Heart FailureNCT03317314
Cardiopulmonary Interactions in Patients With Heart Failure
An observational study of Heart Failure and Pulmonary Hypertension, run by Hannover Medical School at 1 site in Germany.
Trial summary
This study aims to evaluate cardiopulmonary interactions in patients with heat failure Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Heart Failure, Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Lung Biopsy during LVAD Implantation
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2017to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male or female patients with heart failure ≥40 years at screening.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Heart Failure, Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction, Heart Failure With Normal Ejection Fraction
- Being tested
- Lung Biopsy during LVAD Implantation
- Medical subject headings
- Heart Failure, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Biopsy during LVAD ImplantationDiagnostic test
Lung Biopsy during LVAD Implantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Function in Heart failure
Pulmonary Function including DLCO (diffusion capacity of the lungs for carbon monoxide)
Measured: 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
Measured: Every year up to 36 months, hemodynamics are not mandatory
Risk factors for a low DLCO
Obtain risk factors for a low DLCO
Measured: 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
Measured: 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
Measured: Baseline, 1 year, Phone visit every 6 months, up to 36 months
Secondary outcomes (1)
Morphometric data of the pulmonary capillary bed
- 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start1 Jul 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Why it stopped: Study was considered not useful and competing with another study in clinical context
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Olsson, PD Dr., Hannover Medical School
- Investigators
- Karen M Olsson, PD Dr. med., Principal investigator, Hannover MS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317314
- Sponsor's protocol ID
- Nr. 7155
- Status last verified
- May 2022
- First submitted
- 5 Jul 2017
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26874383
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Interactions in Patients With Heart Failure (Kardio-pulmonale Interaktionen Bei Patienten Mit Linksherzerkrankungen)
- ClinicalTrials.gov ID
- NCT03317314
- Acronym / sponsor ID
- Nr. 7155
- Conditions
- Heart Failure, Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction, Heart Failure With Normal Ejection Fraction
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study was considered not useful and competing with another study in clinical context
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female patients with heart failure ≥40 years at screening.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung Biopsy during LVAD ImplantationLung Biopsy during LVAD Implantation | Diagnostic test | – |
Primary outcome
Pulmonary Function in Heart failure
Time frame: Every Year up tp 36 months
Pulmonary Function including DLCO (diffusion capacity of the lungs for carbon monoxide)
Relationship DLCO and hemodynamics
Time frame: Every year up to 36 months, hemodynamics are not mandatory
To study the relationship between DLCO, KCO (diffusion capacity per unit alveolar volume) and hemodynamics in patients with heart failure
Risk factors for a low DLCO
Time frame: Baseline, Phone visit every 6 months up to 36 months
Obtain risk factors for a low DLCO
Impact of LVAD (left ventricular assist device) 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
Impact of LVAD implantation on lung function
Predictors of survival and heart-failure related hospitalisations
Time frame: Baseline, 1 year, Phone visit every 6 months, up to 36 months
Predictors of survival and heart-failure related hospitalisations
1 secondary outcome
Morphometric data of the pulmonary capillary bed
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Background: PubMed 26874383Hoeper 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen M Olsson, PD Dr. med. principal investigator
Hannover MS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Pulmonary Hypertension, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Function in Heart failure (time frame: Every Year up tp 36 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03317314, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.