Randomised trial of ramipril in repaired tetralogy of Fallot and pulmonary regurgitation The APPROPRIATE study (Ace inhibitors for Potential PRevention Of the deleterious effects of Pulmonary Regurgitation In Adults with repaired TEtralogy of Fallot)
Optimal treatment for stable repaired tetralogy of Fallot (rTOF) patients with pulmonary regurgitation (PR) and related right ventricular (RV) dilatation, including timing of valve implantation, remains uncertain. We sought to study tolerability of the angiotensin-converting-enzyme (ACE) inhibitor r...
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| Veröffentlicht in: | International journal of cardiology 2012-02, Vol.154 (3), p.299-305 |
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| creator | BABU-NARAYAN, Sonya V UEBING, Anselm KILNER, Philip J WEI LI GATZOULIS, Michael A DAVLOUROS, Periklis A KEMP, Michael DAVIDSON, Simon DIMOPOULOS, Konstantinos BAYNE, Stephanie PENNELL, Dudley J GIBSON, Derek G FLATHER, Marcus |
| description | Optimal treatment for stable repaired tetralogy of Fallot (rTOF) patients with pulmonary regurgitation (PR) and related right ventricular (RV) dilatation, including timing of valve implantation, remains uncertain. We sought to study tolerability of the angiotensin-converting-enzyme (ACE) inhibitor ramipril and its effects on cardiovascular function in these patients.
Clinically stable rTOF patients with moderate/severe PR were included. A double-blinded, placebo-controlled study of 6 months of ramipril vs placebo was performed. All patients underwent cardiovascular magnetic resonance (CMR), echocardiography, neurohormonal analysis, and objective cardiopulmonary exercise testing at baseline and follow-up.
The main aim was to detect changes in RV function (primary endpoint CMR-derived RV ejection fraction).
Seventy-two patients were enrolled and 64 qualified for the final analysis. There was no difference in the primary endpoint RV ejection fraction. RV long-axis shortening significantly improved in the ramipril group compared to placebo (RV: 2.3 ± 3.8 vs 0.02 ± 2.7 mm; P=0.017) as did LV long-axis shortening (1.9 ± 4.5 vs -0.2 ± 3.7 mm respectively; P=0.030). No clear differences were detected between ramipril and placebo for other measures. In a subgroup of patients with restrictive RV physiology, ramipril resulted in decrease in LV end-systolic volume index and increase in LVEF (-2.4 ± 5.0 vs 2.7 ± 3.6 mL/m(2); P=0.005, 2.5 ± 5.0 vs -1.3 ± 3.5%; P=0.03). Ramipril did not cause adverse events and was well tolerated.
Ramipril is a well tolerated therapy, improves biventricular function in patients with rTOF and may have a particular role in patients with restrictive RV physiology. Larger, longer-term studies are needed to determine if ACE inhibitors can improve both ventricular remodelling and clinical outcomes. (
97515585). |
| doi_str_mv | 10.1016/j.ijcard.2010.09.057 |
| format | Article |
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Clinically stable rTOF patients with moderate/severe PR were included. A double-blinded, placebo-controlled study of 6 months of ramipril vs placebo was performed. All patients underwent cardiovascular magnetic resonance (CMR), echocardiography, neurohormonal analysis, and objective cardiopulmonary exercise testing at baseline and follow-up.
The main aim was to detect changes in RV function (primary endpoint CMR-derived RV ejection fraction).
Seventy-two patients were enrolled and 64 qualified for the final analysis. There was no difference in the primary endpoint RV ejection fraction. RV long-axis shortening significantly improved in the ramipril group compared to placebo (RV: 2.3 ± 3.8 vs 0.02 ± 2.7 mm; P=0.017) as did LV long-axis shortening (1.9 ± 4.5 vs -0.2 ± 3.7 mm respectively; P=0.030). No clear differences were detected between ramipril and placebo for other measures. In a subgroup of patients with restrictive RV physiology, ramipril resulted in decrease in LV end-systolic volume index and increase in LVEF (-2.4 ± 5.0 vs 2.7 ± 3.6 mL/m(2); P=0.005, 2.5 ± 5.0 vs -1.3 ± 3.5%; P=0.03). Ramipril did not cause adverse events and was well tolerated.
