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Heart failure with preserved systolic function (HF-PSF, or 'diastolic heart failure') accounts for half of hospitalizations for heart failure in patients over the age of 65. Most HF-PSF patients have systemic hypertension (HTN), and characteristic HTN-induced cardiovascular changes contribute to HF-PSF. However, it is unclear why most patients with HTN never develop HF-PSF or which specific aspects of HTN predispose to HF-PSF.
In the Dahl S rat, the primary animal model of HF-PSF, high dietary sodium intake suppresses the systemic renin-angiotensin-aldosterone system, but upregulates renal and cardiac renin-angiotensin-aldosterone system by inducing oxidative stress. In humans, the magnitude of blood pressure response to sodium ingestion and depletion can categorize subjects as "salt-resistant" and "salt-sensitive." Human salt sensitivity is associated with structural and loading conditions that increase the risk for HF-PSF, including HTN, ventricular hypertrophy and diastolic dysfunction, arterial stiffening, and increased plasma volume. High dietary sodium intake induces oxidative stress in salt-sensitive humans. In humans with HTN and normal ventricular systolic function that do not have heart failure, increased oxidative stress predicts impaired exercise capacity, ventricular hypertrophy, diastolic dysfunction, arterial stiffening, and vascular endothelial dysfunction. The investigators have proposed that "salt sensitivity" and the accompanying oxidative stress on the typical high-sodium Western diet may contribute to the initiation and progression of HF-PSF.
In patients with HF-PSF, the investigators will relate dietary changes to biochemical and cardiovascular functional measures. The investigators will study subjects on ad-lib diet and and following three weeks of rigorous dietary modification with the Dietary Approaches to Stop Hypertension (DASH)/sodium-restricted diet (SRD). This diet is richer in natural antioxidants and lower in sodium than the usual American diet. The DASH/SRD is recommended to lower blood pressure in patients with HTN, and is particularly effective in elderly, obese, and salt-sensitive hypertensives. Dietary sodium restriction is recommended for all HF patients including those with HF-PSF. The investigators hypothesize that the DASH/SRD will have favorable effects on oxidative stress, ventricular and vascular function, and blood pressure control in patients with hypertensive HF-PSF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary intervention | Experimental | Diet patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet includes higher quantities of fresh fruits and vegetables, whole grain products, and low-fat dairy products than the standard American diet. The target sodium content is 50 mmol per 2100 kcal, and the caloric content is intended to maintain body weight. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DASH/sodium-restricted diet (SRD) | Behavioral | 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. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the study urinary sodium, potassium, and 8-isoprostanes will again be measured. |
| Measure | Description | Time Frame |
|---|---|---|
| Brachial Artery Flow-mediated Dilation (FMD) | Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation |
| Measure | Description | Time Frame |
|---|---|---|
| Mean 24-hour Systolic Blood Pressure | Change in 24-hour systolic blood pressure | Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation |
| Diurnal Variation in Ambulatory Blood Pressure |
| Measure | Description | Time Frame |
|---|---|---|
| EndoPAT Arterial Endothelial Function | Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation | |
| Estimated Glomerular Filtration Rate, Serum Potassium, Serum Calcium-phosphorus Product | Safety measures to determine adverse effects of the provided DASH diet home-delivered meals |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott L Hummel, MD MS | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16855265 | Background | Owan TE, Hodge DO, Herges RM, Jacobsen SJ, Roger VL, Redfield MM. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006 Jul 20;355(3):251-9. doi: 10.1056/NEJMoa052256. | |
| 12517230 | Background | Redfield MM, Jacobsen SJ, Burnett JC Jr, Mahoney DW, Bailey KR, Rodeheffer RJ. Burden of systolic and diastolic ventricular dysfunction in the community: appreciating the scope of the heart failure epidemic. JAMA. 2003 Jan 8;289(2):194-202. doi: 10.1001/jama.289.2.194. |
| Label | URL |
|---|---|
| Hypertension publication from this study | View source |
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22 patients screened, 14 enrolled
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| ID | Title | Description |
|---|---|---|
