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In this genomic medicine implementation pilot project, the investigators aim to conduct a randomized trial in a network of community health centers and primary care facilities to study processes, effects and challenges of incorporating information for apolipoprotein L1 (APOL1)-attributable genetic risk for end stage kidney disease in patients of African ancestry with hypertension .
CKD is most commonly associated with diabetes (40%) and hypertension (28%), and affects 26 million American adults. African ancestry populations with hypertension (HTN) have 2- to 3-fold higher risk of developing CKD, and a 5-fold increased risk to progress to end stage renal disease (ESRD) when compared with whites. HTN is a risk factor for progression of CKD and for increased cardiovascular risk with CKD. Thus targeting blood pressure control as a modifiable risk factor may both reduce CVD in people with CKD and reduce progression of CKD to end stage disease. Recent discoveries demonstrate that testable alleles of the APOL1 locus on chromosome 22 have a major effect on and explain almost all of the excess risk for hypertension-associated CKD and its progression to ESRD in African ancestry populations.
We will use community-engaged approaches to enroll patients of African Ancestry with HTN from a network of community health centers and primary care facilities in Harlem and the Bronx and randomize them on a 7 to 1 ratio to receive APOL1 genetic testing and EMR-enabled provider clinical decision support incorporating APOL1 genomic risk information.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Genetic Testing | Experimental | Participants randomized to intervention will receive the APOL1 genetic test upon study enrollment. |
|
| Control- Delayed Testing | No Intervention | Participants randomized to control will not receive the APOL1 genetic test upon study enrollment. They will be offered the option to take the test during their final follow-up study visit (12 months post enrollment). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate Genetic Testing | Other | Participants will receive the APOL1 genetic test. Trained research staff will meet with participants to communicate results and lifetime ESRD risk attributable to variations in the APOL1 gene. Primary care providers will receive APOL1 genetic risk information via a best practice alert in the participant's EMR upon commencement of a patient encounter and through results filed in the participant's genetics results section of their EMR. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Urine Protein Excretion | Number of participants with urine protein excretion in urine tests to assess kidney function at 12 months as compared to baseline | Baseline and 12 months |
| Change in Systolic Blood Pressure | Change in systolic blood pressure at 3 months as compared to baseline | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Change in Medication Adherence | Participant surveys (self-report) regarding medication adherence behaviors 3 months after randomization | 3 months |
| Number of Patients With Changes in Psychosocial Behaviors |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erwin Bottinger, MD, MPH | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Carol R Horowitz, MD, MPH | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Family Health | New York | New York | 10006 | United States | ||
| Icahn School of Medicine at Mount Sinai |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35244702 | Derived | Nadkarni GN, Fei K, Ramos MA, Hauser D, Bagiella E, Ellis SB, Sanderson S, Scott SA, Sabin T, Madden E, Cooper R, Pollak M, Calman N, Bottinger EP, Horowitz CR. Effects of Testing and Disclosing Ancestry-Specific Genetic Risk for Kidney Failure on Patients and Health Care Professionals: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e221048. doi: 10.1001/jamanetworkopen.2022.1048. |
| Label | URL |
|---|---|
| Implementing GeNomics In PracTicE (IGNITE) Network Website | View source |
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Patients were recruited from 15 academic, community and safety-net practices in New York City. 2052 participants were enrolled. however 2 participants were not randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Genetic Testing | Participants randomized to intervention will receive the APOL1 genetic test immediately upon study enrollment. |
| FG001 | Control- Delayed Testing | Participants randomized to control will not receive the APOL1 genetic test upon study enrollment. They will be offered the option to take the test during their final follow-up study visit (12 months post enrollment). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control- Delayed Testing | Participants randomized to control will not receive the APOL1 genetic test upon study enrollment. They will be offered the option to take the test during their final follow-up study visit (12 months post enrollment). |
| BG001 | Immediate Genetic Testing |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Number of Participants With Urine Protein Excretion | Number of participants with urine protein excretion in urine tests to assess kidney function at 12 months as compared to baseline | Posted | Count of Participants | Participants | Baseline and 12 months |
