Cardiopulmonary Interactions in Patients With Heart Failure

Cardiopulmonary Interactions in Patients With Heart Failure (Kardio-pulmonale Interaktionen Bei Patienten Mit Linksherzerkrankungen)

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

Study Overview

• Status: Withdrawn
• Conditions: Heart Failure; Pulmonary Hypertension; Heart Failure With Reduced Ejection Fraction; Heart Failure With Normal Ejection Fraction
• Intervention / Treatment: Diagnostic test: Lung Biopsy during LVAD Implantation

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• Germany
  • Lower Saxony
    • Hannover, Lower Saxony, Germany
      • Hannover MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Male or female patients with heart failure ≥40 years at screening.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Investigators: Principal Investigator: Karen M Olsson, PD Dr. med., Hannover MS

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: July 5, 2017
• First Submitted That Met QC Criteria: October 19, 2017
• First Posted (Actual): October 23, 2017

Study Record Updates

• Last Update Posted (Actual): May 12, 2022
• Last Update Submitted That Met QC Criteria: May 8, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Heart Failure; Hypertension, Pulmonary
• Other Study ID Numbers: Nr. 7155

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No