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Chronic Heart FailureRIVED-CHFNCT06002321

Right Ventricular Dysfunction in Chronic Heart Failure

An observational study of Chronic Heart Failure and Right Ventricular Dysfunction, run by University of Siena at 14 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this multi center observational prospective study is to analyze the concordance between the signs and symptoms of RHF and echocardiographic features of RVD in patient with heart failure. The main questions it aims to answer are: 1. to assess the incidence of RVH and RVD in each HF subtypes. 2. Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
Echocardiography and Laboratory Test
How many people
1,000 participants
Where
14 sitesItaly
Study dates
1 Sep 2023to 1 Sep 2026
How long will I take part?
36 Months
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients with chronic heart failure will be consecutively enrolled prospectively in different cities. The diagnosis will be made on the basis of the signs and symptoms of the disease associated with BNP and NT-proBNP levels. Patients will be classified according to the type of cardiac structure and remodeling defect and ejection fraction.

Who may be able to join

  • All patients with a diagnosis of chronic heart failure made according to the recommendations of the ESC guidelines through the simultaneous presence of signs and symptoms of disease associated with BNP and NT proBNP levels > 100 and 300 pg/ml respectively which are associated with a modest increase PAPS > 30 mmHg with or without right ventricular dilatation.

Who cannot join

  • Patients with dyspnea of non-cardiogenic origin, related to systemic respiratory diseases, pulmonary embolism, patients with primary pulmonary hypertension will be excluded.
  • Patients with heart failure linked to primary valvular pathologies or infiltrative pathologies, secondary and on a genetic basis, patients diagnosed with acute heart failure in non-optimized therapy for at least 3 months will also be excluded. - Patients with systemic inflammatory neoplastic diseases, advanced liver and kidney diseases awaiting transplantation will be excluded.

Trial locations and contacts

14 sites in 1 country.

Alberto Palazzuoli, MD contact

+390577585363

palazzuoli2@unisi.it

14 sites in 1 country

Italy14 sites

  • Department of Medicine, Surgery and Dentistry, Università di Salerno

    Fisciano, Salerno, 84084

    Michele Ciccarelli, MD, mciccarelli@unisa.it

    Michele Ciccarelli, MD

  • SC Universitaria di Cardiologia - UTIC Policlinico Riuniti Foggia

    Foggia, 71121

    Michele Correale, MD, michele.correale@libero.it

    Michele Correale, MD

  • Department of Clinical and Experimental Medicine, Operativee Unit of Cardiology, University of Messina

    Messina, 98125

    Giuseppe Dattilo, MD, dattimed@hotmail.it

    Giuseppe Dattilo, MD

  • Centro Cardiologico Monzino

    Milan, Milano, 20138

    Pier Giuseppe Agostoni, MD, piergiuseppe.agostoni@unimi.it

    Pier Giuseppe Agostoni, MD

  • Ospedale Sant'Agostino Milano

    Milan, 20127

    Frank Dini, MD, franklloyddini@gmail.com

    Frank Dini, MD

  • Department of Translational Medical Sciences, CIRCET

    Naples, 80131

    Gabriele Tocchetti, MD

    Gabriele Tocchetti, MD

  • Department of Translational Medical Sciences, Federico II University, CIRCET

    Naples, 80131

    Valentina Mercurio, MD

    Valentina Mercurio, MD

  • Heart Failure Unit, Department of Cardiology, AORN dei Colli-Monaldi

    Naples, 80131

    Daniele Masarone, MD, danielemasarone@gmail.com

    Daniele Masarone, MD

  • Fondazione IRCCS Policlinico San Matteo - Pavia UOC Cardiologia 1

    Pavia, 27100

    Stefano Ghio, MD, s.ghio@smatteo.pv.it

    Stefano Ghio, MD

  • S. Maria della Misericordia Hospital

    Perugia, 06100

    Erberto Carluccio, MD, erberto.carluccio@unipg.it

    Erberto Carluccio, MD

  • SC Cardiologia, Azienda Ospedaliera Ospedale San Carlo Potenza

    Potenza, 85100

    Pietro Mazzeo, MD, pietromazzeo91@tiscali.it

    Pietro Mazzeo, MD

  • Cardiology, Department of Clinica, Internal, Anesthesiology and Cardiovascular Scienses, Sapienza.

