drugset / Trial / NCT00000516
Studies of Left Ventricular Dysfunction (SOLVD)
RandomizedDouble-blindPrevention
Summary
To determine if enalapril treatment of left ventricular dysfunction (LVD) due to ischemic or hypertensive heart disease led to reduced mortality and morbidity in symptomatic and asymptomatic patients. There were a Prevention Trial, a Treatment Trial, and a registry.
Timeline
- Start
- 1985-07
- Primary completion
- —
- Completion
- 1990-05
Publications
- Background Konstam MA, Kronenberg MW, Udelson JE, Metherall J, Dolan N, Edens TR, Howe DM, Yusuf S, Youngblood M, Toltsis H. Effect of acute angiotensin converting enzyme inhibition on left ventricular filling in patients with congestive heart failure. Relation to right ventricular volumes. Circulation. 1990 Feb;81(2 Suppl):III115-22.
- Background Studies of left ventricular dysfunction (SOLVD)--rationale, design and methods: two trials that evaluate the effect of enalapril in patients with reduced ejection fraction. Am J Cardiol. 1990 Aug 1;66(3):315-22. doi: 10.1016/0002-9149(90)90842-o.
- Background Francis GS, Benedict C, Johnstone DE, Kirlin PC, Nicklas J, Liang CS, Kubo SH, Rudin-Toretsky E, Yusuf S. Comparison of neuroendocrine activation in patients with left ventricular dysfunction with and without congestive heart failure. A substudy of the Studies of Left Ventricular Dysfunction (SOLVD). Circulation. 1990 Nov;82(5):1724-9. doi: 10.1161/01.cir.82.5.1724.
- Background SOLVD Investigators; Yusuf S, Pitt B, Davis CE, Hood WB, Cohn JN. Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. N Engl J Med. 1991 Aug 1;325(5):293-302. doi: 10.1056/NEJM199108013250501.
- Background Hood WB Jr, Youngblood M, Ghali JK, Reid M, Rogers WJ, Howe D, Teo KK, LeJemtel TH. Initial blood pressure response to enalapril in hospitalized patients (Studies of Left Ventricular Dysfunction [SOLVD]). Am J Cardiol. 1991 Dec 1;68(15):1465-8. doi: 10.1016/0002-9149(91)90280-x.
- Background SOLVD Investigators; Yusuf S, Pitt B, Davis CE, Hood WB Jr, Cohn JN. Effect of enalapril on mortality and the development of heart failure in asymptomatic patients with reduced left ventricular ejection fractions. N Engl J Med. 1992 Sep 3;327(10):685-91. doi: 10.1056/NEJM199209033271003.
- Background Konstam MA, Rousseau MF, Kronenberg MW, Udelson JE, Melin J, Stewart D, Dolan N, Edens TR, Ahn S, Kinan D, et al. Effects of the angiotensin converting enzyme inhibitor enalapril on the long-term progression of left ventricular dysfunction in patients with heart failure. SOLVD Investigators. Circulation. 1992 Aug;86(2):431-8. doi: 10.1161/01.cir.86.2.431.
- Background Liang CS, Stewart DK, LeJemtel TH, Kirlin PC, McIntyre KM, Robertson HT, Brown R, Moore AW, Wellington KL, Cahill L, et al. Characteristics of peak aerobic capacity in symptomatic and asymptomatic subjects with left ventricular dysfunction. The Studies of Left Ventricular Dysfunction (SOLVD) Investigators. Am J Cardiol. 1992 May 1;69(14):1207-11. doi: 10.1016/0002-9149(92)90937-t.
- Background Konstam MA, Kronenberg MW, Udelson JE, Kinan D, Metherall J, Dolan N, Edens T, Howe D, Kilcoyne L, Benedict C, et al. Effectiveness of preload reserve as a determinant of clinical status in patients with left ventricular systolic dysfunction. The SOLVD Investigators. Am J Cardiol. 1992 Jun 15;69(19):1591-5. doi: 10.1016/0002-9149(92)90709-8.
- Background Carew BD, Ahn SA, Boichot HD, Dierenfeldt BJ, Dolan NA, Edens TR, Weiner DH, Probstfield JL. Recruitment strategies in the studies of left ventricular dysfunction (SOLVD): strategies for screening and enrollment in two concurrent but separate trials. The SOLVD Investigators. Control Clin Trials. 1992 Oct;13(5):325-38. doi: 10.1016/0197-2456(92)90035-x.
