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 function in individuals with heart failure.

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About the trial for Heart Failure

Eligible Conditions
Hearth Failure With Reduced Ejection Fraction (HFrEF) · 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 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
NYHA Class I, II or III heart failure
EF≤40 percent within the past year
An implantable cardioverter-defibrillator (ICD)
Stable doses of neurohormonal blockade for 30 days
TSH and free T4 level within the laboratory reference range and total T3 level <94 ng/dL
Men and women aged ≥18 years
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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
Measure of Quality of Life
8 WEEKS
Change in Kansas City Cardiomyopathy Questionnaire, KCCQ
8 WEEKS
T3 Level
8 WEEKS
Percentage of participant T3 levels above upper limit of reference range
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
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.

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

The number of new cases of HF in the USA is growing faster than the population is growing. People are living longer than ever before, and this phenomenon will increase the burden on the heart, more than ever before.

Anonymous Patient Answer

What are common treatments for heart failure?

A broad variety of treatments have been recommended to most patients with heart failure. These treatments are often based on patient preferences and values as well as expertise and knowledge from the expert panel. Clinicians can implement evidence-based treatment in a clinical practice.

Anonymous Patient Answer

What causes heart failure?

Heart failure has no known single obvious cause. The underlying mechanisms that lead to heart failure are quite complex and are likely due to multiple factors. Most heart failure happens when cells in the heart, such as cardiomyocytes start breaking down and dying. While we cannot know for sure, it is likely that heart failure is a group of diseases with different causes. A heart failure epidemic may occur, with many different causes contributing to the condition.\n

Anonymous Patient Answer

What is heart failure?

Heart failure is a condition in which parts of the heart stop working smoothly and fail to pump blood effectively. It is associated with shortness of breath, swelling of the legs, increased fluid in the legs and abdomen (fluid retention), and tiredness. The symptoms may be episodic or constant. These symptoms may improve or worsen over time and can be more severe when exercising, when lying down, with standing up, and during waking hours than during sleep. Symptoms such as dizziness, shortness of breath, and fluid in the lower legs (fluid retention) are the key symptoms of heart failure. Many people with a diagnosis of heart failure go on to have heart attacks (myocardial infarction).

Anonymous Patient Answer

What are the signs of heart failure?

Symptoms of heart failure include shortness of breath, heaviness, coughing, and/or tiredness. Other signs include poor appetite, fluid in the chest, swollen legs, leg cramps, and swelling. The symptoms and signs most common in heart failure are similar between men and women.\nquestion: What is the diagnosis of depression? answer: The assessment of signs and symptoms in depression may lead to the differential diagnosis of common conditions, including major anxiety and somatoform disorders, endocrine disorders, sleep disorders, and endocrine illnesses such as hypothyroidism and Cushing's disease.

Anonymous Patient Answer

Can heart failure be cured?

Treatment of heart failure remains largely unsatisfactory in terms of symptoms and life quality. However, many of the problems are partially manageable to some extent, in the form of new symptomatic and symptomatic treatments. Consequently, most individuals need help in order to improve their state of health. There is need for improved pharmacological and medical device therapies and better medical management of the cardiovascular system.

Anonymous Patient Answer

Have there been any new discoveries for treating heart failure?

There were many recent studies proving that pharmacotherapy is effective for heart failure. However, there has not been a study that demonstrated pharmacotherapy was an absolute cure for heart failure. Instead, many studies showed that the treatment was effective, with a substantial improvement in the patients' HRQoL. However, to have a treatment with a large effect on the survival, the patient compliance with the new pharmacotherapy should be ensured.

Anonymous Patient Answer

Who should consider clinical trials for heart failure?

Although there was some variability among individual physicians, the majority of practicing physicians, nurses, and patient participants were eager for clinical trial participation in a variety of HF therapeutic areas. Clinicians felt it would be important to include patients and providers in studies, and the majority felt there were ethical dilemmas regarding clinical trial participation in HF.

Anonymous Patient Answer

What is the latest research for heart failure?

The majority of studies found in this review were of low-quality and had many limitations. However, the studies that were included suggested that in all patients with symptoms or New York Heart Association class IV or unstable heart failure, transcatheter cardiac stenting with the objective of reducing morbidity is a reasonable treatment option. For asymptomatic patients in New York Heart Association class III, with either poor left ventricular function or with a low ejection fraction, a heart transplant surgery has not been shown to be safe or helpful.

Anonymous Patient Answer

What is the primary cause of heart failure?

Cardiovascular disease is the most common primary cause of heart failure. However, in patients with mild heart failure, there is no demonstrable difference in the primary cause of heart failure compared to the non-heart failure group. A further prospective study for elucidating the primary cause of heart failure is clearly indicated.

Anonymous Patient Answer

What is the average age someone gets heart failure?

The estimated average heart failure ages in Germany are 75 years for men and 80 years for women. On the other hand, in England, women get heart failure about a year earlier than men.

Anonymous Patient Answer

How serious can heart failure be?

In the most common clinical presentations (NYHA II), it is difficult to predict how serious heart failure will become. As such, patients not responding to optimal medical care will be best served if an assessment of prognosis is performed in the initial presentation in addition to determining the clinical presentation and results of the echocardiogram. Such an approach will allow for optimal referral and resource utilization since patients will be assessed prior to being referred to the appropriate specialty and the potential need for subsequent intervention will be more obvious. The clinical presentation and results of the echocardiogram allows for the prioritization of which patients may benefit from referral to an advanced care facility.

Anonymous Patient Answer
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