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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01MD010550-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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This Five, Plus Nuts and Beans for Kidneys Study is a single center, randomized controlled trial with 2 parallel arms testing the hypothesis that delivery of nutritional advice to adopt a Dietary Approaches to Stop Hypertension (DASH)-like diet and $30/week worth of fruits, vegetables, nuts and beans tailored to personal choices and availability in neighborhood stores, will reduce kidney damage in African Americans with hypertension and chronic kidney disease.
This study will test the effectiveness of dietary advice delivered by a study coach and assistance with weekly online ordering of $30/week worth of potassium rich foods delivered by a local grocer to a community location for reducing urinary albumin excretion among African Americans with hypertension and chronic kidney disease. Participants will be recruited from primary care clinics in Baltimore, MD.
150 African American adults diagnosed with hypertension and with mild/moderate chronic kidney disease based on the presence of albuminuria will be randomly assigned to one of two arms for 12 months. There are 2 phases of the study. In Phase 1 (months 1-4), one study arm will consist of minimal guidance from the study team and a weekly allowance of $30 dollars to purchase food and drinks of their choosing from a local grocer. During Phase 1, the second arm of the study will receive dietary guidance from the study coach and assistance with ordering and purchasing $30/week worth of high potassium foods from the same local grocer. In Phase 2 (months 5-12) neither study arm will receive a food allowance, however the second arm will receive telephonic visits and dietary advice from the study coach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-Shopping DASH group (S-DASH) | Active Comparator | The Self-Shopping DASH group will receive printed patient-centered materials on the DASH diet and chronic kidney disease. Participants will also receive $30/week allowance for the purchase of food and drinks of their choosing from a local grocer (Klein's ShopRite stores of Maryland) during the first four months. During the remainder of the study (months 5-12), the participants in this group will be asked to continue to follow the dietary advice provided but will not receive the food allowance. |
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| Coaching DASH group (C-DASH) | Experimental | The C-DASH group intervention will be a patient-tailored program, delivered by a study coach that is trained by a dietitian, which emphasizes key self-management behaviors - diet and self-monitoring. This group will receive advice from the study coach and purchase $30 worth of fresh fruits, vegetables, nuts and beans that are high in potassium on a weekly basis for the first four months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coaching DASH group (C-DASH) | Behavioral | Participants assigned to the C-DASH diet advice group will be provided $30/week worth of fruits, vegetables, nuts and beans ordered through the study coach and delivered to a community location to reach a certain goal of potassium intake (months 0-4). During phase 2 of the study (months 5-12), a study coach will continue telephonic contact with the participants to set goals for following a DASH-like diet without the weekly food allowance. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Urinary Albumin Excretion From Baseline to 4 Months | Urine samples will be collected for ACR (albumin-to-creatinine ratio). | Baseline, 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure From Baseline to 4 Months | Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl | Baseline,4 months |
| Change in Systolic Blood Pressure From Baseline to 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Urinary Albumin Excretion From Baseline to 1 Month | Urine samples will be collected for ACR (albumin-to-creatinine ratio). | Baseline, 1 month |
| Change in Systolic Blood Pressure From Baseline to 1 Month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deidra Crews, MD, ScM | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Baltimore Medical Campus | Baltimore | Maryland | 21202 | United States |
Plan to share the Statistical Analysis Plan and Study Protocol.
Data will be available after one year after final data collection.