Ramipril is a well tolerated therapy, improves biventricular function in patients with rTOF and may have a particular role in patients with restrictive RV physiology. Larger, longer-term studies are needed to determine if ACE inhibitors can improve both ventricular remodelling and clinical outcomes. (
97515585).</description><identifier>ISSN: 0167-5273</identifier><identifier>EISSN: 1874-1754</identifier><identifier>DOI: 10.1016/j.ijcard.2010.09.057</identifier><identifier>PMID: 20970202</identifier><identifier>CODEN: IJCDD5</identifier><language>eng</language><publisher>Shannon: Elsevier</publisher><subject>Angiotensin-Converting Enzyme Inhibitors - therapeutic use ; Biological and medical sciences ; Cardiology. Vascular system ; Congenital heart diseases. Malformations of the aorta, pulmonary vessels and vena cava ; Double-Blind Method ; Endocardial and cardiac valvular diseases ; Feasibility Studies ; Heart ; Humans ; Medical sciences ; Prospective Studies ; Pulmonary Valve Insufficiency - complications ; Pulmonary Valve Insufficiency - physiopathology ; Ramipril - therapeutic use ; Tetralogy of Fallot - complications ; Tetralogy of Fallot - physiopathology ; Tetralogy of Fallot - surgery ; Time Factors ; Ventricular Function - drug effects</subject><ispartof>International journal of cardiology, 2012-02, Vol.154 (3), p.299-305</ispartof><rights>2015 INIST-CNRS</rights><rights>Copyright © 2010. Published by Elsevier Ireland Ltd.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=25539379$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20970202$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>BABU-NARAYAN, Sonya V</creatorcontrib><creatorcontrib>UEBING, Anselm</creatorcontrib><creatorcontrib>KILNER, Philip J</creatorcontrib><creatorcontrib>WEI LI</creatorcontrib><creatorcontrib>GATZOULIS, Michael A</creatorcontrib><creatorcontrib>DAVLOUROS, Periklis A</creatorcontrib><creatorcontrib>KEMP, Michael</creatorcontrib><creatorcontrib>DAVIDSON, Simon</creatorcontrib><creatorcontrib>DIMOPOULOS, Konstantinos</creatorcontrib><creatorcontrib>BAYNE, Stephanie</creatorcontrib><creatorcontrib>PENNELL, Dudley J</creatorcontrib><creatorcontrib>GIBSON, Derek G</creatorcontrib><creatorcontrib>FLATHER, Marcus</creatorcontrib><title>Randomised trial of ramipril in repaired tetralogy of Fallot and pulmonary regurgitation The APPROPRIATE study (Ace inhibitors for Potential PRevention Of the deleterious effects of Pulmonary Regurgitation In Adults with repaired TEtralogy of Fallot)</title><title>International journal of cardiology</title><addtitle>Int J Cardiol</addtitle><description>Optimal treatment for stable repaired tetralogy of Fallot (rTOF) patients with pulmonary regurgitation (PR) and related right ventricular (RV) dilatation, including timing of valve implantation, remains uncertain. We sought to study tolerability of the angiotensin-converting-enzyme (ACE) inhibitor ramipril and its effects on cardiovascular function in these patients.
Clinically stable rTOF patients with moderate/severe PR were included. A double-blinded, placebo-controlled study of 6 months of ramipril vs placebo was performed. All patients underwent cardiovascular magnetic resonance (CMR), echocardiography, neurohormonal analysis, and objective cardiopulmonary exercise testing at baseline and follow-up.
The main aim was to detect changes in RV function (primary endpoint CMR-derived RV ejection fraction).
Seventy-two patients were enrolled and 64 qualified for the final analysis. There was no difference in the primary endpoint RV ejection fraction. RV long-axis shortening significantly improved in the ramipril group compared to placebo (RV: 2.3 ± 3.8 vs 0.02 ± 2.7 mm; P=0.017) as did LV long-axis shortening (1.9 ± 4.5 vs -0.2 ± 3.7 mm respectively; P=0.030). No clear differences were detected between ramipril and placebo for other measures. In a subgroup of patients with restrictive RV physiology, ramipril resulted in decrease in LV end-systolic volume index and increase in LVEF (-2.4 ± 5.0 vs 2.7 ± 3.6 mL/m(2); P=0.005, 2.5 ± 5.0 vs -1.3 ± 3.5%; P=0.03). Ramipril did not cause adverse events and was well tolerated.
