Cardiopulmonary Interactions in Patients With Heart Failure

Hannover Medical School

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Heart Failure Pulmonary Hypertension Heart Failure With Reduced Ejection Fraction Heart Failure With Normal Ejection Fraction

Interventions

Lung Biopsy during LVAD ImplantationDIAGNOSTIC_TEST

Lung Biopsy during LVAD Implantation

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Hannover MS

Hanover, Lower Saxony, Germany

Outcomes

Primary Outcomes

Pulmonary Function in Heart failure

Pulmonary Function including DLCO (diffusion capacity of the lungs for carbon monoxide)

Time frame: 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

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

Risk factors for a low DLCO

Obtain risk factors for a low DLCO

Time frame: 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

Time frame: 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

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

Secondary Outcomes

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.

Time frame: 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.

Data from ClinicalTrials.gov

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