CLINICAL TRIAL

Treatment for Heart Failure

Class I
Recruiting · 18+ · All Sexes · Philadelphia, PA

This study is evaluating whether thyroid hormone replacement therapy may help improve heart failure symptoms for individuals with low thyroid hormone levels.

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About the trial for Heart Failure

Eligible Conditions
Heart Failure With Preserved Ejection Fraction (HFpEF) · Heart Failure · Low Triiodothyronine Syndrome

Treatment Groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Control Group 1
liothyronine or placebo
DRUG
Control Group 2
liothyronine or placebo
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
In the last year, the person's heart failure has gotten worse, to the point where they needed to start taking IV diuretics to help clear fluid from their lungs. show original
According to the HFpEF score, there is a probability of HFpEF greater than or equal to 90% show original
Elevated invasively-determined filling pressures previously (resting LVEDP >16 mmHg or mean pulmonary capillary wedge pressure [PCWP] >12 mmHg; or PCWP/LVEDP ≥25 mmHg with exercise)
The mitral E/e' ratio is greater than 14 (either lateral or septal). show original
Enlarged left atrium (LA volume index >34 ml/m2)
of congestive heart failure (CHF) is increasingly common, but the safety of chronic loop diuretic use in patients with CHF is not well established show original
Elevated natriuretic peptides (BNP levels >100 ng/L or NT-proBNP levels >300 ng/L)
indicates significant tricuspid regurgitation A tricuspid regurgitation velocity of more than 2.8 meters per second suggests significant tricuspid regurgitation. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: continuous during intervention (14 days)
Screening: ~3 weeks
Treatment: Varies
Reporting: continuous during intervention (14 days)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: continuous during intervention (14 days).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 2 primary outcomes and 4 secondary outcomes in patients with Heart Failure. Measurement will happen over the course of 8 weeks.

Peak Maximal Rate of Oxygen Consumption During Exercise (VO2 Max)
8 WEEKS
Change peak rate of oxygen consumption
8 WEEKS
Actigraphy
8 WEEKS
Change in remotely sensed difference in counts per minute (CPM)
8 WEEKS
NT-proBNP Levels
8 WEEKS
Change in B-type natriuretic peptide, Pg/mL
8 WEEKS
Measure of Quality of Life
8 WEEKS
Change Kansas City Cardiomyopathy Questionnaire, KCCQ
8 WEEKS
T3 Level
8 WEEKS
Percentage of participant T3 levels above upper limit of reference range
8 WEEKS
Cardiac Rhythm Monitoring by 14 day Patch Rhythm Assessment
CONTINUOUS DURING INTERVENTION (14 DAYS)
Percent increase (atrial fibrillation, ventricular tachycardia, supraventricular and ventricular) ectopy
CONTINUOUS DURING INTERVENTION (14 DAYS)

Who is running the study

Principal Investigator
A. C.
Prof. Anne Cappola, MD
University of Pennsylvania

Patient Q & A Section

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

Can heart failure be cured?

Heart failure is an illness that cannot be completely cured. Treatment of patients and caregivers with heart failure provides some benefit in terms of improved survival over time. However, no benefit can be achieved until heart failure symptoms are eliminated and the underlying cause of the disease is treated. Current efforts toward treating heart failure cannot currently be seen as a cure.

Anonymous Patient Answer

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

In the United States there will be more than 1.4 million new cases of HF by 2030, leading to more than 40,000 HF related deaths.

Anonymous Patient Answer

What is heart failure?

There is ambiguity and confusion about definition, epidemiology, epidemiology, prevalence, symptomatology, pathophysiology, diagnostic testing and evaluation of HF. This confusion is further compounded by the prevalence of multiple subtypes of HF. This article tries to resolve some misconceptions and to highlight the limitations of using definitions defined by clinical observations rather than biomedical principles in defining HF. One definition is that HF is a syndrome involving signs and symptoms of a heart that is failing.

Anonymous Patient Answer

What are common treatments for heart failure?

The primary treatment of heart failure is the optimization of heart failure symptoms and blood pressure, which can be aided by medications. Most individuals with severe disease will benefit from medications to control high blood pressure and to control heart valve issues. Newer medications are available, but current evidence suggests that they may not be as effective. The prognosis is not optimistic for a substantial number of individuals with heart failure. Many will develop the symptom of heart failure over a period of many years. The benefits of a device to pace the heart (cardiac resynchronization therapy) and medications for heart failure continue to be debated. Further evidence-based research is needed to determine if these therapies are effective and to identify those who will be most likely to benefit.

Anonymous Patient Answer

What are the signs of heart failure?

There are usually no signs of heart failure until left ventricular ejection fraction drops below 35 % and/or congestive heart failure develops. The signs of heart failure often are a manifestation of the underlying heart disease. Because of this overlap, no single sign or panel should be used for diagnosis of heart failure or as a screening criterion for symptomatic detection of heart failure. A cardiac catheterization should ideally be performed to rule out heart disease and assess for the severity of heart failure.

Anonymous Patient Answer

What causes heart failure?

Achieving optimal medical management in HF patients has an effect on outcomes. This article highlights the need for a multidisciplinary approach to heart failure management in the elderly.

Anonymous Patient Answer

Has treatment proven to be more effective than a placebo?

Exercise training and a regular diet have a significant positive effect on cardiac function or survival. Findings from a recent study shows that treatment has little or no effect on long-term improvement from exercise training in HF patients, which is supported by the results of other studies, while other trials have shown that pharmacological treatment with ACE inhibitors or angiotensin receptor blockers is beneficial in HF sufferers.

Anonymous Patient Answer

Have there been any new discoveries for treating heart failure?

There has been a lot of work done to see if there is any improvement in the drugs and the treatments that are used for heart failure, so there is always new developments and new treatments being discovered on a regular basis. There is also the use of heart failure models - Animals and Human Heart Failure models have been developed and are gaining popularity. It is proving to be a practical way to identify new heart failure treatments, but more research will need to be done to determine which drugs will actually work in the real world.

Anonymous Patient Answer

What does treatment usually treat?

The impact on the patient is considerable and can include a major change in lifestyle which may not be possible for younger patients. It is important, however, to emphasise that the primary role of treatment is to prevent further deterioration and to slow or halt the progression of disease.

Anonymous Patient Answer

What is treatment?

Exercise-based lifestyle and medications may be effective in some of the patients with heart failure. We want to encourage them to participate in programs in their areas and take part in this treatment, so that they can regain the power of their hearts.

Anonymous Patient Answer

What is the latest research for heart failure?

The treatments with beta blockers, ACE inhibitors and aldosterone antagonists should be evaluated in patients with heart failure who receive cardiac resynchronization therapy (CRT) and other treatment options should be tested, with more studies needed in order to clarify the optimal therapy for patients with heart failure.

Anonymous Patient Answer

Have there been other clinical trials involving treatment?

While there were limitations with the study, this review highlights several limitations common to many clinical trials evaluating cardioprotective agents. Results from a recent paper of this trial should prompt researchers to evaluate in a larger study the efficacy and effectiveness of N-acetylcysteine in these patients.

Anonymous Patient Answer
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