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The overarching goal of this research proposal is to study the feasibility and clinical impact of implementing an Inova system-wide heart failure treatment algorithm for patients with symptomatic heart failure due to reduced left ventricular ejection fraction (HFreF) and secondary MR
Aim is to check the effectiveness of the IHFTA in identifying patients who are most likely to benefit from percutaneous transcatheter Mitraclip repair in real world
All patients passing through the IHFTA will be tracked and followed w.r.t. their final therapies. Monthly meetings will occur with the IHFTA research team to assess and discuss any challenges in implementing the protocol. Impediments will be identified, and strategies put forth to address them. To examine whether the Inova IHFTA identifies the patient most likely to benefit from Mitraclip, the baseline clinical and echocardiographic characteristics of patients treated with Mitraclip within the IHFTA (who would have met the criteria for COAPT study) will be compared to those of the treated cohort in the COAPT trial using t-tests and Chi-squared tests
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate MR | Patients who present with moderate MR and remain in this state will be re-evaluated at 6 months by a phone call and EMR review for ConComitant Cardiac Medication Review, NYHA Class and Adverse Event Evaluation. At 12 months a follow-up evaluation that will include a review of medications, NYHA class, KCCQ, 6MWT, BNP, Adverse Event review and TTE. |
| |
| Mitraclip | For patient who undergo Mitraclip, the safety and effectiveness of the procedure will be evaluated and all peri-procedural complications recorded using the same definitions for procedural success and complications used in the COAPT trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MitraClip | Device | Participants will undergo the Mitraclip procedure according to current standards of practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in NYHA from baseline to 6 months in patients who undergo Mitraclip | There are 4 levels of NYHA: I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea. II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea. III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased. Improvement is defined as moving from a higher numerical NYHA level to a lower numerical NYHA level (e.g., IV to III). | baseline to 6 months post Mitraclip procedure |
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Inclusion Criteria:
Exclusion Criteria:
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The study population for this study include adult patients > 18 years of age who have symptomatic (NYHA class II-IVa) HFreF due to ischemic or idiopathic dilated cardiomyopathy (LV ejection fraction ≤ 50%), moderate (2+) to severe (4+) secondary MR and either at least 1 HF hospitalization within the prior 12 months or an elevated brain natriuretic peptide (BNP≥300) or N-terminal pro b-type natriuretic peptide (NT-proBNP ≥ 1500) and have been determined by the site's local heart team as not being appropriate for MV surgery. This study population is similar to patients enrolled in COAPT, but includes patients who present with moderate 2+ MR and others who may end up needing only optimal GDMT and/or CRT or Cardiomems.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hassan Saeed | Contact | (703) 776-5716 | hassan.saeed@inova.org | |
| Mahira Awan | Contact | (703) 776-5716 | mahira.awan@inova.org |
| Name | Affiliation | Role |
|---|---|---|
| Matthew Sherwood, MD | Inova Health Care Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inova Fairfax Medical Campus | Recruiting | Falls Church | Virginia | 22042 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16980116 | Background | Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006 Sep 16;368(9540):1005-11. doi: 10.1016/S0140-6736(06)69208-8. | |