Ramipril is a well tolerated therapy, improves biventricular function in patients with rTOF and may have a particular role in patients with restrictive RV physiology. Larger, longer-term studies are needed to determine if ACE inhibitors can improve both ventricular remodelling and clinical outcomes. (
97515585).</description><subject>Angiotensin-Converting Enzyme Inhibitors - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Cardiology. Vascular system</subject><subject>Congenital heart diseases. Malformations of the aorta, pulmonary vessels and vena cava</subject><subject>Double-Blind Method</subject><subject>Endocardial and cardiac valvular diseases</subject><subject>Feasibility Studies</subject><subject>Heart</subject><subject>Humans</subject><subject>Medical sciences</subject><subject>Prospective Studies</subject><subject>Pulmonary Valve Insufficiency - complications</subject><subject>Pulmonary Valve Insufficiency - physiopathology</subject><subject>Ramipril - therapeutic use</subject><subject>Tetralogy of Fallot - complications</subject><subject>Tetralogy of Fallot - physiopathology</subject><subject>Tetralogy of Fallot - surgery</subject><subject>Time Factors</subject><subject>Ventricular Function - drug effects</subject><issn>0167-5273</issn><issn>1874-1754</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNplkcGO0zAQhi0EYsvCGyDkCwIOKXac2MkxWnWh0kqNonKuHGfSunLiYDuL-uqccERhhTjNaPzN_894EHpLyZoSyj-f1_qspOvWKYklUq5JLp6hFS1EllCRZ8_RKmIiyVPBbtAr78-EkKwsi5foJiWlIClJV-hnI8fODtpDh4PT0mDbYycHPTltsB6xg0lqt7xCcNLY42Uh7qUxNuDYi6fZDHaU7hLR4-yOOsig7Yj3J8BVXTe7utlW-w32Ye4u-GOlIMqedKuDdR731uHaBhjD4l038LiksX3X4xAVOjAQwGk7ewx9Dyr4xb_-a9r8Y7odcdXNJkI_dDg9Db_f_Df8p9foRS-NhzfXeIu-3W_2d1-Th92X7V31kExpRkJScFbmXUuE6Lks8lZylRIuiGol5YUC1nWMtsCZKKAsSJaXkpI0hTZmXLGU3aIPv3UnZ7_P4MMhfrcCY-QIca1DSQXlNOc8ku-u5NwO0B3iDYa44-HPuSLw_gpIr6TpnRyV9k9cnrOSiZL9AhF9q2A</recordid><startdate>20120209</startdate><enddate>20120209</enddate><creator>BABU-NARAYAN, Sonya V</creator><creator>UEBING, Anselm</creator><creator>KILNER, Philip J</creator><creator>WEI LI</creator><creator>GATZOULIS, Michael A</creator><creator>DAVLOUROS, Periklis A</creator><creator>KEMP, Michael</creator><creator>DAVIDSON, Simon</creator><creator>DIMOPOULOS, Konstantinos</creator><creator>BAYNE, Stephanie</creator><creator>PENNELL, Dudley J</creator><creator>GIBSON, Derek G</creator><creator>FLATHER, Marcus</creator><general>Elsevier</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>20120209</creationdate><title>Randomised trial of ramipril in repaired tetralogy of Fallot and pulmonary regurgitation The APPROPRIATE study (Ace inhibitors for Potential PRevention Of the deleterious effects of Pulmonary Regurgitation In Adults with repaired TEtralogy of Fallot)</title><author>BABU-NARAYAN, Sonya V ; UEBING, Anselm ; KILNER, Philip J ; WEI LI ; GATZOULIS, Michael A ; DAVLOUROS, Periklis A ; KEMP, Michael ; DAVIDSON, Simon ; DIMOPOULOS, Konstantinos ; BAYNE, Stephanie ; PENNELL, Dudley J ; GIBSON, Derek G ; FLATHER, Marcus</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p240t-86395db077f6a85ba6c20670cba168ce3dd31be6378e980459a1022eb4596c323</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Angiotensin-Converting Enzyme Inhibitors - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Cardiology. Vascular system</topic><topic>Congenital heart diseases. Malformations of the aorta, pulmonary vessels and vena cava</topic><topic>Double-Blind Method</topic><topic>Endocardial and cardiac valvular diseases</topic><topic>Feasibility Studies</topic><topic>Heart</topic><topic>Humans</topic><topic>Medical sciences</topic><topic>Prospective Studies</topic><topic>Pulmonary Valve Insufficiency - complications</topic><topic>Pulmonary Valve Insufficiency - physiopathology</topic><topic>Ramipril - therapeutic use</topic><topic>Tetralogy of Fallot - complications</topic><topic>Tetralogy of Fallot - physiopathology</topic><topic>Tetralogy of Fallot - surgery</topic><topic>Time Factors</topic><topic>Ventricular Function - drug effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>BABU-NARAYAN, Sonya V</creatorcontrib><creatorcontrib>UEBING, Anselm</creatorcontrib><creatorcontrib>KILNER, Philip J</creatorcontrib><creatorcontrib>WEI LI</creatorcontrib><creatorcontrib>GATZOULIS, Michael A</creatorcontrib><creatorcontrib>DAVLOUROS, Periklis