Personalized remote exercise therapy for heart health

A Multi-center, Investigator-blinded, Randomized, 12-month, Parallel-group, Study to Compare the Clinical and Cost Efficacy of a New Hybrid Exercise Intervention PRIORITY Versus Usual Care

This study is testing a new remote exercise program to see if it can help people at risk of heart failure stay healthier and more active.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 312 (estimated)
• Ages: 30 Years to 85 Years
• Sex: All
• Sponsor: KU Leuven (Academic / other)
• Locations: 3 sites (Antwerp and 2 other locations)
• Trial ID: NCT04745013 on ClinicalTrials.gov

What this trial studies

The PRIORITY initiative aims to establish clinical evidence for a novel hybrid exercise intervention that combines remotely guided home-based exercise with usual care. This approach is designed to prevent the negative effects of sedentary aging on heart health and delay the onset of heart failure with preserved ejection fraction (HFpEF). Participants will be monitored and guided remotely to ensure adherence and effectiveness of the exercise regimen. The study targets individuals at risk of developing HFpEF, including those with hypertension, prediabetes, obesity, and early signs of heart dysfunction.

Who should consider this trial

Good fit: Ideal candidates include men and women over 30 years old with hypertension, prediabetes, obesity, or early signs of heart dysfunction.

Not a fit: Patients with advanced heart failure symptoms or those not on optimal medical treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve heart health and prevent the progression of heart failure in at-risk populations.

How similar studies have performed: Other studies have shown promise in using remote exercise interventions for heart health, suggesting this approach could be effective.

Eligibility criteria

Inclusion Criteria: Men and women (HF stage A) aged \> 30 yrs:

* treated or untreated patients with hypertension (blood pressure 130/80 - 159/99 mmHg) AND/OR
* Patients with prediabetes (impaired fasting glucose and/or insulin resistance) with either:

Fasting plasma glucose: 100 to 125 mg/dL (5.6-6.9 mmol/L) Hemoglobine A1c: 5.7% to 6.4% Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index above 75% of population distribution (\>2.0) AND/OR

* Patients with obesity with 30 kg/m² ≥ body mass index ≤ 42 kg/m²
* Patients with subclinical signs of diastolic dysfunction without symptoms (HF Stage B disease)
* Men and women with diagnosis of HF stage C: i.e. patients who have a total score ≥ 5 points according to the recent recommendation paper on how to diagnose heart failure with preserved ejection fraction from the Heart failure Association of ESC.

All participants should be on optimal medical treatment and stable with regard to symptoms and pharmacotherapy for at least 4 weeks before enrollment in the study. All participants should have internet access at home.

Exclusion Criteria:

* significant illness during the last 6 weeks
* known severe ventricular arrhythmia with functional or prognostic significance
* significant myocardial ischemia, hemodynamic deterioration or exercise-induced arrhythmia at baseline testing
* co-morbidity that may significantly negatively influence one-year prognosis
* functional or mental disability that may limit execution of prescribed exercise
* severe chronic obstructive pulmonary disease (FEV1 \< 50%)
* NYHA class IV
* participation in another clinical interventional trial
* cognitive limitation

Where this trial is running

Antwerp and 2 other locations

• Uza — Antwerp, Belgium (Recruiting)
• Jessa Hospital Hasselt — Hasselt, Belgium (Recruiting)
• UHasselt — Hasselt, Belgium (Recruiting)

Study contacts

• Principal investigator: Véronique Cornelissen, PhD — KU Leuven
• Study coordinator: Véronique Cornelissen, PhD

Conditions Heart Failure With Preserved Ejection Fraction