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临床试验/NCT06296862
NCT06296862尚未招募不适用

Effect of Dietary Approaches to Stop Hypertension Diet on Heart Failure Status in Older Adults

University of Georgia2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2024年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
38
试验地点
2
主要终点
B-natriuretic peptide (BNP)

研究概览

简要总结

The purpose of this study is to examine the effect of the Dietary Approaches to Stop Hypertension (DASH) diet has on heart failure status in older adults. This study is important because it may provide a low-cost strategy to help reduce hospitalizations and deaths for heart failure patients. Participants will be adults age 65 and older with heart failure. They will have 4 study visits, each lasting about 2 hours, and will be in the study for 12 weeks. They will also be asked about their dietary consumption 6 times, each time lasting about 45 minutes. All in-person study visits will take place in the Emory GCRC. Participants will have physical exams, body measurements, blood tests, urinalysis, chart review, and answer surveys. They will be randomized to eat only the DASH diet provided to them for 4 weeks either at the beginning or end of their participation in the study. Participants will be recruited from heart failure patients at Emory University Hospital, Emory University Hospital Midtown, and Emory Outpatient Advanced Heart Failure Therapy Center. The total enrollment planned under Emory's oversight, accounting for screen failures and withdrawals, will be n=38 participants. The study team will obtain informed consent prior to the first study visit either in person, or, alternatively, over the phone, if requested by participants. Specimens and data obtained in this study will not be banked for future use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
65 Years 至 110 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 65+ years of age
  • Heart failure diagnosis and symptoms, as outlined by the 2021 European Society of Cardiology diagnostic guidelines
  • Residence within 50 miles of Emory University
  • Have undergone hemodynamic monitoring device implantation (CardioMEMS, Abbott)
  • Have received optimized HF therapy for 3+ months post CardioMEMS implantation

排除标准

  • Heart failure-related hospitalization or heart failure medication changes within 1 month
  • Renal disease stages IV-V
  • Expected survival < 12 months
  • Dementia or Alzheimer's disease
  • Limited English literacy and communication skills

研究组 & 干预措施

Dietary Approaches to Stop Hypertension Diet

Experimental

干预措施: Dietary Approaches to Stop Hypertension Diet (Other)

Usual Diet

No Intervention

结局指标

主要结局

B-natriuretic peptide (BNP)

时间窗: Study visit 1-4

Clinically relevant natriuretic peptide

次要结局

  • N-terminal-proBNP (NT-proBNP)(Study visit 1-4)
  • Systolic and Diastolic Pulmonary Artery Pressures(Patient-driven measurement data points during intervention/control phase (8 weeks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elisabeth Lilian Pia Sattler, Ph.D., B.S. Pharm

Assistant Professor

University of Georgia

研究点 (2)

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