Relationship Between Genes Important in Blood Pressure Regulation and Blood Pressure Therapy in Hypertension
Assessment of the Relationship Between Genes That Encode Proteins Important in Blood Pressure Regulation and Blood Pressure Therapy in Patients With Hypertension
調査の概要
詳細な説明
2.1 Study Design and Protocol Overview This is a post-hoc association study of patients who have been diagnosed with high blood pressure and have been stable on medication treatment for at least 6 months. The purpose of this study is to evaluate the relationship between optimal medication therapy (or the therapy that has resulted in the most stable blood pressure for that particular patient) and the predicted optimal medication therapy based on a patient's genetic profile.
Chart reviews for the patient's history of antihypertensive therapy will be coupled with buccal swabs and blood pressure readings collected from eligible patients who have provided informed consent. The swab will be analyzed for fourteen genetic variants that are associated with antihypertensive therapy response (efficacy, side-effects).
2.2 Study Objective To assess the relationship between the drug therapy class/combination of therapy classes that resulted in the best blood pressure control for a patient vs. what the Geneticure high blood pressure panel would have predicted.
2.3 Secondary Objectives
- To assess the clinical time to achieve optimal blood pressure treatment.
- To assess the number of office visits required to achieve optimal blood pressure treatment.
研究の種類
入学 (実際)
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:
- Subject is able and willing to provide informed consent
- Subject is ≥ 30 and ≤ 70 years of age
- Subject with diagnosis of Hypertension for a minimum of 1 year
- Subject has been on the same class/classes of blood pressure medication for a minimum of 6 months. Note: A change in dosage, frequency, or specific medication is acceptable as long as there have been no changes to the class/classes of medications prescribed.
- Subject with a Body Mass Index (BMI) ≥ 19 and ≤ 35
Subject is currently prescribed and taking one of the following classes of medications alone or in combination with each other or a Ca+ channel blocker.
- Diuretics
- ACE Inhibitors
- Angiotensin Receptor Blocker (ARB)
- Beta-blockers
Exclusion Criteria:
- Subject has clinically significant kidney disease as determined by the investigator.
- Subject has clinically significant cardiac disease as determined by the investigator.
- Subject has clinically significant vascular disease as determined by the investigator.
- Subject has a diagnosis of secondary hypertension or is experiencing a complication of pregnancy.
- Subject is currently prescribed and taking any additional class of medication(s) for high blood pressure not included in the list above, with the exception of a Ca+ channel blocker.
- Subject has Systolic BP > 190 or Diastolic BP > 120 documented within the six months prior to visit.
- Subject has a regular alcohol intake of greater than 21 units per week in the past 6 months
- Subject has smoked greater than two packs of cigarettes (total) or equivalent nicotine intake in the past 6 months.
- Subject has an anticipated survival less than 12 months.
- Any other reason that the subject is inappropriate for study enrollment in the opinion of the Investigator.
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
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 |
|---|---|---|
|
Ambulatory blood pressure changes (using sphygmomanometry) in response to therapy according to genes important in blood pressure regulation
時間枠：one year
|
To assess the relationship between the drug therapy class/combination of therapy classes that resulted in the best blood pressure control for a patient vs. what the Geneticure high blood pressure panel would have predicted.
We will assess blood pressure values (systolic and diastolic blood pressure, in mmHg) at rest in patients on different blood pressure medications.
|
one year
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
The clinical time to achieve optimal blood pressure treatment
時間枠：One year
|
One year
|
|
The number of office visits required to achieve optimal blood pressure treatment.
時間枠：One year
|
One year
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Krista Kleve、RCRI
出版物と役立つリンク
一般刊行物
- Johnson MW, Sprissler R, Olson TP, Beenken GW, Snyder EM. Multi-Gene Pharmacogenetics and Blood Pressure Control in Patients with Hypertension. The FASEB Journal 30:942.1. 2016
- Johnson MW, Sprissler R, Olson TP, Beenken GW, Snyder EM. Time to Blood Pressure Control According to Drug Class in Patients with Hypertension. The FASEB Journal 30:941.12. 2016.
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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。
高血圧症の臨床試験
-
University of Sao Paulo General Hospitalまだ募集していませんCOPD | 肺疾患および/または低酸素症に続発する肺高血圧症 | Pulmnary Hypertension