    Roma, 00161

    Paolo Severino, MD, paolo.severino@uniroma1.it

    Paolo Severino, MD

  • Cardiology, Department of Clinica, Internal, Anesthesiology and Cardiovascular Scienses.

    Roma, 00161

    Roberto Badagliaca, MD, roberto.badagliacca@uniroma1.it

    Roberto Badagliacca, MD

  • Unità di Malattie Cardiovascolari, Dipartimento Cardio-Toraco-Vascolare AOUS, Università degli Studi, Siena.

    Siena, 53100

    Alberto Palazzuoli, MD, palazzuoli2@unisi.it

    Alberto Palazzuoli, MD

Other trials in Italy

About this study

Official title: Right Ventricular Dysfunction in Chronic Heart Failure: Clinical Laboratory and Echocardiographic Characteristics

The goal of this multi center observational prospective study is to analyze the concordance between the signs and symptoms of RHF and echocardiographic features of RVD in patient with heart failure. The main questions it aims to answer are:

  1. to assess the incidence of RVH and RVD in each HF subtypes.
  2. to evaluate prognostic impact ( in terms of cardiovascular mortality and HF hospitalization) of different RVD patterns during a mean followup period of 3 years
  3. To investigate the incidence of different RV maladaptation ( isolated RV dilatation, isolated Pulmonary hypertension, combined pattern) in each HF groups and the related outcome.

Participants will follow by direct check up visit and/or virtual visits every 6 months for a mean follow-up period of 3 years.

Read the detailed description

Right ventricular dysfunction (RVD) and pulmonary hypertension (PH) have been recognized as two important prognostic features in patients with left side heart failure (HF). Nevertheless literature does not distinguish between right heart failure (RHF) and RVD, and the two terms are indifferently employed to describe PH and impaired RV performance. This is a multicenter observational prospective study endorsed by the Italian Society of Cardiology that would analyse the concordance between the signs and symptoms of RHF and echocardiographic features of RVD. Therefore the right ventricle (RV) adaptation across different left ventricular ejection fraction (LVEF) values, is poorly investigated. According to the recent heart failure (HF) guidelines classified patients based on LVEF in HF with preserved ( HFpEF) mild reduced (HFmEF) and reduced LVEF ( HFrEF), the investigators would assess by seral clinical laboratory and detailed echocardiographic study all patients affected by chronic HF regardless LVEF threshold in stable condition and will follow by direct check up visit and/or virtual visits every 6 months for a mean follow-up period of 3 years. All clinical laboratory and echocardiographic data will be recorded in a web platform system accessible for all center included in the study The main aims of the study are; 1- to assess the incidence of RVH and RVD in each HF subtypes. 2- to evaluate prognostic impact ( in terms of cardiovascular mortality and HF hospitalization) of different RVD patterns during a mean followup period of 3 years 3- To investigate the incidence of different RV maladaptation ( isolated RV dilatation, isolated Pulmonary hypertension, combined pattern) in each HF groups and the related outcome. The investigators expect to find different RVD degree and severity according to the type of left HF and its severity. Additionally, by a serial multiparametric analysis of RV, it would be possible to establish the stage and type of RVD and consequent concordance with signs of RHF.

Being tested
Echocardiography, Laboratory Test
Medical subject headings
Ventricular Dysfunction, Right, Heart Failure

What participants receive

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

  • EchocardiographyDiagnostic test

    Patients will undergo echocardiographic examination. The ejection fraction will be calculated using Simpson's method. The E/e' ratio will be measured using the Doppler method. E/e' > 13 will be considered an expression of the increase in LVFP. TAPSE will be measured together with the peak tricuspid regurgitation velocity (TVR). Pulmonary arterial hypertension will be defined as TVR > 2.8 m/s. Estimation of right atrial pressure (eRAP) will be obtained based on the diameter and inspiratory collapsibility of the inferior vena cava.

  • Laboratory TestDiagnostic test

    BNP, NT-proBNP and renal function.

