Pharmacogenomics of treatment resistant hypertension a study comparing the incidence of SNVs of genes ENaC and NEDD4L in treatment resistant hypertension with controlled hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- The frequency of the risk alleles and genotypes of the two selected SNVs (ENaC
研究概览
简要总结
Based on the previous studies conducted, it was found that NEDD4L rs4149601 G-allele (GG/GA) was associated with greater SBP and DBP reduction after six months of monotherapy with Betablockers or Diuretics and better cardiovascular outcomes than AA homozygous genotype. Similarly, the SNV in ENaC R563Q rs80311498 was associated with decreased response to spironolactone in patients with TRH and that these patients might be benefited from amiloride. Thus, we can conclude that these SNVs are responsible for reduced response to Beta-blockers and Diuretics in hypertensive patients resulting in progression to TRH. No data pertaining to the genomics of Indian population in TRH is available. This study will give first hand data related to the genomics of TRH in Indian population. Through this study, we aim to compare the incidence of these SNVs in TRH with Controlled Hypertension.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Cases i.e. patients with Treatment resistant hypertension (TRH): Blood Pressure more than or equal to 130/80 mmHg and, Currently on at least three antihypertensive agents including diuretics and, Received the treatment for 3 months or more.
- •Controls i.e. patients with Controlled hypertension: Blood Pressure less than 130/80 mmHg and, Currently on three or less antihypertensive agents.
- •Willing to give written informed consent.
排除标准
- •Diagnosed CKD
- •Diagnosed secondary causes of hypertension
- •Pregnant and lactating women.
结局指标
主要结局
The frequency of the risk alleles and genotypes of the two selected SNVs (ENaC
时间窗: At baseline
(rs80311498) and NEDD4L (rs4149601)) among patients with TRH and controlled
时间窗: At baseline
hypertension, expressed as proportions and analyzed for statistical association.
时间窗: At baseline
次要结局
- Mean age at presentation stratified by genotype & correlation analysis between SNV status & age of onset using appropriate statistical tests.
- Distribution of the GRS among TRH & control patients & its predictive value in identifying TRH using logistic regression & ROC curve analysis.(At baseline)
- Internal consistency (Cronbach’s alpha), test–retest reliability (intraclass correlation coefficient) & construct/criterion validity of the newly developed questionnaire in comparison with the Hill-Bone HBP Therapy Scale, measured in terms of correlation coefficients & predictive association with blood pressure control.(At baseline)
- Stratified analysis of SNV prevalence & associations across gender (male/female) & geographic subgroups (urban/rural), identifying any significant interactions or modifiers.(At baseline)
研究者
Dr Ajay Prakash
PGIMER Chandigarh