|
3 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 | Control- Delayed Testing | Participants randomized to control did not receive the APOL1 genetic test upon study enrollment. They were offered the option to take the test during their final follow-up study visit (12 months post enrollment). |
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Primary analysis was conducted on the Genotype level and not on the randomization level.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carol R. Horowitz | Icahn School of Medicine at Mount Sinai | 212-659-9564 | carol.horowitz@mssm.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 | Mar 16, 2016 | Jul 31, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D051436 | Renal Insufficiency, Chronic |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
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|
|
Number of patients with changes in psychosocial behaviors 3 months after randomization
| 3 months |
| Number of Participants With Attitude Towards Genetic Testing | Patient attitude towards genetic testing 3 months after randomization | 3 months |
| New York |
| New York |
| 10029 |
| United States |
Participants randomized to intervention will receive the APOL1 genetic test immediately upon study enrollment. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Household income <$30,000/year | Results available for those participants who chose to provide data for this measure. | Count of Participants | Participants |
|
| Education more than some college | Results available for those participants who chose to provide data for this measure. | Count of Participants | Participants |
|
| Married/Partner | Results available for those participants who chose to provide data for this measure. | Count of Participants | Participants |
|
| Type of Insurance | Results available for those participants who chose to provide data for this measure. | Count of Participants | Participants |
|
| Charlson Comorbidity Index | Charlson Comorbidity Index (CCI) predicts 10-year survival in patients with multiple comorbidities. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use. | Count of Participants | Participants |
|
| Baseline mean Systolic Blood Pressure | Results available for those participants who chose to provide data for this measure. | Mean | Standard Deviation | mmHg |
|
| Body mass index | Results available for those participants who chose to provide data for this measure. | Mean | Standard Deviation | kg/m^2 |
|
| Number of Participants with High health literacy | Number of participants who responded with (5) very much confident filling out medical forms. Health literacy was assessed at baseline using a single item - "How confident are you filling out medical forms by yourself?" Responses were recorded using a five-point Likert scale of: Not at all confident (1), A little bit confident (2), Somewhat confident (3), Quite a bit confident (4), Very much confident (5). | Results available for those participants who chose to provide data for this measure | Count of Participants | Participants |
|
| Excellent/Very good self-reported Health | Count of Participants | Participants |
|
| OG002 | Immediate Genetic Testing for APOL1 Positive | Participants with high-risk APOL1 alleles (APOL1 positives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment. |
|
|
| Primary | Change in Systolic Blood Pressure | Change in systolic blood pressure at 3 months as compared to baseline | Results available for those participants who returned for 3 month visit and had both timepoint data. | Posted | Mean | Standard Deviation | mmHg | Baseline and 3 months |
|
|
|
| Secondary | Number of Participants With Change in Medication Adherence | Participant surveys (self-report) regarding medication adherence behaviors 3 months after randomization | Survey only for participants who received genetic testing. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Number of Patients With Changes in Psychosocial Behaviors | Number of patients with changes in psychosocial behaviors 3 months after randomization | Survey only for participants who received genetic testing. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Number of Participants With Attitude Towards Genetic Testing | Patient attitude towards genetic testing 3 months after randomization | Survey only for participants who received genetic testing. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 255 |
| 0 |
| 255 |
| 0 |
| 255 |
| EG001 | Immediate Genetic Testing for APOL1 Negative | Participants with low-risk APOL1 alleles (APOL1 negatives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment. | 0 | 1,561 | 0 | 1,561 | 0 | 1,561 |
| EG002 | Immediate Genetic Testing for APOL1 Positive | Participants with high-risk APOL1 alleles (APOL1 positives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment. | 0 | 234 | 0 | 234 | 0 | 234 |
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| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| 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 |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Would get tested again |
|