Pulmonary HypertensionUVRVNCT03935178

Evaluating Right Ventricular (RV) Size and Function Using the Upper Valley RV Algorithm and Novel Imaging Modalities

An observational study of Pulmonary Hypertension and Valvular Heart Disease, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The primary purpose of this study is to evaluate the diagnostic performance of three methods for measuring right ventricular size and function including the Philips Novel RV quantification technologies (RV Heart Model volumetric analysis and Philips 2D strain) and the Upper Valley Right Ventricle Algorithm (UVRV)… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Hypertension, Valvular Heart Disease, Congenital Heart Disease
What is being tested?: Measuring Right Ventricular Size and Function
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 5 Aug 2019to 30 Jan 2022
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
No healthy volunteers
Adult, Older adult

Study population: This study is for people who are18-years or older that are undergoing cardiac magnetic resonance imaging (CMR) as a standard of care at Dartmouth-Hitchcock Medical Center in Lebanon, NH.

Who may be able to join

Patient age is over 18 years
Patient is undergoing Cardiac MRI with sequences that permit biventricular volumetric analysis
Patient is capable of giving informed consent
The cardiac MRI images are of diagnostic quality to provide accurate RV and LV volumes

Who cannot join

Patient unable to under echocardiogram

Trial locations and contacts

1 site in 1 country.

United States1 site

Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756

Other trials in United States

About this study

Official title: A Single-Center, Blinded, Randomized Control Trial Evaluating Different Approaches to Evaluation of Right Ventricular Size and Function Using the Upper Valley Right Ventricle Algorithm and Novel Imaging Modalities

Read the detailed description

This is a single-center, blinded, randomized control trial of patients 18-years or older that are undergoing CMR as a standard of care at Dartmouth-Hitchcock Medical Center in Lebanon, NH. After informed consent is obtained, subjects undergo a study-specific external, non-invasive echocardiogram utilizing a special RV focused protocol on the same day of their CMR as close to their scheduled CMR as possible to minimize wait time for consented patients. The echocardiogram takes approximately an additional 30 minutes of the subject's time.

De-identified echocardiogram images from each subject will be evaluated by experienced echocardiographers using three different methodologies (standard method, Phillips Novel technology and the newly developed UVRV algorithm). The methodologies will be compared with each other to determine sensitivity, specificity and accuracy.

Conditions: Pulmonary Hypertension, Valvular Heart Disease, Congenital Heart Disease, Congestive Heart Failure, Pulmonary Embolism, Acute Coronary Syndrome
Being tested: Measuring Right Ventricular Size and Function
Medical subject headings: Hypertension, Pulmonary, Heart Valve Diseases, Heart Defects, Congenital, Heart Failure, Pulmonary Embolism, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Measuring Right Ventricular Size and FunctionDiagnostic test
This study focuses on evaluating different approaches to evaluation of right ventricular size and function using the Upper Valley Right Ventricle Algorithm and novel imaging modalities

What is being measured

The primary outcome is the main question the study is designed to answer.

Echocardiographic measurement - Right ventricular size
De-identified echocardiogram images from each subject will be evaluated by experienced echocardiographers using three (3) different methodologies. Specific evaluating MRI derived right ventricular volumes versus various echo approaches to grading right ventricular size.
Measured: Echocardiographic measurements are taken on the same day as the scheduled CMR, as close to the scheduled CMR as possible, approximately 1 hour
Echocardiographic measurement - Right ventricular function
De-identified echocardiogram images from each subject will be evaluated by experienced echocardiographers using three (3) different methodologies.
Measured: Echocardiographic measurements are taken on the same day as the scheduled CMR as possible, as close to the scheduled CMR, approximately 1 hour
Echocardiographic measurement - Right ventricular dysfunction severity
De-identified echocardiogram images from each subject will be evaluated by experienced echocardiographers using three (3) different methodologies. Severity reported as mild, moderate or severe)
Measured: Echocardiographic measurements are taken on the same day as the scheduled CMR as possible, as close to the scheduled CMR, approximately 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Aug 201930 Jan 2022

First posted2 May 2019
Study start5 Aug 2019
Primary completion30 Jan 2022
Study completion30 Jan 2022

Why it stopped: funding

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (24)Papers the sponsor has linked to this study.
Other trials for Pulmonary HypertensionStudies 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: Other
Time perspective: Prospective
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03935178
Sponsor's protocol ID: D19082 HVC 2019
Acronym: UVRV
Status last verified: Mar 2022
First submitted: 30 Apr 2019
Last updated: 6 Apr 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual participant echocardiographic data that underlie the results reported in all publications will be shared after deidentification (text, tables, figures and appendices). The informed consent and study plan will also be shared following publication of the study results.

