implanted cardioverter-defibrillator [ICD]; implanting small wires into the heart), and devices (e.g. CRT) that help monitor heart function and alert the user to irregularities/fatal arrhythmias. Further research will clarify the question (for researchers and clinicians) of whether cardiac resynchronization therapy [CRT, ICD] should be considered as the gold-standard, treatment for chronic [i.e." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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