Will release de-identified information per request via Johns Hopkins agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Coaching DASH Group (C-DASH) | The C-DASH group intervention will be a patient-tailored program, delivered by a study coach that is trained by a dietitian, which emphasizes key self-management behaviors - diet and self-monitoring. This group will receive advice from the study coach and purchase $30 worth of fresh fruits, vegetables, nuts and beans that are high in potassium on a weekly basis for the first four months. Coaching DASH group (C-DASH): Participants assigned to the C-DASH diet advice group will be provided $30/week worth of fruits, vegetables, nuts and beans ordered through the study coach and delivered to a community location to reach a certain goal of potassium intake (months 0-4). During phase 2 of the study (months 5-12), a study coach will continue telephonic contact with the participants to set goals for following a DASH-like diet without the weekly food allowance. |
| FG001 | Self-Shopping DASH Group (S-DASH) | The Self-Shopping DASH group will receive printed patient-centered materials on the DASH diet and chronic kidney disease. Participants will also receive $30/week allowance for the purchase of food and drinks of their choosing from a local grocer (Klein's ShopRite stores of Maryland) during the first four months. During the remainder of the study (months 5-12), the participants in this group will be asked to continue to follow the dietary advice provided but will not receive the food allowance. Self-Shopping DASH group (S-DASH): Participants will be given a brochure containing information about the DASH diet which will be reviewed with a study team member. In months 1-4, participants will receive a gift card equivalent to a weekly allowance of $30 to Klein's ShopRite stores of Maryland for purchases of food and beverages of their choice. During phase two (months 5-12), they will be asked to continue following a DASH-like diet but will not receive a gift card for purchases. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: 4-month Intervention Period |
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| Phase 2: 12-month Follow-up Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Coaching DASH Group (C-DASH) | The C-DASH group intervention will be a patient-tailored program, delivered by a study coach that is trained by a dietitian, which emphasizes key self-management behaviors - diet and self-monitoring. This group will receive advice from the study coach and purchase $30 worth of fresh fruits, vegetables, nuts and beans that are high in potassium on a weekly basis for the first four months. Coaching DASH group (C-DASH): Participants assigned to the C-DASH diet advice group will be provided $30/week worth of fruits, vegetables, nuts and beans ordered through the study coach and delivered to a community location to reach a certain goal of potassium intake (months 0-4). During phase 2 of the study (months 5-12), a study coach will continue telephonic contact with the participants to set goals for following a DASH-like diet without the weekly food allowance. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Urinary Albumin Excretion From Baseline to 4 Months | Urine samples will be collected for ACR (albumin-to-creatinine ratio). | For C-DASH, 3 participants were excluded from analysis: 1 withdrew from the study and 2 were lost to follow-up. | Posted | Least Squares Mean | Standard Error | mg/g | Baseline, 4 months |
|
The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months
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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 | Coaching DASH Group (C-DASH) | The C-DASH group intervention will be a patient-tailored program, delivered by a study coach that is trained by a dietitian, which emphasizes key self-management behaviors - diet and self-monitoring. This group will receive advice from the study coach and purchase $30 worth of fresh fruits, vegetables, nuts and beans that are high in potassium on a weekly basis for the first four months. Coaching DASH group (C-DASH): Participants assigned to the C-DASH diet advice group will be provided $30/week worth of fruits, vegetables, nuts and beans ordered through the study coach and delivered to a community location to reach a certain goal of potassium intake (months 0-4). During phase 2 of the study (months 5-12), a study coach will continue telephonic contact with the participants to set goals for following a DASH-like diet without the weekly food allowance. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertensive Urgency | Vascular disorders | Systematic Assessment | BP >= 160/100 |
The COVID-19 pandemic restricted in-person research activities for ~6 months, which impacted trial conduct in two ways: (1) 8 of the participants randomized at the onset of the pandemic did not return when restrictions on in person research were lifted. They were excluded from the final sample size. (2) Upon resuming in-person activities, the protocol was modified to Phase 1 only for the 33 participants who were randomized in 2021, so that the trial could be completed within the funding period.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deidra C. Crews, MD, ScM | Johns Hopkins University School of Medicine | 410-502-0518 | dcrews1@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 24, 2020 | Jul 15, 2020 | Prot_SAP_004.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006973 | Hypertension |
| D000419 | Albuminuria |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Single center, randomized controlled trial with two parallel arms.
