HypertensionGUARDDNCT02234063
Genetic Testing to Understand and Address Renal Disease Disparities
A study testing Immediate Genetic Testing in people with Hypertension and Chronic Kidney Disease, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Chronic Kidney Disease, Genomics
- What is being tested?
- Immediate Genetic Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,052 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2014to 12 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages18-65
- Self-identifies as Black/African American
- History of hypertension
- Patient at a participating site
Who cannot join
- History of Chronic Kidney Disease
- History of Diabetes
- Pregnant
- Cognitively impaired/unable to provide consent
- Terminally ill
- Planning to leave area of study permanently during the one year study period
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Institute for Family Health
New York, New York, 10006
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Genomic Medicine Pilot for Hypertension and Kidney Disease in Primary Care
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 .
Read the detailed description
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.
- Conditions
- Hypertension, Chronic Kidney Disease, Genomics
- Being tested
- Immediate Genetic Testing
- Keywords
- Hypertension, Chronic Kidney Disease, End Stage Renal Disease, APOL1, Genomics, Genetics, Community-engaged
- Medical subject headings
- Hypertension, Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Genetic TestingOther
Also called Genetic Risk Communication
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Genetic Testing | Experimental | Participants randomized to intervention will receive the APOL1 genetic test upon study enrollment. Receives: Other: Immediate Genetic Testing |
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 12 months
Change in Systolic Blood Pressure
Change in systolic blood pressure at 3 months as compared to baseline
Measured: Baseline and 3 months
Secondary outcomes (3)
Number of Participants With Change in Medication Adherence
Participant surveys (self-report) regarding medication adherence behaviors 3 months after randomization
Measured: 3 months
Number of Patients With Changes in Psychosocial Behaviors
Number of patients with changes in psychosocial behaviors 3 months after randomization
Measured: 3 months
Number of Participants With Attitude Towards Genetic Testing
Patient attitude towards genetic testing 3 months after randomization
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startNov 2014
- Primary completion12 Jan 2018
- Study completion12 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,052 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carol R Horowitz, Icahn School of Medicine at Mount Sinai
- Investigators
- Erwin Bottinger, MD, MPH, Principal investigator, Icahn School of Medicine at Mount SinaiCarol R Horowitz, MD, MPH, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234063
- Sponsor's protocol ID
- GCO 12-1143
- Acronym
- GUARDD
- Status last verified
- Sep 2020
- First submitted
- 4 Sep 2014
- Last updated
- 5 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 35244702
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic Medicine Pilot for Hypertension and Kidney Disease in Primary Care
- ClinicalTrials.gov ID
- NCT02234063
- Acronym / sponsor ID
- GUARDD / GCO 12-1143
- Conditions
- Hypertension, Chronic Kidney Disease, Genomics
- Keywords
- Hypertension, Chronic Kidney Disease, End Stage Renal Disease, APOL1, Genomics, Genetics, Community-engaged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,052 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- 12 Jan 2018 (actual)
- Study completion
- 12 Jan 2018 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Posted 5 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Genetic Testing | Experimental | Other: Immediate Genetic TestingParticipants 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages18-65
- Self-identifies as Black/African American
- History of hypertension
- Patient at a participating site
Key exclusion criteria (6 listed)
- History of Chronic Kidney Disease
- History of Diabetes
- Pregnant
- Cognitively impaired/unable to provide consent
- Terminally ill
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate Genetic TestingAlso: Genetic Risk CommunicationParticipants 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. | Other | Immediate Genetic Testing |
Primary outcome
Number of Participants With Urine Protein Excretion
Time frame: Baseline and 12 months
Number of participants with urine protein excretion in urine tests to assess kidney function at 12 months as compared to baseline
Change in Systolic Blood Pressure
Time frame: Baseline and 3 months
Change in systolic blood pressure at 3 months as compared to baseline
3 secondary outcomes
Number of Participants With Change in Medication Adherence
Time frame: 3 months
Number of Patients With Changes in Psychosocial Behaviors
Time frame: 3 months
Number of Participants With Attitude Towards Genetic Testing
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35244702Nadkarni 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.
- Implementing GeNomics In PracTicE (IGNITE) Network WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erwin Bottinger, MD, MPH principal investigator
Icahn School of Medicine at Mount Sinai
Carol R Horowitz, MD, MPH principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Genetic Testing in people with Hypertension and Chronic Kidney Disease, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Urine Protein Excretion (time frame: Baseline and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02234063, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.