Boosted exercise with group coaching for HFpEF

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study combines supervised aerobic exercise with group-mediated behavioral support and remote activity-tracking to improve adherence and outcomes in older adults with HFpEF. It uses two sequential waves to refine the program and assess feasibility and impact. Participants are adults aged 55 and older with HFpEF and certain functional limitations, recruited at Wake Forest University Health Sciences. The design emphasizes behavior change, resource optimization, and real-world applicability of the exercise intervention.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of heart failure with signs and symptoms of heart failure and at least one of the following: Evidence of increased LV filling pressures at rest, exercise, or other provocations / Prior HF hospitalization / Elevated heart Failure with Preserved Ejection Fraction (H2FPEF) score or elevated Heart Failure Association-Pre-test, Echocardiography \& natriuretic peptide, Functional testing, Final etiology (HFA-PEFF) score
* Left ventricular ejection fraction ≥ 50%
* New York Heart Association (NYHA) functional class II-IV
* Age ≥ 55 years old

Exclusion Criteria:

* Significant change in cardiac medication or heart failure (HF) symptoms within 3 weeks prior to enrollment
* Hospitalization or urgent care visit for HF within 4 weeks prior to enrollment
* Acute coronary syndrome, stroke, transient ischemic attack; cardiac, carotid or other major Cardiac Vascular (CV) surgery; percutaneous coronary intervention (PCI) or carotid angioplasty, within 30 days prior to enrolment
* Uncontrolled hypertension
* Recent or debilitating stroke
* Severe pulmonary disease including chronic obstructive pulmonary disease (COPD)
* Hemoglobin (Hgb) \< 9.5 g/dL males and \< 9 g/dL females within 30 days prior to enrollment
* Patients with a history of heart transplant or Left Ventricular Assist Device (LVAD), currently on the transplant list
* Significant, unrepaired cardiac valvular disease
* A non-cardiac medical condition with an estimated life expectancy of \< 12 months
* Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy including amyloid heart disease (amyloidosis)
* Life-threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and atrial fibrillation or flutter
* A treadmill exercise test revealing: ischemia; chest pain or leg claudication; exercise Systolic Blood Pressure \> 240 mmHg, Diastolic Blood Pressure \> 110 mmHg; unstable hemodynamics or rhythm; or unwilling or unable to complete adequate exercise test
* Already engaging in regular moderate to vigorous exercise conditioning defined as \>30 minutes per day, ≥twice per week consistently during the previous 6 weeks
* Any condition that in the judgement of the investigator precludes participation in study or study procedures such as significant dementia, mobility impairment, uncontrolled psychiatric disease, etc.
* Inability to meet the expectations of the intervention (i.e., excessive distance from facility, work conflict with intervention)

Where it's running

• Wake Forest University Health Sciences
  Winston-Salem, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Anthony E Peters, MD — Wake Forest University Health Sciences
• Study coordinator: Anthony E Peters, MD
• Email: Anthony.Peters@advocatehealth.org
• Phone: 336-713-2278

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Remote rehabilitation for HFpEF patients using telerehabilitation

  A home-based telerehabilitation program is being tested to see if it is safe and helpful for people with heart failure with preserved ejection fraction.

  Recruiting at 3 sites American Heart of Poland · Chrzanów and 2 other locations · NCT07918209

• EDG-15400 in adults with HFpEF: a phase 2 study

  This phase 2 study tests different doses of EDG-15400 against placebo in adults with HFpEF to see if it is safe and tolerable.

  Recruiting at 4 sites Phase 2 Edgewise Therapeutics, Inc. · Birmingham, Alabama and 27 other locations · NCT07795814

• Incretin therapy with tirzepatide for obesity-related HFpEF

  A 15-month study will test whether tirzepatide helps people with obesity and HFpEF by reducing plasma volume.

  Recruiting Phase 4 Columbia University · New York, New York · NCT07554638

• Exercise cardiac MRI for heart failure with preserved ejection fraction

  This study will try low-field exercise cardiac MRI to see if it can diagnose, describe, and predict risk in people with HFpEF compared with those who have non-cardiac breathlessness and healthy volunteers.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07401771

• HRS-1893 for heart failure with preserved ejection fraction

  This trial will test whether HRS-1893 is safe and tolerable in adults aged 40 and older who have heart failure with preserved ejection fraction.

  Recruiting Phase 2 Shandong Suncadia Medicine Co., Ltd. · Shanghai, Shanghai Municipality · NCT07269717

• Pulmonary Artery Denervation for a specific type of heart and lung pressure problem

  This study tests whether the Enhancor System can safely and effectively help patients with combined pre- and post-capillary pulmonary hypertension due to left heart disease when added to standard therapy.

  Recruiting at 18 sites Pulnovo Medical, Inc. · Tucson, Arizona and 18 other locations · NCT07214376

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.