Is NCT05525663 recruiting in Winston Salem, NC?

Yes, NCT05525663 is currently recruiting participants at its Winston Salem, NC location. This heart failure with preserved ejection fraction clinical trial is actively enrolling qualified participants.

Is participation in this Winston Salem clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Heart Failure With Preserved Ejection Fraction Clinical Trial in Winston Salem, NC

Q: How do I join the heart failure with preserved ejection fraction clinical trial in Winston Salem?

To join this clinical trial in Winston Salem, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Heart Failure With Preserved Ejection Fraction Study in Winston Salem

The REHAB-HFpEF trial will determine whether a novel physical rehabilitation intervention will improve the primary outcome of combined all-cause rehospitalizations and mortality and the secondary outcome of major mobility disability during 6-month follow-up in patients hospitalized for heart failure and preserved ejection fraction (HFpEF), which is nearly unique to older persons, and for which there are few treatment options.

Sponsor: Wake Forest University Health Sciences

Who Can Participate

Inclusion Criteria

Age \>=60 years old

Ejection Fraction \>=45%

In the hospital setting \>24 hours for the management of acute decompensated heart failure (ADHF), or diagnosed with ADHF after being hospitalized for another reason. ADHF will be confirmed by the site physician, and will be defined according to the Food and Drug Administration (FDA) definition of hospitalized heart failure as a combination of symptoms, signs, and HF-specific medical treatments, and requires that all 4 of the following are met:

At least 1 symptom of HF which has worsened from baseline: a. dyspnea at rest or with exertion; b. exertional fatigue; c. orthopnea; d. paroxysmal nocturnal dyspnea (PND)

At least 2 of the following signs of HF: a. Pulmonary congestion or edema on physical exam (rales or crackles) or by chest X-ray; b. Elevated jugular venous pressure or central venous pressure \>=10 mm Hg; c. peripheral edema; d. wedge or left ventricular end diastolic pressure \>=15 mmHg; e. rapid weight gain (\>=5 lbs.); f. Increased b-type natriuretic peptide (BNP) (\>=100 pg/ml) or N-terminal prohormone BNP (\>=220pg/ml)

Change in medical treatment specifically targeting HF, defined as change in dose or initiation of or augmentation of at least 1 of the following therapies: a. diuretics; b. vasodilators; c. other neurohormonal modulating agents, including angiotensinconverting enzyme inhibitors, angiotensin II receptor blockers (with or without neprilysin inhibitor), beta-blockers, aldosterone inhibitors, direct renin inhibitors, or sodium-glucose co-transporter-2 inhibitors

The primary cause of symptoms and signs is judged by the investigator to be due to HF

Adequate clinical stability to allow participation in study assessments and the intervention Independent with basic activities of daily living, including the ability to ambulate independently (with or without the use of an assistive device) prior to admission

Able to walk 4 meters (with or without the use of an assistive device) at the time of enrollment

Exclusion Criteria

Acute myocardial infarction within the past 3 months, or planned coronary artery intervention (percutaneous or surgical) within the next 6 months (Note: given that cardiac biomarkers such as troponin are frequently elevated in HF patients, the diagnosis of acute myocardial infarction should be based on clinical diagnosis, not biomarkers alone)

Severe aortic or mitral valve stenosis

Severe valvular heart disease with planned intervention within next 6 months

Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy including amyloid heart disease (amyloidosis)

Planned discharge other than to home or a facility where the participant will live independently

Terminal illness other than HF with life expectancy \<1 year

Impairment from stroke or other medical disorders that preclude participation in the intervention

Known dementia by medical record documentation, OR patients with Montreal Cognitive Assessment (MoCA) \<=18 AND without social support, OR MoCA \<10 regardless of social support

Advanced chronic kidney disease defined as estimated glomerular filtration rate \<20 mL/min/1.73 m2 or on chronic or intermittent dialysis or dialysis anticipated within the next 6 months

Already engaging in regular moderate to vigorous exercise conditioning defined as \>30 minutes per day, \>= twice per week consistently during the previous 6 weeks

Enrollment in a clinical trial not approved for co-enrollment

High risk for non-adherence as determined by screening evaluation

Inability or unwillingness to comply with the study requirements or give consent

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Winston Salem?

Yes, this clinical trial (NCT05525663) has an active research site in Winston Salem, NC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Heart Failure With Preserved Ejection Fraction Treatment Options in Winston Salem, NC

If you're searching for heart failure with preserved ejection fraction treatment options in Winston Salem, NC, this clinical trial (NCT05525663) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Winston Salem research site is actively enrolling participants for this clinical trial. You'll receive care from experienced heart failure with preserved ejection fraction specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all heart failure with preserved ejection fraction clinical trials near you to find additional studies recruiting in your area.

Heart Failure With Preserved Ejection Fraction Clinical Trial in Winston Salem, NC

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