Study groups in NCT06002321
Study groupRoleWhat they receive
HFpEFThe HFpEF group includes patients with signs and/or symptoms of heart failure and LVEF > 50% and objective evidence of structural and/or functional cardiac abnormalities consistent with the presence of LV diastolic dysfunction/raised LV filling pressures, including raised natriuretic peptides.
Receives: Diagnostic Test: Echocardiography; Diagnostic Test: Laboratory Test
HFmrEFThe HFmrEF group includes patients with signs and/or symptoms of heart failure and LVEF 41-49%.
Receives: Diagnostic Test: Echocardiography; Diagnostic Test: Laboratory Test
HFrEFThe HFrEF group includes patients with signs and/or symptoms of heart failure and LVEF < 40%.
Receives: Diagnostic Test: Echocardiography; Diagnostic Test: Laboratory Test

What is being measured

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

  1. Different patterns of RVD in chronic heart failure.

    The different patterns of RVD will be evaluated with echocardiographic measurements. Right ventricular function will be assessed by the following echocardiographic parameters: tricuspid annular plane excursion (TAPSE) and right ventricular fractional area change (RVFAC).

    Measured: 6 months.

  2. Analyze the incidence and prevalence of RVD and RHF.

    To analyze the incidence and prevalence of RVD and RHF according to left ventricular ejection fraction (HFrEF, HFmrEF, HFpEF).

    Measured: 6 months.

  3. Compare the clinical signs of right heart failure with the echocardiographic signs of RVD.

    Compare clinical signs of right heart failure with echocardiographic parameters of right ventricular dysfunction in order to verify agreement and identify a precise relationship between RHF and RVD.

    Measured: 6 months.

Secondary outcomes (2)

  1. Define the incidence of RVD.

    To define the incidence of RVD through a multiparametric echocardiographic analysis including all the echocardiographic parameters of right ventricular function in order to identify a precise score based on the simultaneous dysfunction of several parameters.

    Measured: 6 months.

  2. Investigate a correlation between the different parameters.

    Investigate a correlation between echo parameters, clinical signs and laboratory data.

    Measured: 6 months.

Timeline

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

  1. First posted21 Aug 2023
  2. Study start1 Sep 2023 (estimated)
  3. Primary completion1 Mar 2024 (estimated)
  4. Study completion1 Sep 2026 (estimated)

Resources

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
1,000 participants (estimated)
Target duration
36 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06002321
Sponsor's protocol ID
RIVED - CHF
Acronym
RIVED-CHF
Status last verified
Aug 2023
First submitted
21 Jul 2023
Last updated
21 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Furey SA 3rd, Zieske HA, Levy MN. The essential function of the right ventricle. Am Heart J. 1984 Feb;107(2):404-10. doi: 10.1016/0002-8703(84)90402-2. No abstract available.

    PubMed 6695680

  • Poels EM, da Costa Martins PA, van Empel VP. Adaptive capacity of the right ventricle: why does it fail? Am J Physiol Heart Circ Physiol. 2015 Apr 15;308(8):H803-13. doi: 10.1152/ajpheart.00573.2014. Epub 2015 Feb 13.

    PubMed 25681425

  • Haddad F, Doyle R, Murphy DJ, Hunt SA. Right ventricular function in cardiovascular disease, part II: pathophysiology, clinical importance, and management of right ventricular failure. Circulation. 2008 Apr 1;117(13):1717-31. doi: 10.1161/CIRCULATIONAHA.107.653584. No abstract available.

    PubMed 18378625

  • Meyer P, Filippatos GS, Ahmed MI, Iskandrian AE, Bittner V, Perry GJ, White M, Aban IB, Mujib M, Dell'Italia LJ, Ahmed A. Effects of right ventricular ejection fraction on outcomes in chronic systolic heart failure. Circulation. 2010 Jan 19;121(2):252-8. doi: 10.1161/CIRCULATIONAHA.109.887570. Epub 2010 Jan 4.

    PubMed 20048206

  • Voelkel NF, Gomez-Arroyo J, Abbate A, Bogaard HJ. Mechanisms of right heart failure-A work in progress and a plea for failure prevention. Pulm Circ. 2013 Jan;3(1):137-43. doi: 10.4103/2045-8932.109957. No abstract available.

    PubMed 23662190

  • Markel TA, Wairiuko GM, Lahm T, Crisostomo PR, Wang M, Herring CM, Meldrum DR. The right heart and its distinct mechanisms of development, function, and failure. J Surg Res. 2008 May 15;146(2):304-13. doi: 10.1016/j.jss.2007.04.003. Epub 2007 Nov 26.

