Effect of Genetic Polymorphism on the Clinical Outcome of Patients With Heart Failure (SNPs)
Effect of Genetic Polymorphism on the Clinical Outcome, Echocardiographic Parameters and Cardiac Biomarkers of Patients With Heart Failure
調査の概要
状態
条件
詳細な説明
In the past decade there has been considerable progress in cardiovascular pharmacogenetics and pharmacogenomics. Although drug response variation in Heart Failure is likely multifactorial, pharmacogenetic variation may partially account for therapeutic failure contributing to the remaining high mortality in HF. Identifying novel gene variants affecting treatment response may reveal unrecognized pathways and new potential therapeutic targets. Few studies to date have attempted to assess the extent to which variation in drug response was exclusively due to genetic factors and therefore expounding the likely clinical benefit of using pharmacogenetics to guide HF therapy. One of the prerequisites to bridging this gap is to consider likely trial designs and criteria that will lead to a consensus upon using pharmacogenetics-based variants to guide therapy in clinical practice.
Another area gaining momentum is tailoring medication in response to biomarker levels as there is considerable evidence for the relationship between remodeling and fibrosis markers levels and worse prognosis in those with HF. Moreover,investigation into the proteomics of HF may also reveal variation that can be used to guide HF therapy hand-in-hand with biomarkers and pharmacogenomics, which would facilitate bridging the gap of genotype and phenotype. Disparity between genotype and phenotype may also account for the inconsistent results with current SNPs, further appreciation of this relationship would be a significant step forward.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Cairo、エジプト
- Ain Shams University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Heart failure patients NYHA class II to IV.
- Left ventricular ejection fraction (LVEF) < 45%
- Written informed consent of the subject to participate in the study.
- Newly diagnosed patients who will be treated with BBs and ACEIs/or ARBs.
- Patients who are candidate for add-on treatment with Spironolactone / Eplerenone.
- Age of 18 years to 80 years.
Exclusion Criteria:
- Contraindication to BBsor ACEIs.
- Contraindication to Spironolactone / Eplerenone.
- Patients who received previous treatment with Spironolactone / Eplerenone.
- Sig CAD, CABG, PCI, or valve surgery within 3 months.
- Mild-to-severe valvular stenosis or severe (grade III/IV) valvular regurgitation
- Pregnant or nursing women.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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Cohort A
Newly diagnosed Heart Failure patients who will be treated with beta blockers (BB) and Angiotensin converting enzyme inhibitors (ACEIs)/or Angiotensin receptor blockers (ARBs) for the first time.
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Cohort B
Heart Failure patients who are candidate for add-on treatment with Spironolactone / Eplerenone.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
RAAS genes and Clinical Outcome
時間枠:6 months
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Association between RAAS genetic polymorphism and clinical response, Cardiac remodeling and Fibrosis biomarkers and echocardiographic outcome of patients with heart failure.
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6 months
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Adrenergic receptors genes and Clinical Outcome
時間枠:6 months
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Association between Adrenergic receptors genetic polymorphism and clinical response, Cardiac remodeling and Fibrosis biomarkers and echocardiographic outcome of patients with heart failure.
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6 months
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Cardiac Fibrosis genes and Clinical Outcome
時間枠:6 months
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Association between Cardiac Fibrosis genes genetic polymorphism and clinical response, Cardiac remodeling and Fibrosis biomarkers and echocardiographic outcome of patients with heart failure.
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6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Overall patients' clinical outcome
時間枠:12 months
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Potential interaction between these target genes polymorphism and the overall patients' clinical outcome, mortality and response to treatment of heart failure.
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12 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Neven M. Sarhan, MSc、Misr International University
- スタディチェア:Nagwa A. Sabri, PhD、Ain Shams University
- スタディディレクター:Mona F. Schaalan, PhD、Misr International University
- スタディディレクター:Lamiaa M. Elwakeel, PhD、Ain Shams University
- スタディディレクター:Hazem M. Khorshid, MD、Ain Shams University
- スタディディレクター:Mohamed H. Solyaman, PhD、Ain Shams University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
心不全の臨床試験
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Novartis Pharmaceuticals完了EC-MPS による治療に関心があり、コア研究の 12 か月の治療期間を無事に完了した患者 (de novo Heart Recipients)