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|
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| Self-Shopping DASH group (S-DASH) | Behavioral | Participants will be given a brochure containing information about the DASH diet which will be reviewed with a study team member. In months 1-4, participants will receive a gift card equivalent to a weekly allowance of $30 to Klein's ShopRite stores of Maryland for purchases of food and beverages of their choice. During phase two (months 5-12), they will be asked to continue following a DASH-like diet but will not receive a gift card for purchases. |
|
|
Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
| Baseline, end of study (approximately 12 months) |
| Change in Urinary Albumin Excretion From Baseline to 12 Months | Urine samples will be collected for ACR (albumin-to-creatinine ratio). | Baseline, end of study (approximately 12 months) |
Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
| Baseline, 1 month |
| NOT COMPLETED |
|
|
| BG001 | Self-Shopping DASH Group (S-DASH) | The Self-Shopping DASH group will receive printed patient-centered materials on the DASH diet and chronic kidney disease. Participants will also receive $30/week allowance for the purchase of food and drinks of their choosing from a local grocer (Klein's ShopRite stores of Maryland) during the first four months. During the remainder of the study (months 5-12), the participants in this group will be asked to continue to follow the dietary advice provided but will not receive the food allowance. Self-Shopping DASH group (S-DASH): Participants will be given a brochure containing information about the DASH diet which will be reviewed with a study team member. In months 1-4, participants will receive a gift card equivalent to a weekly allowance of $30 to Klein's ShopRite stores of Maryland for purchases of food and beverages of their choice. During phase two (months 5-12), they will be asked to continue following a DASH-like diet but will not receive a gift card for purchases. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Baseline Urinary albumin-to-creatine (ACR) | Mean | Inter-Quartile Range | mg/g |
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| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
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| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
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| Diabetes (Self-report) | Count of Participants | Participants |
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| Urinary albumin-to-creatine ratio category | Count of Participants | Participants |
|
| OG001 | Self-Shopping DASH Group (S-DASH) | The Self-Shopping DASH group will receive printed patient-centered materials on the DASH diet and chronic kidney disease. Participants will also receive $30/week allowance for the purchase of food and drinks of their choosing from a local grocer (Klein's ShopRite stores of Maryland) during the first four months. During the remainder of the study (months 5-12), the participants in this group will be asked to continue to follow the dietary advice provided but will not receive the food allowance. Self-Shopping DASH group (S-DASH): Participants will be given a brochure containing information about the DASH diet which will be reviewed with a study team member. In months 1-4, participants will receive a gift card equivalent to a weekly allowance of $30 to Klein's ShopRite stores of Maryland for purchases of food and beverages of their choice. During phase two (months 5-12), they will be asked to continue following a DASH-like diet but will not receive a gift card for purchases. |
|
|
|
| Secondary | Change in Systolic Blood Pressure From Baseline to 4 Months | Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl | For C-DASH, 4 participants were excluded from analysis: 1 withdrew from the study, 2 were lost to follow-up, and 1 was due to measurement error. For S-DASH, 5 participants were excluded: 4 were due to measurement error, and 1 due to an out-of-range baseline reading. | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline,4 months |
|
|
|
|
| Secondary | Change in Systolic Blood Pressure From Baseline to 12 Months | Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl | For C-DASH, 9 participants were excluded from analysis: 1 withdrew from Phase 2 of the study, 3 were lost to follow-up, 1 due to measurement error, 1 moved out of state, and 3 were restricted from providing in-person data collection due to the COVID-19 pandemic. For S-DASH, 12 participants were excluded: 4 were lost to follow-up, 5 due to measurement error, and 3 were restricted from in-person data collection due to the pandemic. | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline, end of study (approximately 12 months) |
|
|
|
|
| Secondary | Change in Urinary Albumin Excretion From Baseline to 12 Months | Urine samples will be collected for ACR (albumin-to-creatinine ratio). | For C-DASH, 7 participants were excluded from analysis: 1 withdrew during Phase 2 of the study, 2 were lost to follow-up, and 4 were restricted from providing in-person data collection due to the COVID-19 pandemic. For S-DASH, 8 participants were excluded: 3 were lost to follow-up, 1 sample was lost due to lab error, and 4 were restricted due to the pandemic. | Posted | Least Squares Mean | Standard Error | mg/g | Baseline, end of study (approximately 12 months) |
