Effect of Home Rehabilitation on State of Patients With PAH, HFREF and IHD (NCT03780803) | Clinical Trial Compass
CompletedNot Applicable
Effect of Home Rehabilitation on State of Patients With PAH, HFREF and IHD
Poland93 participantsStarted 2016-02-01
Plain-language summary
The aim of the study is to evaluate the influence of physical training and respiratory rehabilitation performed by patients at home on quality of life, symptoms, physical endurance, force of respiratory and skeletal muscles and body mass composition in patients with pulmonary arterial hypertension (PAH) or left ventricular heart failure with reduced ejection fraction - HFREF), or ischemic heart disease and evaluation the number of stem cells, natural lymphoid cells and distribution of subpopulations of monocytes (including proangiogenic monocytes) in examined persons and evaluation of theirs eventual influence of the course of disease.
Who can participate
Age range
18 Years
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:
* age \>18 years
* informed consent signed by patient to conduct the study
* no diseases excluding rehabilitation
* pts with idiopathic, inherited PAH (pulmonary arterial hypertension), or in the course of connective tissue diseases, portal hypertension, congenital heart diseases.
* PAH confirmed in catheterisation of right side of heart mPAP (mean pulmonary arterial pressure) ≥25 mmHg, PCWP (pulmonary capillary wedge pressure) ≤15mmHg.
* Chronic heart failure - left ventricle ejection fraction \<40% in echocardiography, NYHA \*New York Health Association) class II-III
* stable ischaemic heart disease in CCS (Canadian Cardiovascular Society) class II-III
Exclusion Criteria:
* Other types of pulmonary hypertension
* COPD (chronic obstructive pulmonary disease), asthma
* malignancies
* Acute inflammatory state up to 4 weeks before inclusion to the study
* Acute coronary syndrome up to 3 months before inclusion to the study
* Heart failure in NYHA IV class
* severe anaemia (Hgb \<11g/dl for men \<10g/dl for women)
* electrolyte and hormonal disturbances in period of 1 month before inclusion to the study
* substantial modification of treatment of main disease within last 3 months
* ischaemic heart disease in CCS class IV
* Other clinical situations excluding to perform controlled program of rehabilitation
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.