Clinical trial for Atrial Fibrillation (AF)
Official title PREACTIVE: Preconditioning Exercise Intervention to Improve Symptoms and Quality of Life in Comorbid Atrial Fibrillation and HFpEF
ClinicalTrials.gov ID: NCT07324772
What this study is testing
- What it's testing
- The study wants to see if this sequential exercise plan can reduce symptoms, improve how people feel, and make daily activities easier for those with AF and HFpEF.
- Who it's for
- Adults who have atrial fibrillation (paroxysmal or persistent) and heart failure with preserved ejection fraction.
- What's involved
- Participants will do a series of resistance‑strength workouts followed by aerobic exercise, with scheduled visits and health tests to track progress.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 99
You may be able to join if
- Ejection fraction ≥ 50%
- E/e' ≥15 by Doppler Echocardiography
- High H2FpEF score (≥5)
- Must be in stable medical condition and able to begin an exercise program
You likely can't join if
- Valvular heart disease as the primary etiology of heart failure (i.e., severe aortic stenosis or mitral regurgitation),
- New York Heart Association Stage IV
- Recent stroke (\<1 year)
- Evidence or History of Cardiac amyloidosis
- Patients with persistent AF and poor rate control (HR \> 110 at rest)
- Significant change in cardiac medication or Heart Failure symptoms \< 2 weeks
See the full eligibility criteria
- Ejection fraction ≥ 50%
- E/e' ≥15 by Doppler Echocardiography
- High H2FpEF score (≥5)
- Must be in stable medical condition and able to begin an exercise program
- Valvular heart disease as the primary etiology of heart failure (i.e., severe aortic stenosis or mitral regurgitation),
- New York Heart Association Stage IV
- Recent stroke (\<1 year)
- Evidence or History of Cardiac amyloidosis
- Patients with persistent AF and poor rate control (HR \> 110 at rest)
- Significant change in cardiac medication or Heart Failure symptoms \< 2 weeks
- Unstable or severe angina not controlled during daily activity by pharmacological therapy or at \<4 METS activity
- Uncontrolled hypertension (defined as systolic blood pressure \>200 mm Hg and/or diastolic blood pressure\>110 mm Hg) with medications
- Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
- Hospitalization or urgent care visit \< 4 weeks
- Oxygen dependent Chronic Obstructive Pulmonary Disease (COPD)
- Significant anemia (\<10 g/dL Hgb)
- End stage renal replacement therapy associated with the need for dialysis
- Active treatment for cancer defined as current radiation, chemotherapy, immunotherapy, or cancer recurrence within past 5 years
- Hospice care and indication of life expectancy less than 2 years
- Complete dependence confinement to a Wheelchair confinement or requiring a visual impairment or Orthopedic or severe musculoskeletal conditions that would prohibit resistance training or aerobic exercise.
- Physician diagnosed Alzheimer's disease or Dementia or bipolar or psychotic disorder; Montreal Cognitive Assessment (MoCA) is ≤ 18 (based on participant screening)
- High levels of physical functioning based the composite short physical performance battery score of ≥10 (out of 12)
- Planned major surgery, coronary or leg revascularization during the next six months
- Participation in a supervised exercise program or already engaging in regular exercise
- Plans to transfer care outside of NU within the study period
- Unable to consent or commit to requires study procedures
- Non-English speaking
The study team makes the final eligibility decision.
Where it is enrolling
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chicago, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.