Clinical Trials Logo

Clinical Trial Summary

This study is trying to find out whether performing a hybrid aerobic-resistance exercise training program (titled PRIME: Peripheral Remodeling via Intermittent Muscular Exercise) results in better health outcomes than the traditional exercise training program (called COMBO) that is used in individuals with heart failure with reduced ejection fraction (HFrEF). Participants will be randomized (like the flip of a coin) to either PRIME (investigational) or the traditional exercise program (standard of care).


Clinical Trial Description

This study is a two-arm, prospective randomized clinical trial with participants randomized, in a 1:1 ratio to 4 weeks of either standard progressive whole-body aerobic plus resistance training (COMBO) or PRIME training (Phase 1), followed by 8 weeks of progressive whole-body COMBO assigned to all participants (Phase 2). The objective of this study is to determine whether PRIME exercise training can outperform traditional (COMBO) exercise training to improve outcomes in HFrEF patients. The study aims to test 92 HFrEF patients (46 randomized to PRIME and 46 to COMBO training) over a 5-year period. Data will be collected at each visit and patients will return for a 6-month follow up from the date of the final visit. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05609097
Study type Interventional
Source University of Virginia
Contact Emily Guy, B.S
Phone 434-243-8677
Email ejg9rb@virginia.edu
Status Recruiting
Phase N/A
Start date April 14, 2023
Completion date March 31, 2027

See also
  Status Clinical Trial Phase
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Completed NCT03614169 - Direct HIS-pacing as an Alternative to BiV-pacing in Symptomatic HFrEF Patients With True LBBB N/A
Recruiting NCT05278962 - HF Patients With LVADs Being Treated With SGLT2i Phase 4
Completed NCT04210375 - Study of JK07 in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF) Phase 1
Not yet recruiting NCT06433687 - Evaluation of the HekaHeart Platform in Medication Management for Heart Failure Patients
Completed NCT05001165 - Dashboard Activated Services and Tele-Health for Heart Failure N/A
Active, not recruiting NCT03701880 - Early Use of Ivabradine in Heart Failure N/A
Recruiting NCT05650658 - Left vs Left Randomized Clinical Trial N/A
Not yet recruiting NCT06299436 - Hemodynamic Assessment of underLying myocyTe Function in Right Heart Failure
Recruiting NCT05992116 - Iron Deficiency in Patients With Heart Failure and Reduced and Mildly Reduced Ejection Fraction
Recruiting NCT05365568 - Left Bundle Branch Area Pacing for Cardiac Resynchronization Therapy: A Randomized Study N/A
Active, not recruiting NCT05204238 - Follow Up of acuTe Heart failUre: a pRospective Echocardiographic and Clinical Study (FUTURE)
Not yet recruiting NCT04420065 - Effects of Preferential Left Ventricular Pacing on Ventriculoarterial Coupling and Clinical Course of Heart Failure N/A
Terminated NCT03479424 - Home Outpatient Monitoring and Engagement to Predict HF Exacerbation
Completed NCT02113033 - VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients Phase 2
Recruiting NCT03209180 - Immediate Release Versus Slow Release Carvedilol in Heart Failure Phase 4
Recruiting NCT05299879 - Screening for Advanced Heart Failure IN Stable ouTpatientS - The SAINTS Study
Recruiting NCT05637853 - Telemonitored Fast Track Medical Sequencing for Heart Failure With Reduced Ejection Fraction
Completed NCT03870074 - CPET Predicts Long-term Survival and Positive Response to CRT
Recruiting NCT04590001 - Effect of the MobiusHD® in Patients With Heart Failure N/A