A</creatorcontrib><creatorcontrib>KEMP, Michael</creatorcontrib><creatorcontrib>DAVIDSON, Simon</creatorcontrib><creatorcontrib>DIMOPOULOS, Konstantinos</creatorcontrib><creatorcontrib>BAYNE, Stephanie</creatorcontrib><creatorcontrib>PENNELL, Dudley J</creatorcontrib><creatorcontrib>GIBSON, Derek G</creatorcontrib><creatorcontrib>FLATHER, Marcus</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>International journal of cardiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>BABU-NARAYAN, Sonya V</au><au>UEBING, Anselm</au><au>KILNER, Philip J</au><au>WEI LI</au><au>GATZOULIS, Michael A</au><au>DAVLOUROS, Periklis A</au><au>KEMP, Michael</au><au>DAVIDSON, Simon</au><au>DIMOPOULOS, Konstantinos</au><au>BAYNE, Stephanie</au><au>PENNELL, Dudley J</au><au>GIBSON, Derek G</au><au>FLATHER, Marcus</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomised trial of ramipril in repaired tetralogy of Fallot and pulmonary regurgitation The APPROPRIATE study (Ace inhibitors for Potential PRevention Of the deleterious effects of Pulmonary Regurgitation In Adults with repaired TEtralogy of Fallot)</atitle><jtitle>International journal of cardiology</jtitle><addtitle>Int J Cardiol</addtitle><date>2012-02-09</date><risdate>2012</risdate><volume>154</volume><issue>3</issue><spage>299</spage><epage>305</epage><pages>299-305</pages><issn>0167-5273</issn><eissn>1874-1754</eissn><coden>IJCDD5</coden><abstract>Optimal treatment for stable repaired tetralogy of Fallot (rTOF) patients with pulmonary regurgitation (PR) and related right ventricular (RV) dilatation, including timing of valve implantation, remains uncertain. We sought to study tolerability of the angiotensin-converting-enzyme (ACE) inhibitor ramipril and its effects on cardiovascular function in these patients.
Clinically stable rTOF patients with moderate/severe PR were included. A double-blinded, placebo-controlled study of 6 months of ramipril vs placebo was performed. All patients underwent cardiovascular magnetic resonance (CMR), echocardiography, neurohormonal analysis, and objective cardiopulmonary exercise testing at baseline and follow-up.
The main aim was to detect changes in RV function (primary endpoint CMR-derived RV ejection fraction).
Seventy-two patients were enrolled and 64 qualified for the final analysis. There was no difference in the primary endpoint RV ejection fraction. RV long-axis shortening significantly improved in the ramipril group compared to placebo (RV: 2.3 ± 3.8 vs 0.02 ± 2.7 mm; P=0.017) as did LV long-axis shortening (1.9 ± 4.5 vs -0.2 ± 3.7 mm respectively; P=0.030). No clear differences were detected between ramipril and placebo for other measures. In a subgroup of patients with restrictive RV physiology, ramipril resulted in decrease in LV end-systolic volume index and increase in LVEF (-2.4 ± 5.0 vs 2.7 ± 3.6 mL/m(2); P=0.005, 2.5 ± 5.0 vs -1.3 ± 3.5%; P=0.03). Ramipril did not cause adverse events and was well tolerated.
Ramipril is a well tolerated therapy, improves biventricular function in patients with rTOF and may have a particular role in patients with restrictive RV physiology. Larger, longer-term studies are needed to determine if ACE inhibitors can improve both ventricular remodelling and clinical outcomes. (
97515585).</abstract><cop>Shannon</cop><pub>Elsevier</pub><pmid>20970202</pmid><doi>10.1016/j.ijcard.2010.09.057</doi><tpages>7</tpages></addata></record> |
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| subjects | Angiotensin-Converting Enzyme Inhibitors - therapeutic use Biological and medical sciences Cardiology. Vascular system Congenital heart diseases. Malformations of the aorta, pulmonary vessels and vena cava Double-Blind Method Endocardial and cardiac valvular diseases Feasibility Studies Heart Humans Medical sciences Prospective Studies Pulmonary Valve Insufficiency - complications Pulmonary Valve Insufficiency - physiopathology Ramipril - therapeutic use Tetralogy of Fallot - complications Tetralogy of Fallot - physiopathology Tetralogy of Fallot - surgery Time Factors Ventricular Function - drug effects |
| title | Randomised trial of ramipril in repaired tetralogy of Fallot and pulmonary regurgitation The APPROPRIATE study (Ace inhibitors for Potential PRevention Of the deleterious effects of Pulmonary Regurgitation In Adults with repaired TEtralogy of Fallot) |
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