WithdrawnNot Applicable

Cardiopulmonary Interactions in Patients With Heart Failure

Stopped: Study was considered not useful and competing with another study in clinical context

Germany0Started 2017-07-01

Plain-language summary

This study aims to evaluate cardiopulmonary interactions in patients with heat failure

Who can participate

Age range

40 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 * Written informed consent prior to initiation of any study-mandated procedures * Male or female ≥40 years at screening * Confirmed diagnosis of HFpEF (Heart failure with preserved ejection fraction), HFmrEF (heart failure with mid range ejection fraction) or HFrEF (Heart failure with reduced ejection fraction) in New York Heart Association (NYHA) Functional Class II, III or IV Exclusion criteria * Significant lung disease according to the judgment of the investigator; as a rule, the total lung capacity (TLC) should be \>70% of the predicted value and the forced expiratory volume in 1 second (FEV1) should be \>60% of the predicted value * Significant co-morbidities expected to limit life expectancy to less than 2 years, according to the judgment of the investigator

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.

What they're measuring

Pulmonary Function in Heart failure

Timeframe: Every Year up tp 36 months

Relationship DLCO and hemodynamics

Timeframe: Every year up to 36 months, hemodynamics are not mandatory

Risk factors for a low DLCO

Timeframe: Baseline, Phone visit every 6 months up to 36 months

Impact of LVAD (left ventricular assist device) implantation on lung function

Timeframe: LVAD implantation, 6 months after LVAD implantation, LVAD explantation, 6 months after LVAD explantation, and yearly up to 36 months

Predictors of survival and heart-failure related hospitalisations

Timeframe: Baseline, 1 year, Phone visit every 6 months, up to 36 months

Trial details

NCT IDNCT03317314

SponsorHannover Medical School

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-12-31

View on ClinicalTrials.gov More Heart Failure trials