Clinical trial NCT03317314: Cardiopulmonary Interactions in Patients With Heart Failure
Official title: Cardiopulmonary Interactions in Patients With Heart Failure (Kardio-pulmonale Interaktionen Bei Patienten Mit Linksherzerkrankungen)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Heart Failure
Pulmonary Hypertension
Heart Failure With Reduced Ejection Fraction
Heart Failure With Normal Ejection Fraction
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male or female patients with heart failure ≥40 years at screening.

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pulmonary Function in Heart failure
timeFrame: Every Year up tp 36 months
measure: Relationship DLCO and hemodynamics
timeFrame: Every year up to 36 months, hemodynamics are not mandatory
measure: Risk factors for a low DLCO
timeFrame: Baseline, Phone visit every 6 months up to 36 months
measure: 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
measure: Predictors of survival and heart-failure related hospitalisations
timeFrame: Baseline, 1 year, Phone visit every 6 months, up to 36 months
Secondary outcomes:
measure: Morphometric data of the pulmonary capillary bed
timeFrame: 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.
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover MS
state: Lower Saxony
Study officials:
affiliation: Hannover MS
name: Karen M Olsson, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.