| FG000 | Dietary Intervention | Diet patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet includes higher quantities of fresh fruits and vegetables, whole grain products, and low-fat dairy products than the standard American diet. The target sodium content is 50 mmol per 2100 kcal, and the caloric content is intended to maintain body weight. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants. DASH/sodium-restricted diet (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. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the study urinary sodium, potassium, and 8-isoprostanes will again be measured. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dietary Intervention | Diet patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet includes higher quantities of fresh fruits and vegetables, whole grain products, and low-fat dairy products than the standard American diet. The target sodium content is 50 mmol per 2100 kcal, and the caloric content is intended to maintain body weight. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants. DASH/sodium-restricted diet (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. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the study urinary sodium, potassium, and 8-isoprostanes will again be measured. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Brachial Artery Flow-mediated Dilation (FMD) | Posted | Mean | Standard Deviation | % dilation | Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation |
|
25 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dietary Intervention | Diet patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet includes higher quantities of fresh fruits and vegetables, whole grain products, and low-fat dairy products than the standard American diet. The target sodium content is 50 mmol per 2100 kcal, and the caloric content is intended to maintain body weight. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants. DASH/sodium-restricted diet (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. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the study urinary sodium, potassium, and 8-isoprostanes will again be measured. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment | At day 5 safety visit 1 subject had serum potassium 5.9, an expected potential adverse event in this protocol. There were no associated symptoms or sequelae, and the patient was withdrawn form the study diet as per protocol. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Scott Hummel | University of Michigan | 734-998-7991 | scothumm@med.umich.edu |
Not provided
| ID | Term |
|---|---|
| D054144 | Heart Failure, Diastolic |
| D006973 | Hypertension |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000073601 | Dietary Approaches To Stop Hypertension |
| D004039 | Diet, Sodium-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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|
|
Number of participants with non-dipping of nocturnal blood pressure - nighttime-to-daytime systolic BP ratio of >= 0.9
| Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation |
| Aortic Augmentation Index | Aortic augmentation index is the ratio of the augmentation pressure to the central pulse pressure, expressed as a percentage. Both parameters are obtained via mathematical transformation of the radial pulse wave. The augmentation pressure represents the contribution of reflected waves to the pulse pressure. The central pulse pressure is the ratio between maximum aortic systolic pressure and minimum aortic diastolic pressure. A higher aortic augmentation index and central pulse pressure reflect increased arterial stiffness. Increased arterial stiffness is associated with an increased long-term risk of cardiovascular disease. | Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation |
| Carotid-femoral Pulse Wave Velocity | Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation |
| Ventricular Diastolic Function | Lateral mitral annulus E/e' ratio | Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation |
| Six Minute Walk Test Distance | Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation |
| Urinary 8-isoprostanes | Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation |
| Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation |
| 16585423 | Background | Klotz S, Hay I, Zhang G, Maurer M, Wang J, Burkhoff D. Development of heart failure in chronic hypertensive Dahl rats: focus on heart failure with preserved ejection fraction. Hypertension. 2006 May;47(5):901-11. doi: 10.1161/01.HYP.0000215579.81408.8e. Epub 2006 Apr 3. |
| 16432053 | Background | Laffer CL, Bolterman RJ, Romero JC, Elijovich F. Effect of salt on isoprostanes in salt-sensitive essential hypertension. Hypertension. 2006 Mar;47(3):434-40. doi: 10.1161/01.HYP.0000202480.06735.82. Epub 2006 Jan 23. |
| 17003543 | Background | Dekleva M, Celic V, Kostic N, Pencic B, Ivanovic AM, Caparevic Z. Left ventricular diastolic dysfunction is related to oxidative stress and exercise capacity in hypertensive patients with preserved systolic function. Cardiology. 2007;108(1):62-70. doi: 10.1159/000095883. Epub 2006 Sep 25. |
| 16247215 | Background | Yugar-Toledo JC, Bonalume Tacito LH, Ferreira-Melo SE, Sousa W, Consolin-Colombo F, Irigoyen MC, Franchini K, Coelho OR, Moreno H Jr. Low-renin (volume dependent) mild-hypertensive patients have impaired flow-mediated and glyceryl-trinitrate stimulated vascular reactivity. Circ J. 2005 Nov;69(11):1380-5. doi: 10.1253/circj.69.1380. |
| 11136953 | Background | Sacks FM, Svetkey LP, Vollmer WM, Appel LJ, Bray GA, Harsha D, Obarzanek E, Conlin PR, Miller ER 3rd, Simons-Morton DG, Karanja N, Lin PH; DASH-Sodium Collaborative Research Group. Effects on blood pressure of reduced dietary sodium and the Dietary Approaches to Stop Hypertension (DASH) diet. DASH-Sodium Collaborative Research Group. N Engl J Med. 2001 Jan 4;344(1):3-10. doi: 10.1056/NEJM200101043440101. |
