Cardiovascular Improvements With MV ASV Therapy in Heart Failure (NCT01953874) | Clinical Trial Compass
TerminatedNot Applicable
Cardiovascular Improvements With MV ASV Therapy in Heart Failure
Stopped: SERVE-HF results showed ASV increased CV mortality in patients with reduced LVEF
United States, Germany126 participantsStarted 2013-12
Plain-language summary
The aim of the study is to compare the effects of MV targeted ASV in addition to optimized medical therapy versus optimized medical therapy alone at 6 months in patients with acute decompensated HF. The study will also assess changes in functional parameters, biomarkers, quality of life (QOL), and sleep.
Who can participate
Age range
21 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:
* Patients 21 years or older
* Patients with prior clinical diagnosis of heart failure (HFrEF or HFpEF), or de novo diagnosis of HFpEF indicated by a local BNP≥300 pg/mL or NT pro-BNP≥1200 pg/mL on admission without systolic blood pressure \>180 mmHg or atrial fibrillation, or diagnosis of HFrEF indicated by documented evidence of prescribed beta-blockers and ACE-inhibitors or ARBs for at least 4 weeks prior to admission
* Hospital admission for acute decompensated HF as determined by:
* Dyspnea at rest or with minimal exertion
* AND At least two of the following signs and symptoms:
* Orthopnea
* Pulmonary rales beyond basilar
* Chest congestion on x-ray
* BNP≥300pg/mL or NT pro-BNP≥1200pg/mL
* Pulmonary capillary wedge pressure (PCWP) ≥25mmHg during current hospitalization
* Presented to hospital or clinic at least 24 hours prior to consent
* Patient stable enough to stop oxygen use for duration of polygraphy test or have access to dual lumen cannula for polygraphy test
* Sleep disordered breathing (SDB) documented by polygraphy with an AHI≥15 events/hour
* Patient is able to fully understand study information and sign a consent form
Exclusion Criteria:
* Right-sided heart failure without left-sided heart failure
* Sustained systolic blood pressure \<80 mmHg at baseline
* Acute coronary syndrome within 1 months of randomization
* Active myocarditis
* Complex congenital heart disease
* Constrictive pericarditis
* Non-cardiac pulmonary …
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.