- Background Johnstone D, Limacher M, Rousseau M, Liang CS, Ekelund L, Herman M, Stewart D, Guillotte M, Bjerken G, Gaasch W, et al. Clinical characteristics of patients in studies of left ventricular dysfunction (SOLVD). Am J Cardiol. 1992 Oct 1;70(9):894-900. doi: 10.1016/0002-9149(92)90734-g.
- Background Pouleur H. Results of the treatment trial of the studies of left ventricular dysfunction (SOLVD). The SOLVD Investigators. Am J Cardiol. 1992 Oct 8;70(10):135C-136C. doi: 10.1016/0002-9149(92)91372-b. No abstract available.
- Background Bangdiwala SI, Weiner DH, Bourassa MG, Friesinger GC 2nd, Ghali JK, Yusuf S. Studies of Left Ventricular Dysfunction (SOLVD) Registry: rationale, design, methods and description of baseline characteristics. Am J Cardiol. 1992 Aug 1;70(3):347-53. doi: 10.1016/0002-9149(92)90617-8.
- Background Pouleur H, Rousseau MF, van Eyll C, Stoleru L, Hayashida W, Udelson JA, Dolan N, Kinan D, Gallagher P, Ahn S, et al. Effects of long-term enalapril therapy on left ventricular diastolic properties in patients with depressed ejection fraction. SOLVD Investigators. Circulation. 1993 Aug;88(2):481-91. doi: 10.1161/01.cir.88.2.481.
- Background Gorkin L, Norvell NK, Rosen RC, Charles E, Shumaker SA, McIntyre KM, Capone RJ, Kostis J, Niaura R, Woods P, et al. Assessment of quality of life as observed from the baseline data of the Studies of Left Ventricular Dysfunction (SOLVD) trial quality-of-life substudy. Am J Cardiol. 1993 May 1;71(12):1069-73. doi: 10.1016/0002-9149(93)90575-w.
- Background Bourassa MG, Gurne O, Bangdiwala SI, Ghali JK, Young JB, Rousseau M, Johnstone DE, Yusuf S. Natural history and patterns of current practice in heart failure. The Studies of Left Ventricular Dysfunction (SOLVD) Investigators. J Am Coll Cardiol. 1993 Oct;22(4 Suppl A):14A-19A. doi: 10.1016/0735-1097(93)90456-b.
- Background Pouleur HG, Konstam MA, Udelson JE, Rousseau MF. Changes in ventricular volume, wall thickness and wall stress during progression of left ventricular dysfunction. The SOLVD Investigators. J Am Coll Cardiol. 1993 Oct;22(4 Suppl A):43A-48A. doi: 10.1016/0735-1097(93)90462-a.
- Background Benedict CR, Weiner DH, Johnstone DE, Bourassa MG, Ghali JK, Nicklas J, Kirlin P, Greenberg B, Quinones MA, Yusuf S. Comparative neurohormonal responses in patients with preserved and impaired left ventricular ejection fraction: results of the Studies of Left Ventricular Dysfunction (SOLVD) Registry. The SOLVD Investigators. J Am Coll Cardiol. 1993 Oct;22(4 Suppl A):146A-153A. doi: 10.1016/0735-1097(93)90480-o.
- Background Bittner V, Weiner DH, Yusuf S, Rogers WJ, McIntyre KM, Bangdiwala SI, Kronenberg MW, Kostis JB, Kohn RM, Guillotte M, et al. Prediction of mortality and morbidity with a 6-minute walk test in patients with left ventricular dysfunction. SOLVD Investigators. JAMA. 1993 Oct 13;270(14):1702-7.
- Background Pouleur H, Rousseau MF, van Eyll C, Melin J, Youngblood M, Yusuf S. Cardiac mechanics during development of heart failure. SOLVD Investigators. Circulation. 1993 May;87(5 Suppl):IV14-20.
- Background Konstam MA, Kronenberg MW, Rousseau MF, Udelson JE, Melin J, Stewart D, Dolan N, Edens TR, Ahn S, Kinan D, et al. Effects of the angiotensin converting enzyme inhibitor enalapril on the long-term progression of left ventricular dilatation in patients with asymptomatic systolic dysfunction. SOLVD (Studies of Left Ventricular Dysfunction) Investigators. Circulation. 1993 Nov;88(5 Pt 1):2277-83. doi: 10.1161/01.cir.88.5.2277.
- Background Yusuf S, Garg R, McConachie D. Effect of angiotensin-converting enzyme inhibitors in left ventricular dysfunction: results of the studies of left ventricular dysfunction in the context of other similar trials. J Cardiovasc Pharmacol. 1993;22 Suppl 9:S28-35.
- Background Hayashida W, Van Eyll C, Rousseau MF, Pouleur H. Regional remodeling and nonuniform changes in diastolic function in patients with left ventricular dysfunction: modification by long-term enalapril treatment. The SOLVD Investigators. J Am Coll Cardiol. 1993 Nov 1;22(5):1403-10. doi: 10.1016/0735-1097(93)90550-k.
- Background Melin JA, Konstam MA, Rousseau MF, Pouleur H. Progression of left ventricular dysfunction in patients with heart failure. SOLVD Investigators. The Studies of Left Ventricular Dysfunction. Ann Ital Med Int. 1993 Oct;8 Suppl:9S. No abstract available.
- Background Rogers WJ, Johnstone DE, Yusuf S, Weiner DH, Gallagher P, Bittner VA, Ahn S, Schron E, Shumaker SA, Sheffield LT. Quality of life among 5,025 patients with left ventricular dysfunction randomized between placebo and enalapril: the Studies of Left Ventricular Dysfunction. The SOLVD Investigators. J Am Coll Cardiol. 1994 Feb;23(2):393-400. doi: 10.1016/0735-1097(94)90426-x.
- Background Kostis JB, Shelton BJ, Yusuf S, Weiss MB, Capone RJ, Pepine CJ, Gosselin G, Delahaye F, Probstfield JL, Cahill L, et al. Tolerability of enalapril initiation by patients with left ventricular dysfunction: results of the medication challenge phase of the Studies of Left Ventricular Dysfunction. Am Heart J. 1994 Aug;128(2):358-64. doi: 10.1016/0002-8703(94)90490-1.
- Background Henzlova MJ, Blackburn GH, Bradley EJ, Rogers WJ. Patient perception of a long-term clinical trial: experience using a close-out questionnaire in the Studies of Left Ventricular Dysfunction (SOLVD) Trial. SOLVD Close-out Working Group. Control Clin Trials. 1994 Aug;15(4):284-93. doi: 10.1016/0197-2456(94)90044-2.
- Background Benedict CR, Johnstone DE, Weiner DH, Bourassa MG, Bittner V, Kay R, Kirlin P, Greenberg B, Kohn RM, Nicklas JM, et al. Relation of neurohumoral activation to clinical variables and degree of ventricular dysfunction: a report from the Registry of Studies of Left Ventricular Dysfunction. SOLVD Investigators. J Am Coll Cardiol. 1994 May;23(6):1410-20. doi: 10.1016/0735-1097(94)90385-9.
- Background LeJemtel TH, Liang CS, Stewart DK, Kirlin PC, McIntyre KM, Robertson TH, Moore A, Cahill L, Galvao M, Wellington KL, et al. Reduced peak aerobic capacity in asymptomatic left ventricular systolic dysfunction. A substudy of the studies of left ventricular dysfunction (SOLVD). SOLVD Investigator. Studies of Left Ventricular Dysfunction. Circulation. 1994 Dec;90(6):2757-60. doi: 10.1161/01.cir.90.6.2757.
- Background Yusuf S, Pepine CJ, Garces C, Pouleur H, Salem D, Kostis J, Benedict C, Rousseau M, Bourassa M, Pitt B. Effect of enalapril on myocardial infarction and unstable angina in patients with low ejection fractions. Lancet. 1992 Nov 14;340(8829):1173-8. doi: 10.1016/0140-6736(92)92889-n.
- Background Pratt CM, Gardner M, Pepine C, Kohn R, Young JB, Greenberg B, Capone R, Kostis J, Henzlova M, Gosselin G, et al. Lack of long-term ventricular arrhythmia reduction by enalapril in heart failure. SOLVD Investigators. Am J Cardiol. 1995 Jun 15;75(17):1244-9. doi: 10.1016/s0002-9149(99)80771-1.
- Background Benedict CR, Francis GS, Shelton B, Johnstone DE, Kubo SH, Kirlin P, Nicklas J, Liang CS, Konstam MA, Greenberg B, et al. Effect of long-term enalapril therapy on neurohormones in patients with left ventricular dysfunction. SOLVD Investigators. Am J Cardiol. 1995 Jun 1;75(16):1151-7. doi: 10.1016/s0002-9149(99)80748-6.
- Background Kostis JB, Shelton B, Gosselin G, Goulet C, Hood WB Jr, Kohn RM, Kubo SH, Schron E, Weiss MB, Willis PW 3rd, Young JB, Probstfield J. Adverse effects of enalapril in the Studies of Left Ventricular Dysfunction (SOLVD). SOLVD Investigators. Am Heart J. 1996 Feb;131(2):350-5. doi: 10.1016/s0002-8703(96)90365-8.
- Background Torre-Amione G, Kapadia S, Benedict C, Oral H, Young JB, Mann DL. Proinflammatory cytokine levels in patients with depressed left ventricular ejection fraction: a report from the Studies of Left Ventricular Dysfunction (SOLVD). J Am Coll Cardiol. 1996 Apr;27(5):1201-6. doi: 10.1016/0735-1097(95)00589-7.
- Background Kirlin PC, Benedict C, Shelton BJ, Francis G, Nicklas J, Liang CS, Kubo S, Johnstone D, Probstfield J, Yusuf S. Neurohumoral variability in left ventricular dysfunction. SOLVD Investigators. Studies of Left Ventricular Dysfunction. Am J Cardiol. 1995 Feb 15;75(5):354-9. doi: 10.1016/s0002-9149(99)80553-0.
- Background Greenberg B, Quinones MA, Koilpillai C, Limacher M, Shindler D, Benedict C, Shelton B. Effects of long-term enalapril therapy on cardiac structure and function in patients with left ventricular dysfunction. Results of the SOLVD echocardiography substudy. Circulation. 1995 May 15;91(10):2573-81. doi: 10.1161/01.cir.91.10.2573.
- Background Young JB, Weiner DH, Yusuf S, Pratt CM, Kostis JB, Weiss MB, Schroeder E, Guillote M. Patterns of medication use in patients with heart failure: a report from the Registry of Studies of Left Ventricular Dysfunction (SOLVD). South Med J. 1995 May;88(5):514-23. doi: 10.1097/00007611-199505000-00002.
- Background Shindler DM, Kostis JB, Yusuf S, Quinones MA, Pitt B, Stewart D, Pinkett T, Ghali JK, Wilson AC. Diabetes mellitus, a predictor of morbidity and mortality in the Studies of Left Ventricular Dysfunction (SOLVD) Trials and Registry. Am J Cardiol. 1996 May 1;77(11):1017-20. doi: 10.1016/s0002-9149(97)89163-1.
- Background Konstam V, Salem D, Pouleur H, Kostis J, Gorkin L, Shumaker S, Mottard I, Woods P, Konstam MA, Yusuf S. Baseline quality of life as a predictor of mortality and hospitalization in 5,025 patients with congestive heart failure. SOLVD Investigations. Studies of Left Ventricular Dysfunction Investigators. Am J Cardiol. 1996 Oct 15;78(8):890-5. doi: 10.1016/s0002-9149(96)00463-8.
- Background Dries DL, Rosenberg YD, Waclawiw MA, Domanski MJ. Ejection fraction and risk of thromboembolic events in patients with systolic dysfunction and sinus rhythm: evidence for gender differences in the studies of left ventricular dysfunction trials. J Am Coll Cardiol. 1997 Apr;29(5):1074-80. doi: 10.1016/s0735-1097(97)00019-3.
- Background Patten RD, Kronenberg MW, Benedict CR, Udelson JE, Kinan D, Stewart D, Yusuf S, Smith JJ, Kilcoyne L, Dolan N, Edens TR, Metherall J, Konstam MA. Acute and long-term effects of the angiotensin-converting enzyme inhibitor, enalapril, on adrenergic activity and sensitivity during exercise in patients with left ventricular systolic dysfunction. Am Heart J. 1997 Jul;134(1):37-43. doi: 10.1016/s0002-8703(97)70104-2.
- Background Al-Khadra AS, Salem DN, Rand WM, Udelson JE, Smith JJ, Konstam MA. Warfarin anticoagulation and survival: a cohort analysis from the Studies of Left Ventricular Dysfunction. J Am Coll Cardiol. 1998 Mar 15;31(4):749-53. doi: 10.1016/s0735-1097(98)00006-0.
- Background Dries DL, Exner DV, Gersh BJ, Domanski MJ, Waclawiw MA, Stevenson LW. Atrial fibrillation is associated with an increased risk for mortality and heart failure progression in patients with asymptomatic and symptomatic left ventricular systolic dysfunction: a retrospective analysis of the SOLVD trials. Studies of Left Ventricular Dysfunction. J Am Coll Cardiol. 1998 Sep;32(3):695-703. doi: 10.1016/s0735-1097(98)00297-6.
