Cardiopulmonary Interactions in Patients With Heart Failure

NCT03317314 | Withdrawn

• 1 other identifier: Nr. 7155
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Morphometric data of the pulmonary capillary bed

  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.

Interventions

Lung Biopsy during LVAD Implantation DIAGNOSTIC_TEST

Lung Biopsy during LVAD Implantation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Hannover MS

Hanover, Lower Saxony, Germany

Location

Related Publications (1)

• 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.

  PMID: 26874383 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

10 ml samples each for storing plasma and serum samples (biobanking)

MeSH Terms

Conditions

Heart Failure; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases

Study Officials

• Karen M Olsson, PD Dr. med.

  Hannover MS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med. Karen Olsson

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: October 23, 2017
• Study Start: July 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: May 12, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)