Interval Training and Hormones in Chronic Heart Failure (NCT02322034) | Clinical Trial Compass
UnknownNot Applicable
Interval Training and Hormones in Chronic Heart Failure
Italy80 participantsStarted 2015-01
Plain-language summary
The investigators aim at investigating whether 24-week high intensity interval training might exert beneficial effects by modulating neurohormonal axis in patients with chronic heart failure (CHF). Furthermore, the effect of detraining on neurohormonal axis in CHF patients will be evaluated.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Stable New York Heart Association (NYHA) class II or III
* Resting left ventricular ejection fraction below 40%
* Measured peak VO2 below 14 ml/kg/min \[Patients must be stable on prescribed cardiac medication for 1 month prior to entering the study\]
Exclusion Criteria:
* myocardial infarction within 12 months prior to study entry;
* unstable angina; resting systolic blood pressure above 200 mmHg, or diastolic blood pressure above 110 mmHg;
* fever of unknown significance;
* critical aortic stenosis (peak systolic pressure gradient \> 50 mm Hg with an aortic valve orifice area \< 0.75 cm2 in average size adult);
* uncontrolled atrial or ventricular arrhythmias such as uncontrolled sinus tachycardia (\> 120 beats.min-1);
* II or greater atrio-ventricular block;
* active pericarditis or myocarditis;
* recent embolism and thrombophlebitis;
* uncontrolled diabetes HbA1C%\>9.5%;
* severe orthopedic or other medical conditions that would prohibit exercise;
* metabolic conditions such as acute thyroiditis, hypokalemia or hyperkalemia and hypovolemia;
* severe renal dysfunction (i.e. creatinine plasma levels \>2.5 mg/dl);
* severe concomitant non-cardiac diseases such as cancer, dementia or any systemic disease limiting exercise;
* inability to participate in a prospective study for any logistic reason
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.