Healthy SubjectsPhase 1NCT02871687
Effect of Statin Use on Aldosterone Secretion
A Phase 1 study testing Simvastatin and Pravastatin in people with Healthy Subjects, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of this research protocol is to determine if the same effects are observed in vivo in humans through a randomized controlled study. Data regarding a novel mechanism of the widely used statin class of medications on the mineralocorticoid pathway would likely have significant clinical implications on the… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Simvastatin and Pravastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Mar 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Blood pressure <140/90 mmHg and >90/50 mmHg
- Body mass index 19-40 kg/m2
- Normal screening laboratory values for:
- Serum sodium, potassium, glucose, liver enzymes ii. GFR (>60 mL/min/1.73m2) iii. A1c iv. TSH
- Normal ECG
- Negative urine HCG at screening for women who are able to become pregnant.
Who cannot join
- Any prior use of statin therapy
- History of coronary disease, diabetes, hypertension, stroke, kidney disease, thyroid disease, psychiatric illness, malignancy, preeclampsia, or illness requiring overnight hospitalization in the past 6 months
- Triglycerides > 500, LDL > 200
- Any prescription medication or herbal medication including oral contraceptive, excluding thyroid medications
- Unstable thyroid disease (determined by abnormal TSH)
- Pregnancy or current breastfeeding
- Alcohol intake >12 oz per week
- Tobacco or recreational drug use
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital- 221 Longwood Avenue
Boston, Massachusetts, 02115
About this study
The purpose of this research protocol is to determine if the same effects are observed in vivo in humans through a randomized controlled study. Data regarding a novel mechanism of the widely used statin class of medications on the mineralocorticoid pathway would likely have significant clinical implications on the future management of hypertension and other cardiovascular disease given the known pleiotropy of aldosterone action.
Read the detailed description
In order to provide additional evidence regarding the effect of statin therapy on aldosterone levels, the investigators propose the following randomized, double-blinded, placebo controlled protocol in relatively healthy volunteers. The investigators will evaluate aldosterone and cortisol production in response to an angiotensin II infusion under the following test conditions: 1) placebo, 2) simvastatin therapy (lipophilic statin), and 3) pravastatin therapy (hydrophilic statin). Measurements will be made to assess the effect of both acute (single dose) and chronic (6 and 12 weeks) therapy of the two statin medications.
- Conditions
- Healthy Subjects
- Being tested
- Simvastatin, Pravastatin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
Also called Zocor
Simvastatin 20 mg daily followed by potential increase to 40 mg simvastatin according to dose escalation procedure
PravastatinDrug
Also called Pravachol
Pravastatin 40 mg daily followed by potential increase to 80 mg pravastatin according to dose escalation procedure
PlaceboOther
Placebo prepared by Investigation Drug Services at Brigham and Women's Hospital
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo prepared by Investigational Drug Services at Brigham and Women's Hospital Receives: Other: Placebo |
| Simvastatin | Active comparator | Subjects in the simvastatin arm will receive simvastatin 20 mg daily for 6 weeks before having their lipids checked. If their LDL-c decreases by less than 35% from screening, then the dose of simvastatin is increased to 40 mg daily for the following 6 weeks. Receives: Drug: Simvastatin |
| Pravastatin | Active comparator | Subjects in the pravastatin arm will receive pravastatin 40 mg daily for 6 weeks before having their lipids checked. If their LDL-c decreases by less than 35% from screening, then the dose of pravastatin is increased to 80 mg daily for the following 6 weeks. Receives: Drug: Pravastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum aldosterone following angiotensin II infusion
Measured: 3 months
Secondary outcomes (2)
24 hour urine aldosterone
Measured: Baseline
24 hour urine aldosterone
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 posted18 Aug 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2021
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan S. Williams, MD, MMSc, Brigham and Women's Hospital
- Investigators
- Jonathan Williams, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871687
- Sponsor's protocol ID
- 2016P000094
- Status last verified
- Sep 2022
- First submitted
- 15 Aug 2016
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Baudrand R, Pojoga LH, Vaidya A, Garza AE, Vohringer PA, Jeunemaitre X, Hopkins PN, Yao TM, Williams J, Adler GK, Williams GH. Statin Use and Adrenal Aldosterone Production in Hypertensive and Diabetic Subjects. Circulation. 2015 Nov 10;132(19):1825-33. doi: 10.1161/CIRCULATIONAHA.115.016759. Epub 2015 Oct 2.