    PubMed 18036544

  • Ghio S, Acquaro M, Agostoni P, Ambrosio G, Carluccio E, Castiglione V, Colombo D, D'Alto M, Delle Grottaglie S, Dini FL, Emdin M, Fortunato M, Guaricci AI, Jacoangeli F, Marra AM, Paolillo S, Papa S, Scajola LV, Correale M, Palazzuoli A. Right heart failure in left heart disease: imaging, functional, and biochemical aspects of right ventricular dysfunction. Heart Fail Rev. 2023 Jul;28(4):1009-1022. doi: 10.1007/s10741-022-10276-0. Epub 2022 Nov 16.

    PubMed 36385328

  • 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

  • Gorter TM, van Veldhuisen DJ, Bauersachs J, Borlaug BA, Celutkiene J, Coats AJS, Crespo-Leiro MG, Guazzi M, Harjola VP, Heymans S, Hill L, Lainscak M, Lam CSP, Lund LH, Lyon AR, Mebazaa A, Mueller C, Paulus WJ, Pieske B, Piepoli MF, Ruschitzka F, Rutten FH, Seferovic PM, Solomon SD, Shah SJ, Triposkiadis F, Wachter R, Tschope C, de Boer RA. Right heart dysfunction and failure in heart failure with preserved ejection fraction: mechanisms and management. Position statement on behalf of the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2018 Jan;20(1):16-37. doi: 10.1002/ejhf.1029. Epub 2017 Oct 16.

    PubMed 29044932

  • Nagueh SF, Bhatt R, Vivo RP, Krim SR, Sarvari SI, Russell K, Edvardsen T, Smiseth OA, Estep JD. Echocardiographic evaluation of hemodynamics in patients with decompensated systolic heart failure. Circ Cardiovasc Imaging. 2011 May;4(3):220-7. doi: 10.1161/CIRCIMAGING.111.963496. Epub 2011 Mar 11.

    PubMed 21398512

  • Sanz J, Sanchez-Quintana D, Bossone E, Bogaard HJ, Naeije R. Anatomy, Function, and Dysfunction of the Right Ventricle: JACC State-of-the-Art Review. J Am Coll Cardiol. 2019 Apr 2;73(12):1463-1482. doi: 10.1016/j.jacc.2018.12.076.

    PubMed 30922478

  • Drazner MH, Hamilton MA, Fonarow G, Creaser J, Flavell C, Stevenson LW. Relationship between right and left-sided filling pressures in 1000 patients with advanced heart failure. J Heart Lung Transplant. 1999 Nov;18(11):1126-32. doi: 10.1016/s1053-2498(99)00070-4.

    PubMed 10598737

  • Melenovsky V, Hwang SJ, Lin G, Redfield MM, Borlaug BA. Right heart dysfunction in heart failure with preserved ejection fraction. Eur Heart J. 2014 Dec 21;35(48):3452-62. doi: 10.1093/eurheartj/ehu193. Epub 2014 May 29.

    PubMed 24875795

  • Bosch L, Lam CSP, Gong L, Chan SP, Sim D, Yeo D, Jaufeerally F, Leong KTG, Ong HY, Ng TP, Richards AM, Arslan F, Ling LH. Right ventricular dysfunction in left-sided heart failure with preserved versus reduced ejection fraction. Eur J Heart Fail. 2017 Dec;19(12):1664-1671. doi: 10.1002/ejhf.873. Epub 2017 Jun 8.

    PubMed 28597497

  • Gorter TM, Hoendermis ES, van Veldhuisen DJ, Voors AA, Lam CS, Geelhoed B, Willems TP, van Melle JP. Right ventricular dysfunction in heart failure with preserved ejection fraction: a systematic review and meta-analysis. Eur J Heart Fail. 2016 Dec;18(12):1472-1487. doi: 10.1002/ejhf.630. Epub 2016 Sep 20.

    PubMed 27650220

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Heart Failure and Right Ventricular Dysfunction, run by University of Siena at 14 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 1 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: status not confirmed, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alberto Palazzuoli, MD (+390577585363, palazzuoli2@unisi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Different patterns of RVD in chronic heart failure. (time frame: 6 months.). 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 NCT06002321, which also lists 33 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 21 Aug 2023.

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