Publications

Graham TP Jr, Bernard YD, Mellen BG, Celermajer D, Baumgartner H, Cetta F, Connolly HM, Davidson WR, Dellborg M, Foster E, Gersony WM, Gessner IH, Hurwitz RA, Kaemmerer H, Kugler JD, Murphy DJ, Noonan JA, Morris C, Perloff JK, Sanders SP, Sutherland JL. Long-term outcome in congenitally corrected transposition of the great arteries: a multi-institutional study. J Am Coll Cardiol. 2000 Jul;36(1):255-61. doi: 10.1016/s0735-1097(00)00682-3.
PubMed 10898443
Chaowalit N, Durongpisitkul K, Krittayaphong R, Komoltri C, Jakrapanichakul D, Phrudprisan S. Echocardiography as a simple initial tool to assess right ventricular dimensions in patients with repaired tetralogy of Fallot before undergoing pulmonary valve replacement: comparison with cardiovascular magnetic resonance imaging. Echocardiography. 2012 Nov;29(10):1239-46. doi: 10.1111/j.1540-8175.2012.01766.x. Epub 2012 Jul 2.
PubMed 22748061
Burgess MI, Mogulkoc N, Bright-Thomas RJ, Bishop P, Egan JJ, Ray SG. Comparison of echocardiographic markers of right ventricular function in determining prognosis in chronic pulmonary disease. J Am Soc Echocardiogr. 2002 Jun;15(6):633-9. doi: 10.1067/mje.2002.118526.
PubMed 12050605
D'Alonzo GE, Barst RJ, Ayres SM, Bergofsky EH, Brundage BH, Detre KM, Fishman AP, Goldring RM, Groves BM, Kernis JT, et al. Survival in patients with primary pulmonary hypertension. Results from a national prospective registry. Ann Intern Med. 1991 Sep 1;115(5):343-9. doi: 10.7326/0003-4819-115-5-343.
PubMed 1863023
de Groote P, Millaire A, Foucher-Hossein C, Nugue O, Marchandise X, Ducloux G, Lablanche JM. Right ventricular ejection fraction is an independent predictor of survival in patients with moderate heart failure. J Am Coll Cardiol. 1998 Oct;32(4):948-54. doi: 10.1016/s0735-1097(98)00337-4.
PubMed 9768716
Dursunoglu N, Dursunoglu D, Yildiz AI, Rota S. Evaluation of cardiac biomarkers and right ventricular dysfunction in patients with acute pulmonary embolism. Anatol J Cardiol. 2016 Apr;16(4):276-82. doi: 10.5152/akd.2014.5828. Epub 2014 Dec 31.
PubMed 26645262
Mehta SR, Eikelboom JW, Natarajan MK, Diaz R, Yi C, Gibbons RJ, Yusuf S. Impact of right ventricular involvement on mortality and morbidity in patients with inferior myocardial infarction. J Am Coll Cardiol. 2001 Jan;37(1):37-43. doi: 10.1016/s0735-1097(00)01089-5.
PubMed 11153770
Zehender M, Kasper W, Kauder E, Geibel A, Schonthaler M, Olschewski M, Just H. Eligibility for and benefit of thrombolytic therapy in inferior myocardial infarction: focus on the prognostic importance of right ventricular infarction. J Am Coll Cardiol. 1994 Aug;24(2):362-9. doi: 10.1016/0735-1097(94)90289-5.
PubMed 8034869
Anavekar NS, Gerson D, Skali H, Kwong RY, Yucel EK, Solomon SD. Two-dimensional assessment of right ventricular function: an echocardiographic-MRI correlative study. Echocardiography. 2007 May;24(5):452-6. doi: 10.1111/j.1540-8175.2007.00424.x.
PubMed 17456062
Bleeker GB, Steendijk P, Holman ER, Yu CM, Breithardt OA, Kaandorp TA, Schalij MJ, van der Wall EE, Nihoyannopoulos P, Bax JJ. Assessing right ventricular function: the role of echocardiography and complementary technologies. Heart. 2006 Apr;92 Suppl 1(Suppl 1):i19-26. doi: 10.1136/hrt.2005.082503. No abstract available.
PubMed 16543597
Helbing WA. Right ventricular function: the comeback of echocardiography? Eur J Echocardiogr. 2004 Mar;5(2):99-101. doi: 10.1016/j.euje.2003.12.001. No abstract available.
PubMed 15036018
Jorstig S, Waldenborg M, Liden M, Thunberg P. Right ventricular ejection fraction measurements using two-dimensional transthoracic echocardiography by applying an ellipsoid model. Cardiovasc Ultrasound. 2017 Mar 7;15(1):4. doi: 10.1186/s12947-017-0096-5.
PubMed 28270161
Zornoff LA, Skali H, Pfeffer MA, St John Sutton M, Rouleau JL, Lamas GA, Plappert T, Rouleau JR, Moye LA, Lewis SJ, Braunwald E, Solomon SD; SAVE Investigators. Right ventricular dysfunction and risk of heart failure and mortality after myocardial infarction. J Am Coll Cardiol. 2002 May 1;39(9):1450-5. doi: 10.1016/s0735-1097(02)01804-1.
PubMed 11985906
Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.
PubMed 20620859
Kjaergaard J, Petersen CL, Kjaer A, Schaadt BK, Oh JK, Hassager C. Evaluation of right ventricular volume and function by 2D and 3D echocardiography compared to MRI. Eur J Echocardiogr. 2006 Dec;7(6):430-8. doi: 10.1016/j.euje.2005.10.009. Epub 2005 Dec 9.
PubMed 16338173