| 17428822 | Background | Paulus WJ, Tschope C, Sanderson JE, Rusconi C, Flachskampf FA, Rademakers FE, Marino P, Smiseth OA, De Keulenaer G, Leite-Moreira AF, Borbely A, Edes I, Handoko ML, Heymans S, Pezzali N, Pieske B, Dickstein K, Fraser AG, Brutsaert DL. How to diagnose diastolic heart failure: a consensus statement on the diagnosis of heart failure with normal left ventricular ejection fraction by the Heart Failure and Echocardiography Associations of the European Society of Cardiology. Eur Heart J. 2007 Oct;28(20):2539-50. doi: 10.1093/eurheartj/ehm037. Epub 2007 Apr 11. |
| 23985432 | Result | Hummel SL, Seymour EM, Brook RD, Sheth SS, Ghosh E, Zhu S, Weder AB, Kovacs SJ, Kolias TJ. Low-sodium DASH diet improves diastolic function and ventricular-arterial coupling in hypertensive heart failure with preserved ejection fraction. Circ Heart Fail. 2013 Nov;6(6):1165-71. doi: 10.1161/CIRCHEARTFAILURE.113.000481. Epub 2013 Aug 28. |
| 23033371 | Result | Hummel SL, Seymour EM, Brook RD, Kolias TJ, Sheth SS, Rosenblum HR, Wells JM, Weder AB. Low-sodium dietary approaches to stop hypertension diet reduces blood pressure, arterial stiffness, and oxidative stress in hypertensive heart failure with preserved ejection fraction. Hypertension. 2012 Nov;60(5):1200-6. doi: 10.1161/HYPERTENSIONAHA.112.202705. Epub 2012 Oct 1. |
| 26497755 | Result | Mathew AV, Seymour EM, Byun J, Pennathur S, Hummel SL. Altered Metabolic Profile With Sodium-Restricted Dietary Approaches to Stop Hypertension Diet in Hypertensive Heart Failure With Preserved Ejection Fraction. J Card Fail. 2015 Dec;21(12):963-7. doi: 10.1016/j.cardfail.2015.10.003. Epub 2015 Oct 20. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Hypertension | Count of Participants | Participants |
|
| Participants with Chronic Kidney Disease | Count of Participants | Participants |
|
| Coronary Artery Disease | Count of Participants | Participants |
|
| Participants wtih Diabetes Mellitus | Count of Participants | Participants |
|
| Participants wtih Anemia | Count of Participants | Participants |
|
| New York Heart Assocation Classification | NYHA class: I No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). II Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea III Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. IV Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. | Count of Participants | Participants |
|
| Participants with prior hospitalization due to heart failure | Count of Participants | Participants |
|
| Participants on chronic loop diuretics | Count of Participants | Participants |
|
| Participants on 3 or more antihypertensive medications | Count of Participants | Participants |
|
| OG001 | Post-dietary Intervention |
|
|
|
| Secondary | Mean 24-hour Systolic Blood Pressure | Change in 24-hour systolic blood pressure | Posted | Mean | Standard Deviation | mm Hg | Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation |
|
|
|
|
| Secondary | Diurnal Variation in Ambulatory Blood Pressure | Number of participants with non-dipping of nocturnal blood pressure - nighttime-to-daytime systolic BP ratio of >= 0.9 | Posted | Count of Participants | Participants | Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation |
|
|
|
| Secondary | Aortic Augmentation Index | Aortic augmentation index is the ratio of the augmentation pressure to the central pulse pressure, expressed as a percentage. Both parameters are obtained via mathematical transformation of the radial pulse wave. The augmentation pressure represents the contribution of reflected waves to the pulse pressure. The central pulse pressure is the ratio between maximum aortic systolic pressure and minimum aortic diastolic pressure. A higher aortic augmentation index and central pulse pressure reflect increased arterial stiffness. Increased arterial stiffness is associated with an increased long-term risk of cardiovascular disease. | Posted | Mean | Standard Deviation | percentage | Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation |
|
|
|
| Secondary | Carotid-femoral Pulse Wave Velocity | Posted | Mean | Standard Deviation | m/s | Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation |
|
|
|
| Secondary | Ventricular Diastolic Function | Lateral mitral annulus E/e' ratio | Posted | Mean | Standard Deviation | ratio | Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation |
|
|
|
| Secondary | Six Minute Walk Test Distance | Posted | Mean | Standard Deviation | meters | Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation |
|
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|
|
| Secondary | Urinary 8-isoprostanes | Posted | Mean | Standard Deviation | mmol F2-iso/mmol Cr | Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation |
|
|
|
|
| Other Pre-specified | EndoPAT Arterial Endothelial Function | Not Posted | Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation | Participants |
| Other Pre-specified | Estimated Glomerular Filtration Rate, Serum Potassium, Serum Calcium-phosphorus Product | Safety measures to determine adverse effects of the provided DASH diet home-delivered meals | Not Posted | Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation | Participants |
| 0 |
| 14 |
| 1 |
| 14 |
|
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| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |