Browsing by Author "Garza, Dahlia"

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    Cardiovascular outcome trials in patients with chronic kidney disease: challenges associated with selection of patients and endpoints
    (Oxford Academic, 2019-03-14) Rossignol, Patrick; Agarwal, Rajiv; Canaud, Bernard; Charney, Alan; Chatellier, Gilles; Craig, Jonathan C.; Cushman, William C.; Gansevoort, Ronald T.; Fellström, Bengt; Garza, Dahlia; Guzman, Nicolas; Holtkamp, Frank A.; London, Gerard M.; Massy, Ziad A.; Mebazaa, Alexandre; Mol, Peter G.M.; Pfeffer, Marc A.; Rosenberg, Yves; Ruilope, Luis M.; Seltzer, Jonathan; Shah, Amil M.; Shah, Salim; Singh, Bhupinder; Stefánsson, Bergur V.; Stockbridge, Norman; Gattis Stough, Wendy; Thygesen, Kristian; Walsh, Michael; Wanner, Christoph; Warnock, David G.; Wilcox, Christopher S.; Wittes, Janet; Pitt, Bertram; Thompson, Aliza; Zannad, Faiez; Medicine, School of Medicine
    Although cardiovascular disease is a major health burden for patients with chronic kidney disease, most cardiovascular outcome trials have excluded patients with advanced chronic kidney disease. Moreover, the major cardiovascular outcome trials that have been conducted in patients with end-stage renal disease have not demonstrated a treatment benefit. Thus, clinicians have limited evidence to guide the management of cardiovascular disease in patients with chronic kidney disease, particularly those on dialysis. Several factors contribute to both the paucity of trials and the apparent lack of observed treatment effect in completed studies. Challenges associated with conducting trials in this population include patient heterogeneity, complexity of renal pathophysiology and its interaction with cardiovascular disease, and competing risks for death. The Investigator Network Initiative Cardiovascular and Renal Clinical Trialists (INI-CRCT), an international organization of academic cardiovascular and renal clinical trialists, held a meeting of regulators and experts in nephrology, cardiology, and clinical trial methodology. The group identified several research priorities, summarized in this paper, that should be pursued to advance the field towards achieving improved cardiovascular outcomes for these patients. Cardiovascular and renal clinical trialists must partner to address the uncertainties in the field through collaborative research and design clinical trials that reflect the specific needs of the chronic and end-stage kidney disease populations, with the shared goal of generating robust evidence to guide the management of cardiovascular disease in patients with kidney disease.
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    Patiromer to Enable Spironolactone Use in the Treatment of Patients with Resistant Hypertension and Chronic Kidney Disease: Rationale and Design of the AMBER Study
    (Karger Publishers, 2018) Agarwal, Rajiv; Rossignol, Patrick; Garza, Dahlia; Mayo, Martha R.; Warren, Suzette; Arthur, Susan; Romero, Alain; White, William B.; Williams, Bryan; Medicine, School of Medicine
    BACKGROUND: While chronic kidney disease (CKD) is common in resistant hypertension (RHTN), prior studies -evaluating mineralocorticoid receptor antagonists excluded patients with reduced kidney function due to risk of hyperkalemia. AMBER (ClinicalTrials.gov identifier NCT03071263) will evaluate if the potassium-binding polymer patiromer used concomitantly with spironolactone in patients with RHTN and CKD prevents hyperkalemia and allows more persistent spironolactone use for hypertension management. METHODS: Randomized, double-blind, placebo-controlled parallel group 12-week study of patiromer and spironolactone versus placebo and spironolactone in patients with uncontrolled RHTN and CKD. RHTN is defined as unattended systolic automated office blood pressure (AOBP) of -135-160 mm Hg during screening despite taking ≥3 antihypertensives, including a diuretic, and an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker -(unless not tolerated or contraindicated). The CKD inclusion criterion is an estimated glomerular filtration rate (eGFR) of 25 to ≤45 mL/min/1.73 m2. Screening serum potassium must be 4.3-5.1 mEq/L. The primary efficacy endpoint is the between-group difference (spironolactone plus patiromer versus spironolactone plus placebo) in the proportion of patients remaining on spironolactone at Week 12. RESULTS: Baseline characteristics have been analyzed as of March 2018 for 146 (of a targeted 290) patients. Mean (SD) baseline age is 69.3 (10.9) years; 52.1% are male, 99.3% White, and 47.3% have diabetes. Mean (SD) baseline serum potassium is 4.68 (0.25) mEq/L, systolic AOBP is 144.3 (6.8) mm Hg, eGFR is 35.7 (7.7) mL/min/1.73 m2. CONCLUSION: AMBER will define the ability of patiromer to facilitate the use of spironolactone, an effective antihypertensive therapy for patients with RHTN and CKD.