| 21807656 | Background | Rossi A, Dini FL, Faggiano P, Agricola E, Cicoira M, Frattini S, Simioniuc A, Gullace M, Ghio S, Enriquez-Sarano M, Temporelli PL. Independent prognostic value of functional mitral regurgitation in patients with heart failure. A quantitative analysis of 1256 patients with ischaemic and non-ischaemic dilated cardiomyopathy. Heart. 2011 Oct;97(20):1675-80. doi: 10.1136/hrt.2011.225789. Epub 2011 Jul 31. |
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| Moderate MR | Other | Patients who present with moderate MR (Mitral regurgitation) will serve also as an internal control against which the outcomes of Mitraclip treated patients) |
|
| 4908819 | Background | Hayashi S, Fushimi H. [Shock and lymphatic circulation]. Nihon Rinsho. 1970 Jan;28(1):84-9. No abstract available. Japanese. |
| 30280640 | Background | Stone GW, Lindenfeld J, Abraham WT, Kar S, Lim DS, Mishell JM, Whisenant B, Grayburn PA, Rinaldi M, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Marx SO, Cohen DJ, Weissman NJ, Mack MJ; COAPT Investigators. Transcatheter Mitral-Valve Repair in Patients with Heart Failure. N Engl J Med. 2018 Dec 13;379(24):2307-2318. doi: 10.1056/NEJMoa1806640. Epub 2018 Sep 23. |
| 30145927 | Background | Obadia JF, Messika-Zeitoun D, Leurent G, Iung B, Bonnet G, Piriou N, Lefevre T, Piot C, Rouleau F, Carrie D, Nejjari M, Ohlmann P, Leclercq F, Saint Etienne C, Teiger E, Leroux L, Karam N, Michel N, Gilard M, Donal E, Trochu JN, Cormier B, Armoiry X, Boutitie F, Maucort-Boulch D, Barnel C, Samson G, Guerin P, Vahanian A, Mewton N; MITRA-FR Investigators. Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation. N Engl J Med. 2018 Dec 13;379(24):2297-2306. doi: 10.1056/NEJMoa1805374. Epub 2018 Aug 27. |
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| 26673558 | Background | Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. No abstract available. |
| 11894224 | Background | Sahyoun NR, Lentzner H, Hoyert D, Robinson KN. Trends in causes of death among the elderly. Aging Trends. 2001 Mar;(1):1-10. doi: 10.1037/e620692007-001. No abstract available. |
| 23747642 | Background | Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Oct 15;62(16):e147-239. doi: 10.1016/j.jacc.2013.05.019. Epub 2013 Jun 5. No abstract available. |
| 4292097 | Background | Larson SL. Trophoblastic disease. Minn Med. 1967 Jan;50(1):81-6. No abstract available. |
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| 25176015 | Background | McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR; PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014 Sep 11;371(11):993-1004. doi: 10.1056/NEJMoa1409077. Epub 2014 Aug 30. |
| 30134187 | Background | Mack MJ, Abraham WT, Lindenfeld J, Bolling SF, Feldman TE, Grayburn PA, Kapadia SR, McCarthy PM, Lim DS, Udelson JE, Zile MR, Gammie JS, Gillinov AM, Glower DD, Heimansohn DA, Suri RM, Ellis JT, Shu Y, Kar S, Weissman NJ, Stone GW. Cardiovascular Outcomes Assessment of the MitraClip in Patients with Heart Failure and Secondary Mitral Regurgitation: Design and rationale of the COAPT trial. Am Heart J. 2018 Nov;205:1-11. doi: 10.1016/j.ahj.2018.07.021. Epub 2018 Aug 1. |
| 10758967 | Background | Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000 Apr;35(5):1245-55. doi: 10.1016/s0735-1097(00)00531-3. |
| 4885562 | Background | Callaghan P, Brodie J. Laboratory investigation of sewer swabs following the Aberdeen typhoid outbreak of 1964. J Hyg (Lond). 1968 Dec;66(4):489-97. doi: 10.1017/s0022172400028230. No abstract available. |
| 26046839 | Background | Zotter-Tufaro C, Mascherbauer J, Duca F, Koell B, Aschauer S, Kammerlander AA, Panzenboeck A, Sadushi-Kolici R, Bangert C, Laimer D, Ristl R, Lang IM, Bonderman D. Prognostic Significance and Determinants of the 6-Min Walk Test in Patients With Heart Failure and Preserved Ejection Fraction. JACC Heart Fail. 2015 Jun;3(6):459-466. doi: 10.1016/j.jchf.2015.01.010. |
| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D006349 | Heart Valve Diseases |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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