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Dietary Approaches to Stop Hypertension in 'Diastolic' Heart Failure 2 (DASH-DHF 2)

2018년 6월 4일 업데이트: Scott L. Hummel, University of Michigan
The purpose of this study is to examine how dietary changes affect the heart and blood vessels in patients with hypertension (high blod pressure) who have a condition called 'heart failure with preserved ejection fraction" (HFPEF). This condition is also known as "diastolic heart failure" or "heart failure with normal ejection fraction", and occurs even though the heart's pumping function is normal.

연구 개요

상태

종료됨

정황

개입 / 치료

상세 설명

In an earlier study, the investigators found that patients with HFPEF who ate a special diet for three weeks had improved blood pressure control and lower levels of blood chemicals that may damage the heart and blood vessels. The eating plan in the study was based on the DASH diet, also known as the Dietary Approaches to Stop Hypertension diet. This plan is rich in fruits, vegetables, and low-fat dairy, and is recommended to decrease blood pressure in patients with hypertension. Current medical guidelines also recommend that both patients with hypertension and those with heart failure should decrease their dietary salt intake.

The diets that patients will eat in this study are the DASH/sodium-restricted (DASH/SRD) diet as well as a control diet based on the average reported diet collected using Food Frequency Questionnaires during our pilot study. Patients will be randomized to one diet for three weeks and then crossover to the other diet for three weeks. Patients will then be asked to eat the DASH/sodium-restricted diet on their own at home with dietary support for an additional eight weeks.

In this study, the main goal is to confirm the findings of our earlier study. The investigators would also like to understand how the DASH/SRD changes the function of the heart and blood vessels during exercise and the activity of genes that could be involved in HFPEF.

연구 유형

중재적

등록 (실제)

18

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Michigan
      • Ann Arbor, Michigan, 미국, 48109
        • University of Michigan

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

50년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Symptoms and/or signs of HFPEF in the past 12 months
  • Most recent LVEF ≥ 50% (contrast ventriculography, echocardiography, nuclear scintigraphy)
  • Diastolic dysfunction on previous echocardiogram/catheterization or evidence of abnormal neurohormonal activation (B-type natriuretic peptide (BNP) ≥ 100 pg/ml)
  • History of systemic hypertension
  • Willing to adhere to provided diet

Exclusion Criteria:

  • NYHA Class IV heart failure symptoms
  • Hospitalization for decompensated HF within past one month
  • Uncontrolled hypertension (seated SBP ≥ 180 or DBP ≥ 110) at rest, on current antihypertensive regimen
  • Changes in medical regimen for heart disease or hypertension within past 1 month, except diuretic dose adjustment (within past 1 week)
  • Previous LVEF < 40%
  • Primary exercise limitation due to severe pulmonary disease
  • Uninterpretable echocardiographic windows
  • Worse than moderate mitral or aortic stenosis or insufficiency.
  • Baseline serum potassium level > 5.0 mmol/L or prior history of potassium > 6.0
  • Serum calcium/phosphorus product > 50 at baseline
  • Severe renal insufficiency (current estimated GFR < 30 ml/min)
  • Severe anemia (Hgb < 9 g/dL)
  • Severely uncontrolled diabetes mellitus (Hgb A1C > 10%)
  • Non-hypertension related cause of HFPEF (e.g. amyloidosis, sarcoidosis, constrictive pericardial syndromes, primary hypertrophic or restrictive cardiomyopathy)
  • Primary right ventricular failure
  • Myocardial infarction or unstable angina, including new or worsening anginal syndrome, within the past three months
  • Uncontrolled arrhythmia (including non rate-controlled atrial fibrillation)
  • Terminal illness expected to result in death within six months
  • Psychiatric disorder or dementia with potential to compromise dietary adherence