- Background Domanski MJ, Mitchell GF, Norman JE, Exner DV, Pitt B, Pfeffer MA. Independent prognostic information provided by sphygmomanometrically determined pulse pressure and mean arterial pressure in patients with left ventricular dysfunction. J Am Coll Cardiol. 1999 Mar 15;33(4):951-8. doi: 10.1016/s0735-1097(98)00679-2.
- Background Exner DV, Dries DL, Waclawiw MA, Shelton B, Domanski MJ. Beta-adrenergic blocking agent use and mortality in patients with asymptomatic and symptomatic left ventricular systolic dysfunction: a post hoc analysis of the Studies of Left Ventricular Dysfunction. J Am Coll Cardiol. 1999 Mar 15;33(4):916-23. doi: 10.1016/s0735-1097(98)00675-5.
- Background Dries DL, Exner DV, Gersh BJ, Cooper HA, Carson PE, Domanski MJ. Racial differences in the outcome of left ventricular dysfunction. N Engl J Med. 1999 Feb 25;340(8):609-16. doi: 10.1056/NEJM199902253400804.
- Background Kronenberg MW, Konstam MA, Edens TR, Howe DM, Dolan N, Udelson JE, Benedict C, Stewart D, Yusuf S. Factors influencing exercise performance in patients with left ventricular dysfunction. SOLVD Investigators. Studies of Left Ventricular Dysfunction. J Card Fail. 1998 Sep;4(3):159-67. doi: 10.1016/s1071-9164(98)80002-x.
- Background Rashid H, Exner DV, Mirsky I, Cooper HA, Waclawiw MA, Domanski MJ. Comparison of echocardiography and radionuclide angiography as predictors of mortality in patients with left ventricular dysfunction (studies of left ventricular dysfunction). Am J Cardiol. 1999 Aug 1;84(3):299-303. doi: 10.1016/s0002-9149(99)00280-5.
- Background Cooper HA, Exner DV, Waclawiw MA, Domanski MJ. White blood cell count and mortality in patients with ischemic and nonischemic left ventricular systolic dysfunction (an analysis of the Studies Of Left Ventricular Dysfunction [SOLVD]). Am J Cardiol. 1999 Aug 1;84(3):252-7. doi: 10.1016/s0002-9149(99)00272-6.
- Background Quinones MA, Greenberg BH, Kopelen HA, Koilpillai C, Limacher MC, Shindler DM, Shelton BJ, Weiner DH. Echocardiographic predictors of clinical outcome in patients with left ventricular dysfunction enrolled in the SOLVD registry and trials: significance of left ventricular hypertrophy. Studies of Left Ventricular Dysfunction. J Am Coll Cardiol. 2000 Apr;35(5):1237-44. doi: 10.1016/s0735-1097(00)00511-8.
- Background Riedinger MS, Dracup KA, Brecht ML. Predictors of quality of life in women with heart failure. SOLVD Investigators. Studies of Left Ventricular Dysfunction. J Heart Lung Transplant. 2000 Jun;19(6):598-608. doi: 10.1016/s1053-2498(00)00117-0.
- Background Vermes E, Tardif JC, Bourassa MG, Racine N, Levesque S, White M, Guerra PG, Ducharme A. Enalapril decreases the incidence of atrial fibrillation in patients with left ventricular dysfunction: insight from the Studies Of Left Ventricular Dysfunction (SOLVD) trials. Circulation. 2003 Jun 17;107(23):2926-31. doi: 10.1161/01.CIR.0000072793.81076.D4. Epub 2003 May 27.
- Background Domanski M, Norman J, Pitt B, Haigney M, Hanlon S, Peyster E; Studies of Left Ventricular Dysfunction. Diuretic use, progressive heart failure, and death in patients in the Studies Of Left Ventricular Dysfunction (SOLVD). J Am Coll Cardiol. 2003 Aug 20;42(4):705-8. doi: 10.1016/s0735-1097(03)00765-4.
- Background Hernandez AF, O'Connor CM. Sparing a little may save a lot: lessons from the Studies of Left Ventricular Dysfunction (SOLVD). J Am Coll Cardiol. 2003 Aug 20;42(4):709-11. doi: 10.1016/s0735-1097(03)00766-6. No abstract available.
- Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enalapril | Other / unclassified | — | — |