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Center, Blinded, Randomized Control Trial Evaluating Different Approaches to Evaluation of Right Ventricular Size and Function Using the Upper Valley Right Ventricle Algorithm and Novel Imaging Modalities
ClinicalTrials.gov ID: NCT03935178
Acronym / sponsor ID: UVRV / D19082 HVC 2019
Conditions: Pulmonary Hypertension, Valvular Heart Disease, Congenital Heart Disease, Congestive Heart Failure, Pulmonary Embolism, Acute Coronary Syndrome
Study type: Observational
Recruitment status: TerminatedReason stopped: funding
Enrolment: 14 participants (actual)
Lead sponsor: Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
Study start: 5 Aug 2019 (actual)
Primary completion: 30 Jan 2022 (actual)
Study completion: 30 Jan 2022 (actual)
First posted: 2 May 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.

Detailed description

Study design

Observational model: Other
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: This study is for people who are18-years or older that are undergoing cardiac magnetic resonance imaging (CMR) as a standard of care at Dartmouth-Hitchcock Medical Center in Lebanon, NH.

Key inclusion criteria (4 listed)

Patient age is over 18 years
Patient is undergoing Cardiac MRI with sequences that permit biventricular volumetric analysis
Patient is capable of giving informed consent
The cardiac MRI images are of diagnostic quality to provide accurate RV and LV volumes

Key exclusion criteria (1 listed)

Patient unable to under echocardiogram

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
Measuring Right Ventricular Size and FunctionThis study focuses on evaluating different approaches to evaluation of right ventricular size and function using the Upper Valley Right Ventricle Algorithm and novel imaging modalities	Diagnostic test	–

Primary outcome

Echocardiographic measurement - Right ventricular size
Time frame: Echocardiographic measurements are taken on the same day as the scheduled CMR, as close to the scheduled CMR as possible, approximately 1 hour
De-identified echocardiogram images from each subject will be evaluated by experienced echocardiographers using three (3) different methodologies. Specific evaluating MRI derived right ventricular volumes versus various echo approaches to grading right ventricular size.
Echocardiographic measurement - Right ventricular function
Time frame: Echocardiographic measurements are taken on the same day as the scheduled CMR as possible, as close to the scheduled CMR, approximately 1 hour
De-identified echocardiogram images from each subject will be evaluated by experienced echocardiographers using three (3) different methodologies.
Echocardiographic measurement - Right ventricular dysfunction severity
Time frame: Echocardiographic measurements are taken on the same day as the scheduled CMR as possible, as close to the scheduled CMR, approximately 1 hour
De-identified echocardiogram images from each subject will be evaluated by experienced echocardiographers using three (3) different methodologies. Severity reported as mild, moderate or severe)

