Dilated CardiomyopathyNCT03893760
Assessment of Right Ventricular Function in Advanced Heart Failure
An observational study of Dilated Cardiomyopathy and Heart Failure, run by ITAB - Institute for Advanced Biomedical Technologies at 2 sites in Italy.
Trial summary
We examined the feasibility and reliability of a combined echocardiographic and right heart catheterization (RHC) approach for right ventriculo/arterial (R-V/A) coupling assessment in HF patients with dilated cardiomyopathy (D-CMP). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dilated Cardiomyopathy, Heart Failure
- What is being tested?
- Ventriculo-arterial coupling assessment (R-V/A)
- How many people
- 60 participants
- Where
- 2 sitesItaly
- Study dates
- Oct 2016to Jun 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants underwent the exams in the context of heart-transplant or advanced HF evaluation.
Who may be able to join
- 18 years old
- Given informed consent
- D-CMP
- New York Heart Association (NYHA) functional class II or III
- Reduced EF (≤ 35%)
Who cannot join
- Missing the inclusion criteria
- Refused informed consent
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
University "G. d'Annunzio"
Chieti, 66100
Niguarda Great Metropolitan Hospital
Milan
About this study
Official title: Assessment of Right Ventricular Function in Advanced Heart Failure: Feasibility and Reliability of Right Ventricular Elastance
We examined the feasibility and reliability of a combined echocardiographic and right heart catheterization (RHC) approach for right ventriculo/arterial (R-V/A) coupling assessment in HF patients with dilated cardiomyopathy (D-CMP).
Read the detailed description
This is a single center, retrospective cross-sectional study. In 2016-17, for 6 months, we evaluated for eligibility 81 consecutive D-CMP patients afferent to "Niguarda Great Metropolitan Hospital" for RHC and echocardiography. All participants underwent the exams in the context of heart-transplant or advanced HF evaluation. Inclusion criteria were: 18 years old, given informed consent, D-CMP, New York Heart Association (NYHA) functional class II or III and reduced EF (≤ 35%). On the contrary, exclusion criteria were: missing the inclusion criteria and refused informed consent. The final sample consisted of 68 study participants (mean age 64±7 years, 82 % male).
- Conditions
- Dilated Cardiomyopathy, Heart Failure
- Being tested
- Ventriculo-arterial coupling assessment (R-V/A)
- Keywords
- heart Failure, ventricular elastance, dilated cardiomyopathy, right heart systolic function, right ventriculo-arterial coupling
- Medical subject headings
- Cardiomyopathy, Dilated, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventriculo-arterial coupling assessment (R-V/A)Diagnostic test
R-V/A was achieved by computing the R-Elv/P-Ea ratio (Right ventricular elastance/Pulmonary arterial elastance). R-Elv was computed as PAPm / end-systolic area (ESA) of the right ventricle. P-Ea was obtained as (PAPm-PCWP)/ right ventricle stroke volume (R-SV).
| Study group | Role | What they receive |
|---|---|---|
| No Pulonary Hypertension | the presence of mean pulmonary pressures (PAPm) at the right heart catheterization < 25 mmHg Receives: Diagnostic Test: Ventriculo-arterial coupling assessment (R-V/A) | |
| Postcapillary Pulmonary Hypertension | PAPm ≥ 25 mmHg and postcapillary wedge pressure (PCWP) >15 mmHg Receives: Diagnostic Test: Ventriculo-arterial coupling assessment (R-V/A) | |
| combined postcapillary/precapillary Pulmonary Hypertension | PAPm ≥ 25 mmHg, PAWP >15 mmHg and diastolic peak gradient (DPG - diastolic pulmonary pressure - PCWP) ≥7 mmHg and/or pulmonary vascular resistence (PVR) >3 WU, where available. Receives: Diagnostic Test: Ventriculo-arterial coupling assessment (R-V/A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with altered Right ventriculo/arterial (R-V/A) coupling over PAPm and Pulmonary Hypertension types
Significant correlations and augmentation over PAPm and Pulmonay Hypertension
Measured: up to 24 weeks
Secondary outcomes (1)
Rate of agreement in Right ventriculo/arterial (R-V/A) coupling assessment
Two independent physicians, both experts in echocardiography, independently re-examined 40 studies, randomly selected from all the acquired echocardiographic images. In order to test the R-V/A coupling interobserver agreement
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study startOct 2016
- Primary completionMar 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated CardiomyopathyStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- ITAB - Institute for Advanced Biomedical Technologies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Bianco, ITAB - Institute for Advanced Biomedical Technologies
- Investigators
- Francesco Bianco, MD, Principal investigator, Institute of Cardiology - University "G. d'Annunzio" - Chieti, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893760
- Sponsor's protocol ID
- NGCH001
- Status last verified
- Mar 2019
- First submitted
- 26 Mar 2019
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Right Ventricular Function in Advanced Heart Failure: Feasibility and Reliability of Right Ventricular Elastance
- ClinicalTrials.gov ID
- NCT03893760
- Acronym / sponsor ID
- NGCH001
- Conditions
- Dilated Cardiomyopathy, Heart Failure
- Keywords
- heart Failure, ventricular elastance, dilated cardiomyopathy, right heart systolic function, right ventriculo-arterial coupling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- ITAB - Institute for Advanced Biomedical TechnologiesUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 28 Mar 2019 (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.