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|
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| Other Pre-specified | Change in Urinary Albumin Excretion From Baseline to 1 Month | Urine samples will be collected for ACR (albumin-to-creatinine ratio). | For C-DASH, 3 participants were excluded from analysis: 1 withdrew from the study, and 2 were lost to follow-up. For S-DASH, 1 participant was excluded from analysis due to an invalid urine sample. | Posted | Least Squares Mean | Standard Error | mg/g | Baseline, 1 month |
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|
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| Other Pre-specified | Change in Systolic Blood Pressure From Baseline to 1 Month | Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl | For C-DASH, 7 participants were excluded from analysis: 1 withdrew from the study, 2 were lost to follow-up, and 4 were due to measurement error. For S-DASH, 4 participants were excluded: 3 were due to measurement error, and 1 due to an out-of-range at baseline reading. | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline, 1 month |
|
|
|
|
| 0 |
| 70 |
| 7 |
| 70 |
| 10 |
| 70 |
| EG001 | Self-Shopping DASH Group (S-DASH) | The Self-Shopping DASH group will receive printed patient-centered materials on the DASH diet and chronic kidney disease. Participants will also receive $30/week allowance for the purchase of food and drinks of their choosing from a local grocer (Klein's ShopRite stores of Maryland) during the first four months. During the remainder of the study (months 5-12), the participants in this group will be asked to continue to follow the dietary advice provided but will not receive the food allowance. Self-Shopping DASH group (S-DASH): Participants will be given a brochure containing information about the DASH diet which will be reviewed with a study team member. In months 1-4, participants will receive a gift card equivalent to a weekly allowance of $30 to Klein's ShopRite stores of Maryland for purchases of food and beverages of their choice. During phase two (months 5-12), they will be asked to continue following a DASH-like diet but will not receive a gift card for purchases. | 0 | 72 | 7 | 72 | 16 | 72 |
| Cardiac Catheterization | Surgical and medical procedures | Systematic Assessment |
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| Angioneurotic edema | Injury, poisoning and procedural complications | Systematic Assessment | due to lisinopril |
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| Acute kidney failure | Renal and urinary disorders | Systematic Assessment | possibly due to Lisinopril |
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| Cerebral infarction, unspecified | Vascular disorders | Systematic Assessment |
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| Chronic pancreatitis | Gastrointestinal disorders | Systematic Assessment |
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| COVID-19 | Infections and infestations | Systematic Assessment |
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| Diabetes mellitus with ketoacidosis | Endocrine disorders | Systematic Assessment |
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| Mechanical complication of ventricular intracranial (communicating) shunt | Nervous system disorders | Systematic Assessment |
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| Moderate persistent asthma with (acute) exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Motor Vehicle Accident | Injury, poisoning and procedural complications | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
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| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
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| Angina pectoris | Vascular disorders | Systematic Assessment |
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| Aortic aneurysm and dissection | Vascular disorders | Systematic Assessment |
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| Cellulitis | Infections and infestations | Systematic Assessment |
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| Chest pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Chest pain, unspecified | Gastrointestinal disorders | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Gastrointestinal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Non-ST elevation myocardial infarction | Vascular disorders | Systematic Assessment |
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| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Thrombophilia | Blood and lymphatic system disorders | Systematic Assessment |
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| Thrombotic microangiopathy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Type 2 Subsequent non-ST elevation myocardial infarction | Vascular disorders | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011507 | Proteinuria |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |