Recruiting

Heart Failure Coaching

Sponsor:

University of Nebraska

Code:

NCT05784753

Conditions

HFpEF - Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

HEART Camp

HEART Camp Connect

Study Details

Brief summary:

The goal of this study is to learn more about patients with heart failure with preserved ejection fraction (HFpEF) and exercise. Investigators want to see if meeting with a coach in person or by video conference will help these patients exercise, feel better, and change markers in their blood. Participants will be randomly placed in one of three groups for 18 months. All groups will have access to a fitness center and be given a watch and heart rate monitor to wear during exercise. The usual care group (control group) will have access to exercise videos via the medical fitness center and will not meet with a coach. The HEART Camp group will exercise and meet with their coach in-person at the medical fitness center. The HEART Camp Connect group will have access to exercise videos via the medical fitness center and will meet with their coach via videoconferencing. All participants will take part in an exercise test and study training prior to being randomized. At four data collection time points, participants will wear an activity monitor for 7 days each, have their blood drawn, and answer questions related to heart failure and exercise. Participants will also wear a heart rate monitor when they exercise and fill out a daily exercise diary.

Conditions

HFpEF - Heart Failure With Preserved Ejection Fraction

Study ID

NCT05784753

Start date

Nov 20, 2023

Status verified date

Jan, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Diagnosis of heart failure with an ejection fraction greater than or equal to 50
  • Echocardiogram in prior 24 months
  • Stable pharmacologic therapy in the past 30 days
  • Any of the following evidence to confirm HFpEF - Score< 6 on Heavy Hypertensive Atrial Fibrillation, Pulmonary Hypertension, Elder, Filling Pressure algorithm, invasive hemodynamic evidence of HFpEF(i.e., elevated pulmonary wedge pressure), or a confirmed clinical diagnosis of HFpEF

Exclusion Criteria:

  • Life-limiting illness precluding study completion
  • Clinical evidence of decompensated heart failure
  • Unstable angina or marked shortness of breath on exertion at less than 2 metabolic equivalents
  • Myocardial infarction, coronary artery bypass graft, or biventricular pacemaker in prior 6 weeks
  • Orthopedic or neuromuscular disorders preventing aerobic exercise
  • Cardiopulmonary exercise test results that preclude safe exercise
  • Unwilling/unable to complete pre-randomization procedures
  • Pregnancy
  • Implantable cardioverter defibrillator

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HEART Camp

Participants in the HEART Camp group will be provided paid, in-person access to the medical fitness center and in-person coaching by a trained coach.

experimental: HEART Camp Connect

Participants in the HEART Camp Connect group will be provided paid, virtual access to the medical fitness center and virtual coaching by a trained coach via videoconference. Participants will also receive automated, asynchronous motivational electronic messaging if they are below the weekly adherence threshold.

no intervention: Enhanced Usual Care

Participants in the Enhanced Usual Care group will be provided paid virtual access to the medical fitness center and virtual availability of the medical fitness center staff and study personnel for participant-initiated questions.

Interventions

HEART Camp

Participants will meet with an in-person coach at the medical fitness center: Months 1-3 weekly for 30 minutes; Months 4-12 every other week for 15 minutes (on alternate weeks, participants will attend a 1-hour group-based exercise training and coaching).

HEART Camp Connect

Participants will meet with a virtual coach from the medical fitness center via videoconferencing: Months 1-3 weekly for 30 minutes; Months 4-12 every other week for 15 minutes (on alternate weeks, participants will attend a virtual 1-hour group-based exercise training and coaching session via videoconferencing).

Primary outcome measure

  • Exercise Adherence [ Time Frame: 6 months ]
  • Exercise Adherence [ Time Frame: 12 months ]
  • Exercise Adherence [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Windy W Alonso, PhD

402-559-8342windy.alonso@unmc.edu

Locations

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 49201

Contacts

Steven Keteyian, PhD

sketeyi1@hfhs.org

Crystal Grimshaw

cgrimsh1@hfhs.org

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198-5330

Contacts

Bunny Pozehl, PhD, RN

402-559-8342bpozehl@unmc.edu

Tiffany Dudley

tiffany.dudley@unmc.edu

More Information

Sponsor

University of Nebraska

Last update posted

Jan 16, 2026

Last verified

Jan, 2026

Keywords

  • exercise training
  • patient adherence
  • coaching

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Nebraska on 2026-01-16.