PubMed 26432671Hornik ES, Altman-Merino AE, Koefoed AW, Meyer KM, Stone IB, Green JA, Williams GH, Adler GK, Williams JS. A clinical trial to evaluate the effect of statin use on lowering aldosterone levels. BMC Endocr Disord. 2020 Jul 14;20(1):105. doi: 10.1186/s12902-020-00587-4.
PubMed 32664962
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Statin Use on Aldosterone Secretion
- ClinicalTrials.gov ID
- NCT02871687
- Acronym / sponsor ID
- 2016P000094
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Mar 2021 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 18 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research protocol is to determine if the same effects are observed in vivo in humans through a randomized controlled study. Data regarding a novel mechanism of the widely used statin class of medications on the mineralocorticoid pathway would likely have significant clinical implications on the future management of hypertension and other cardiovascular disease given the known pleiotropy of aldosterone action.
Detailed description
In order to provide additional evidence regarding the effect of statin therapy on aldosterone levels, the investigators propose the following randomized, double-blinded, placebo controlled protocol in relatively healthy volunteers. The investigators will evaluate aldosterone and cortisol production in response to an angiotensin II infusion under the following test conditions: 1) placebo, 2) simvastatin therapy (lipophilic statin), and 3) pravastatin therapy (hydrophilic statin). Measurements will be made to assess the effect of both acute (single dose) and chronic (6 and 12 weeks) therapy of the two statin medications.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo prepared by Investigational Drug Services at Brigham and Women's Hospital |
| Simvastatin | Active comparator | Drug: SimvastatinSubjects in the simvastatin arm will receive simvastatin 20 mg daily for 6 weeks before having their lipids checked. If their LDL-c decreases by less than 35% from screening, then the dose of simvastatin is increased to 40 mg daily for the following 6 weeks. |
| Pravastatin | Active comparator | Drug: PravastatinSubjects in the pravastatin arm will receive pravastatin 40 mg daily for 6 weeks before having their lipids checked. If their LDL-c decreases by less than 35% from screening, then the dose of pravastatin is increased to 80 mg daily for the following 6 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Blood pressure <140/90 mmHg and >90/50 mmHg
- Body mass index 19-40 kg/m2
- Normal screening laboratory values for:
- Normal ECG
- Negative urine HCG at screening for women who are able to become pregnant.
Key exclusion criteria (8 listed)
- Any prior use of statin therapy
- History of coronary disease, diabetes, hypertension, stroke, kidney disease, thyroid disease, psychiatric illness, malignancy, preeclampsia, or illness requiring overnight hospitalization in the past 6 months
- Triglycerides > 500, LDL > 200
- Any prescription medication or herbal medication including oral contraceptive, excluding thyroid medications
- Unstable thyroid disease (determined by abnormal TSH)
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 |
|---|---|---|
| SimvastatinAlso: ZocorSimvastatin 20 mg daily followed by potential increase to 40 mg simvastatin according to dose escalation procedure | Drug | Simvastatin |
| PravastatinAlso: PravacholPravastatin 40 mg daily followed by potential increase to 80 mg pravastatin according to dose escalation procedure | Drug | Pravastatin |
| PlaceboPlacebo prepared by Investigation Drug Services at Brigham and Women's Hospital | Other | Placebo |
Primary outcome
Serum aldosterone following angiotensin II infusion
Time frame: 3 months
2 secondary outcomes
24 hour urine aldosterone
Time frame: Baseline
24 hour urine aldosterone
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Background: PubMed 26432671Baudrand R, Pojoga LH, Vaidya A, Garza AE, Vohringer PA, Jeunemaitre X, Hopkins PN, Yao TM, Williams J, Adler GK, Williams GH. Statin Use and Adrenal Aldosterone Production in Hypertensive and Diabetic Subjects. Circulation. 2015 Nov 10;132(19):1825-33. doi: 10.1161/CIRCULATIONAHA.115.016759. Epub 2015 Oct 2.
- Derived from this study: PubMed 32664962Hornik ES, Altman-Merino AE, Koefoed AW, Meyer KM, Stone IB, Green JA, Williams GH, Adler GK, Williams JS. A clinical trial to evaluate the effect of statin use on lowering aldosterone levels. BMC Endocr Disord. 2020 Jul 14;20(1):105. doi: 10.1186/s12902-020-00587-4.
- Individual participant dataSharing planned: No
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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.
Jonathan Williams, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Simvastatin and Pravastatin in people with Healthy Subjects, run by Brigham and Women's Hospital at 1 site 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 6 inclusion and 8 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 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serum aldosterone following angiotensin II infusion (time frame: 3 months). 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 NCT02871687, which also lists 2 linked publications.
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 29 Sep 2022.