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: DASH/Sodium-Restricted Diet Intervention
Each patient will eat 3 weeks of the provided DASH/SRD diet for 21 days. The diet is patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants. At enrollment patients will be randomized to the DASH/SRD or Control Diet for 21 days and then cross over to the other for 21 days. Immediately following the provided DASH/SRD and Control Diet, patients will be instructed to adhere to the DASH/SRD for an additional eight weeks with dietary support.
행동: DASH/sodium-restricted diet (DASH/SRD)
Baseline diet will be assessed via Block Food Frequency Questionnaire, and 24-hour urinary sodium, potassium, and 8-isoprostanes will be measured. Subjects will then be assigned to 21 days of the DASH/SRD, with all food and beverages provided. The target sodium content will be 1,500 mg/2,100 kcal, as per recent American Heart Association population recommendations for sodium intake. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the 21 days urinary sodium, potassium, and 8-isoprostanes will again be measured.
다른 이름들:
  • 대시 다이어트
  • 나트륨 제한 식단
  • 저나트륨 식단
  • DASH-나트륨
행동: Control Diet
The Control Diet will be patterned on the information we collected using Food Frequency Questionnaires during our pilot study HUM00025253 (i.e., the dietary patterns reported by previously recruited hypertensive HFPEF patients). The target sodium content will be 3,500 mg per 2,100 kcal and target potassium content for the control diet will be 2,000 mg per 2,100 kcal.
활성 비교기: Control Diet Intervention
Patients will consume 3 weeks of a specially prepared diet that will be patterned on the information we collected using Food Frequency Questionnaires during our pilot study. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants. At enrollment patients will be randomized to the DASH/SRD or Control Diet for 21 days and then cross over to the other for 21 days. Immediately following the provided DASH/SRD and Control Diet, patients will be instructed to adhere to the DASH/SRD for an additional eight weeks with dietary support.
행동: DASH/sodium-restricted diet (DASH/SRD)
Baseline diet will be assessed via Block Food Frequency Questionnaire, and 24-hour urinary sodium, potassium, and 8-isoprostanes will be measured. Subjects will then be assigned to 21 days of the DASH/SRD, with all food and beverages provided. The target sodium content will be 1,500 mg/2,100 kcal, as per recent American Heart Association population recommendations for sodium intake. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the 21 days urinary sodium, potassium, and 8-isoprostanes will again be measured.
다른 이름들:
  • 대시 다이어트
  • 나트륨 제한 식단
  • 저나트륨 식단
  • DASH-나트륨
행동: Control Diet
The Control Diet will be patterned on the information we collected using Food Frequency Questionnaires during our pilot study HUM00025253 (i.e., the dietary patterns reported by previously recruited hypertensive HFPEF patients). The target sodium content will be 3,500 mg per 2,100 kcal and target potassium content for the control diet will be 2,000 mg per 2,100 kcal.
간섭 없음: Healthy Control
Fifteen healthy age-matched and 10 young healthy control patients will be recruited. Age-matched healthy control subjects will undergo testing before and after 3 weeks of eating their habitual diet. Young healthy control subjects will only require 1 study visit with no dietary intervention.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Urinary F2-Isoprostanes
기간: The change from Baseline in Urinary F2-Isoptorstanes at Week 3, Week 6, and Week 14
The change from Baseline in Urinary F2-Isoptorstanes at Week 3, Week 6, and Week 14

2차 결과 측정

결과 측정
측정값 설명
기간
24-hour ambulatory blood pressure (mean and diurnal variation)
기간: The change from Baseline in 24-hour blood pressure at Week 3, Week 6, and Week 14
The change from Baseline in 24-hour blood pressure at Week 3, Week 6, and Week 14
Carotid-femoral pulse wave velocity
기간: The change from Week 3 in Carotid-femoral pulse wave velocity at Week 6, and Week 14
The change from Week 3 in Carotid-femoral pulse wave velocity at Week 6, and Week 14
Six minute walk test distance
기간: The change from Baseline in six minute walk test distance at Week 3, Week 6, and Week 14
The change from Baseline in six minute walk test distance at Week 3, Week 6, and Week 14
Estimated glomerular filtration rate, serum potassium, serum calcium-phosphorus product
기간: The change from Baseline in estimated glomerular filtration rate, serum potassium, serum calcium-phosphorus distance at Week 3, Week 6, and Week 14
The change from Baseline in estimated glomerular filtration rate, serum potassium, serum calcium-phosphorus distance at Week 3, Week 6, and Week 14
Echocardiographic ventricular systolic and diastolic function (resting), ventricular-vascular coupling (resting and during bicycle ergometer exercise)
기간: The change from Week 3 in Echocardiographic ventricular systolic and diastolic function (resting), ventricular-vascular coupling (resting and during bicycle ergometer exercise) at Week 6, and Week 14
The change from Week 3 in Echocardiographic ventricular systolic and diastolic function (resting), ventricular-vascular coupling (resting and during bicycle ergometer exercise) at Week 6, and Week 14
Knowledge, skills and attitudes related to DASH/SRD
기간: Change from the screening visit in knowledge, skills and attitudes related to DASH/SRD to Week 6
Will be assessed using the Dietary Sodium Restriction and the PACE questionnaires
Change from the screening visit in knowledge, skills and attitudes related to DASH/SRD to Week 6
Pro-oxidant and pro-inflammatory gene activation in peripheral mononuclear cells and venous endothelial cells
기간: The change from Baseline in Pro-oxidant and pro-inflammatory gene activation in peripheral mononuclear cells and venous endothelial cells at Week 3, Week 6, and Week 14
The change from Baseline in Pro-oxidant and pro-inflammatory gene activation in peripheral mononuclear cells and venous endothelial cells at Week 3, Week 6, and Week 14

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Michigan

수사관

  • 수석 연구원: Scott L Hummel, MD MS, University of Michigan

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2012년 9월 18일

기본 완료 (실제)

2015년 11월 18일

연구 완료 (실제)

2016년 2월 16일

연구 등록 날짜

최초 제출

2013년 8월 21일

QC 기준을 충족하는 최초 제출

2013년 9월 13일

처음 게시됨 (추정)

2013년 9월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 6월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 6월 4일

마지막으로 확인됨

2018년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • HUM00052649

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

확장기 심부전에 대한 임상 시험

DASH/sodium-restricted diet (DASH/SRD)에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in South Africa

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
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