We examined the feasibility and reliability of a combined echocardiographic and right heart catheterization (RHC) approach for right ventriculo/arterial (R-V/A) coupling assessment in HF patients with dilated cardiomyopathy (D-CMP).
Detailed description
This is a single center, retrospective cross-sectional study. In 2016-17, for 6 months, we evaluated for eligibility 81 consecutive D-CMP patients afferent to "Niguarda Great Metropolitan Hospital" for RHC and echocardiography. All participants underwent the exams in the context of heart-transplant or advanced HF evaluation. Inclusion criteria were: 18 years old, given informed consent, D-CMP, New York Heart Association (NYHA) functional class II or III and reduced EF (≤ 35%). On the contrary, exclusion criteria were: missing the inclusion criteria and refused informed consent. The final sample consisted of 68 study participants (mean age 64±7 years, 82 % male).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Pulonary Hypertension | – | Diagnostic Test: Ventriculo-arterial coupling assessment (R-V/A)the presence of mean pulmonary pressures (PAPm) at the right heart catheterization < 25 mmHg |
| Postcapillary Pulmonary Hypertension | – | Diagnostic Test: Ventriculo-arterial coupling assessment (R-V/A)PAPm ≥ 25 mmHg and postcapillary wedge pressure (PCWP) >15 mmHg |
| combined postcapillary/precapillary Pulmonary Hypertension | – | Diagnostic Test: Ventriculo-arterial coupling assessment (R-V/A)PAPm ≥ 25 mmHg, PAWP >15 mmHg and diastolic peak gradient (DPG - diastolic pulmonary pressure - PCWP) ≥7 mmHg and/or pulmonary vascular resistence (PVR) >3 WU, where available. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants underwent the exams in the context of heart-transplant or advanced HF evaluation.
Key inclusion criteria (5 listed)
- 18 years old
- Given informed consent
- D-CMP
- New York Heart Association (NYHA) functional class II or III
- Reduced EF (≤ 35%)
Key exclusion criteria (2 listed)
- Missing the inclusion criteria
- Refused informed consent
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 |
|---|---|---|
| Ventriculo-arterial coupling assessment (R-V/A)R-V/A was achieved by computing the R-Elv/P-Ea ratio (Right ventricular elastance/Pulmonary arterial elastance). R-Elv was computed as PAPm / end-systolic area (ESA) of the right ventricle. P-Ea was obtained as (PAPm-PCWP)/ right ventricle stroke volume (R-SV). | Diagnostic test | No Pulonary Hypertension, Postcapillary Pulmonary Hypertension, combined postcapillary/precapillary Pulmonary Hypertension |
Primary outcome
Number of Participants with altered Right ventriculo/arterial (R-V/A) coupling over PAPm and Pulmonary Hypertension types
Time frame: up to 24 weeks
Significant correlations and augmentation over PAPm and Pulmonay Hypertension
1 secondary outcome
Rate of agreement in Right ventriculo/arterial (R-V/A) coupling assessment
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- 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.
Francesco Bianco, MD principal investigator
Institute of Cardiology - University "G. d'Annunzio" - Chieti, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dilated Cardiomyopathy and Heart Failure, run by ITAB - Institute for Advanced Biomedical Technologies at 2 sites in Italy.
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 5 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: finished, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants with altered Right ventriculo/arterial (R-V/A) coupling over PAPm and Pulmonary Hypertension types (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2019.