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Study was considered not useful and competing with another study in clinical context
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This study aims to evaluate cardiopulmonary interactions in patients with heat failure
Heart failure is one of the most common diseases, especially in ageing populations, affecting ≥10% of persons 70 years of age or older. There is a growing body of evidence that dyspnea in patients with heart failure is not only related to low cardiac output and pulmonary venous congestion, but also to functional and structural alterations of the lungs.Pulmonary hypertension is a well-known complication of heart failure, but recent evidence suggests that the alveolo-capillary membrane is also affected, at least in subgroups of patients with heart failure.
Damage to the alveolo-capillary membrane is reflected by a low diffusion capacity of the lungs for carbon monoxide (DLCO).
In this study we aim to describe the alteration of lung function and obtain morphometric data of the capillary bed of patients with heart failure.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung Biopsy during LVAD Implantation | Diagnostic Test | Lung Biopsy during LVAD Implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Function in Heart failure | Pulmonary Function including DLCO (diffusion capacity of the lungs for carbon monoxide) | Every Year up tp 36 months |
| Relationship DLCO and hemodynamics | To study the relationship between DLCO, KCO (diffusion capacity per unit alveolar volume) and hemodynamics in patients with heart failure | Every year up to 36 months, hemodynamics are not mandatory |
| Risk factors for a low DLCO | Obtain risk factors for a low DLCO | Baseline, Phone visit every 6 months up to 36 months |
| Impact of LVAD (left ventricular assist device) implantation on lung function | Impact of LVAD implantation on lung function | 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 | Predictors of survival and heart-failure related hospitalisations | Baseline, 1 year, Phone visit every 6 months, up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Morphometric data of the pulmonary capillary bed | 1. To obtain morphometric data on the pulmonary microvasculature in patients with heart failure by taking open lung biopsies from patients with heart failure undergoing heart transplantation or LVAD implantation. The morphometric data will be compared with the functional assessments, in particular with DLCO and KCO. | Biopsies are taken once during LVAD implantation, Heart transplantation or LVAD explantation if performed (variable time points) and compared with the functional assessments, in particular with DLCO and KCO up to 36 months. |
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Inclusion criteria
Exclusion criteria
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Male or female patients with heart failure ≥40 years at screening.
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| Name | Affiliation | Role |
|---|---|---|
| Karen M Olsson, PD Dr. med. | Hannover MS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hannover MS | Hanover | Lower Saxony | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26874383 | Background | Hoeper MM, Meyer K, Rademacher J, Fuge J, Welte T, Olsson KM. Diffusion Capacity and Mortality in Patients With Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction. JACC Heart Fail. 2016 Jun;4(6):441-9. doi: 10.1016/j.jchf.2015.12.016. Epub 2016 Feb 10. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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10 ml samples each for storing plasma and serum samples (biobanking)
| D006973 |
| Hypertension |
| D014652 | Vascular Diseases |