Results and safety

The study was stopped early (reason given: funding). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
Background: PubMed 10898443Graham TP Jr, Bernard YD, Mellen BG, Celermajer D, Baumgartner H, Cetta F, Connolly HM, Davidson WR, Dellborg M, Foster E, Gersony WM, Gessner IH, Hurwitz RA, Kaemmerer H, Kugler JD, Murphy DJ, Noonan JA, Morris C, Perloff JK, Sanders SP, Sutherland JL. Long-term outcome in congenitally corrected transposition of the great arteries: a multi-institutional study. J Am Coll Cardiol. 2000 Jul;36(1):255-61. doi: 10.1016/s0735-1097(00)00682-3.
Background: PubMed 22748061Chaowalit N, Durongpisitkul K, Krittayaphong R, Komoltri C, Jakrapanichakul D, Phrudprisan S. Echocardiography as a simple initial tool to assess right ventricular dimensions in patients with repaired tetralogy of Fallot before undergoing pulmonary valve replacement: comparison with cardiovascular magnetic resonance imaging. Echocardiography. 2012 Nov;29(10):1239-46. doi: 10.1111/j.1540-8175.2012.01766.x. Epub 2012 Jul 2.
Background: PubMed 12050605Burgess MI, Mogulkoc N, Bright-Thomas RJ, Bishop P, Egan JJ, Ray SG. Comparison of echocardiographic markers of right ventricular function in determining prognosis in chronic pulmonary disease. J Am Soc Echocardiogr. 2002 Jun;15(6):633-9. doi: 10.1067/mje.2002.118526.
Background: PubMed 1863023D'Alonzo GE, Barst RJ, Ayres SM, Bergofsky EH, Brundage BH, Detre KM, Fishman AP, Goldring RM, Groves BM, Kernis JT, et al. Survival in patients with primary pulmonary hypertension. Results from a national prospective registry. Ann Intern Med. 1991 Sep 1;115(5):343-9. doi: 10.7326/0003-4819-115-5-343.
Background: PubMed 9768716de Groote P, Millaire A, Foucher-Hossein C, Nugue O, Marchandise X, Ducloux G, Lablanche JM. Right ventricular ejection fraction is an independent predictor of survival in patients with moderate heart failure. J Am Coll Cardiol. 1998 Oct;32(4):948-54. doi: 10.1016/s0735-1097(98)00337-4.
Background: PubMed 26645262Dursunoglu N, Dursunoglu D, Yildiz AI, Rota S. Evaluation of cardiac biomarkers and right ventricular dysfunction in patients with acute pulmonary embolism. Anatol J Cardiol. 2016 Apr;16(4):276-82. doi: 10.5152/akd.2014.5828. Epub 2014 Dec 31.
Background: PubMed 11153770Mehta SR, Eikelboom JW, Natarajan MK, Diaz R, Yi C, Gibbons RJ, Yusuf S. Impact of right ventricular involvement on mortality and morbidity in patients with inferior myocardial infarction. J Am Coll Cardiol. 2001 Jan;37(1):37-43. doi: 10.1016/s0735-1097(00)01089-5.
Background: PubMed 8034869Zehender M, Kasper W, Kauder E, Geibel A, Schonthaler M, Olschewski M, Just H. Eligibility for and benefit of thrombolytic therapy in inferior myocardial infarction: focus on the prognostic importance of right ventricular infarction. J Am Coll Cardiol. 1994 Aug;24(2):362-9. doi: 10.1016/0735-1097(94)90289-5.
Background: PubMed 17456062Anavekar NS, Gerson D, Skali H, Kwong RY, Yucel EK, Solomon SD. Two-dimensional assessment of right ventricular function: an echocardiographic-MRI correlative study. Echocardiography. 2007 May;24(5):452-6. doi: 10.1111/j.1540-8175.2007.00424.x.
Background: PubMed 16543597Bleeker GB, Steendijk P, Holman ER, Yu CM, Breithardt OA, Kaandorp TA, Schalij MJ, van der Wall EE, Nihoyannopoulos P, Bax JJ. Assessing right ventricular function: the role of echocardiography and complementary technologies. Heart. 2006 Apr;92 Suppl 1(Suppl 1):i19-26. doi: 10.1136/hrt.2005.082503. No abstract available.
Background: PubMed 15036018Helbing WA. Right ventricular function: the comeback of echocardiography? Eur J Echocardiogr. 2004 Mar;5(2):99-101. doi: 10.1016/j.euje.2003.12.001. No abstract available.
Background: PubMed 28270161Jorstig S, Waldenborg M, Liden M, Thunberg P. Right ventricular ejection fraction measurements using two-dimensional transthoracic echocardiography by applying an ellipsoid model. Cardiovasc Ultrasound. 2017 Mar 7;15(1):4. doi: 10.1186/s12947-017-0096-5.
Individual participant dataSharing planned: Yes. Individual participant echocardiographic data that underlie the results reported in all publications will be shared after deidentification (text, tables, figures and appendices). The informed consent and study plan will also be shared following publication of the study results.

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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.

Scott Friedman, MD principal investigator

Dartmouth-Hitchcock Medical Center

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 Pulmonary Hypertension and Valvular Heart Disease, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 6 Apr 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 United States. 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 stopped early (reason given: funding). Results are not available in the source record.

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?

Echocardiographic measurement - Right ventricular size (time frame: Echocardiographic measurements are taken on the same day as the scheduled CMR, as close to the scheduled CMR as possible, approximately 1 hour). The study lists 3 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 NCT03935178, which also lists 24 linked publications.

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 6 Apr 2022.