HyperparathyroidismRAAS-PARCNCT01691781
The Renin-Angiotensin-Aldosterone System and Parathyroid Hormone Control: The RAAS-PARC Study
A study testing Lisinopril in people with Hyperparathyroidism, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study will evaluate whether commonly used blood pressure medications called "ACE inhibitors" can lower parathyroid hormone. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperparathyroidism
- What is being tested?
- Lisinopril
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Dec 2016
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects with with no medical problems (n=15) and individuals with primary hyperparathyroidism (n=30)
- normal blood pressure or stage 1 hypertension that is either untreated, or adequately treated with a single anti-hypertensive medication.
- Age >18 years and <80 years
- Estimated GFR > 60ml/min
Who cannot join
- Chronic Kidney Disease or eGFR<60
- Stage 2 or Stage 3 hypertension or the use of more than 1 antihypertensive drug
- Type 2 Diabetes Mellitus that is not controlled by diet or Metformin alone or with a Hemoglobin A1c >7.5%
- History of liver failure
- History of heart failure
- The use of typical or atypical antipsychotic medications or lithium.
Show all 11Show fewer
- Chronic inflammatory conditions (such as inflammatory bowel disease or arthritis) that are treated with prescribed doses of NSAIDs or glucocorticoids
- The use of prescribed doses of potassium supplements.
- Illness requiring overnight hospitalization in the past 6 months
- Active tobacco or recreational drug use
- Pregnancy or current breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
This study will evaluate whether commonly used blood pressure medications called "ACE inhibitors" can lower parathyroid hormone.
Read the detailed description
The RAAS-PARC study will evaluate whether angiotensin-converting enzyme inhibitors (ACEi) can lower parathyroid hormone (PTH) in normal controls and in individuals have a diagnosis of primary hyperparathyroidism.
Emerging data has implicated the renin-angiotensin-aldosterone system (RAAS) activity with increased PTH. The principal investigator, and other investigators, have previously shown that inhibiting the RAAS may lower PTH. The current study will focus on:
- Normal Physiology: Does an ACEi (which lowers angiotensin II and aldosterone) reduce PTH in normal individuals?
- Pathophysiology: Does an ACEi reduce PTH in individuals with primary hyperparathyroidism?
The results of this study may have important implications for cardiovascular and skeletal health, as both the RAAS and PTH have been implicated as mediators of these conditions.
- Conditions
- Hyperparathyroidism
- Being tested
- Lisinopril
- Keywords
- Hyperparathyroidism, Renin-angiotensin-aldosterone system, ACE inhibitors
- Medical subject headings
- Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LisinoprilDrug
Each subject will receive one week of lisinopril and return for repeat for blood measurements.
| Study group | Role | What they receive |
|---|---|---|
| lisinopril | Experimental | Lisinopril - open-label, 2.5-40mg daily Receives: Drug: Lisinopril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parathyroid Hormone Following 1 Week of ACE Inhibitor Administration
PTH values 1 week following ACE inhibitor therapy
Measured: 1 week
Secondary outcomes (2)
Urinary Aldosterone Excretion Measurements Following 1 Week of ACE Inhibitor Therapy
Measured: 1 week
Serum Calcium Following 1 Week of ACE Inhibitor Administration
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2016
- Study completionDec 2016
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 HyperparathyroidismStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anand Vaidya, Brigham and Women's Hospital
- Investigators
- Anand Vaidya, MD, MMSc, Principal investigator, Brigham and Women's Hospital, Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691781
- Sponsor's protocol ID
- 2012p0001961
- Acronym
- RAAS-PARC
- Status last verified
- Aug 2017
- First submitted
- 20 Sep 2012
- Last updated
- 21 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Zaheer S, Brown JM, Connors M, Williams JS, Adler GK, Vaidya A. Angiotensin-Converting Enzyme Inhibition and Parathyroid Hormone Secretion. Int J Endocrinol. 2017;2017:4138783. doi: 10.1155/2017/4138783. Epub 2017 Jul 20.
PubMed 28808443
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Renin-Angiotensin-Aldosterone System and Parathyroid Hormone Control: The RAAS-PARC Study
- ClinicalTrials.gov ID
- NCT01691781
- Acronym / sponsor ID
- RAAS-PARC / 2012p0001961
- Conditions
- Hyperparathyroidism
- Keywords
- Hyperparathyroidism, Renin-angiotensin-aldosterone system, ACE inhibitors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Posted 10 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate whether commonly used blood pressure medications called "ACE inhibitors" can lower parathyroid hormone.
Detailed description
The RAAS-PARC study will evaluate whether angiotensin-converting enzyme inhibitors (ACEi) can lower parathyroid hormone (PTH) in normal controls and in individuals have a diagnosis of primary hyperparathyroidism.
Emerging data has implicated the renin-angiotensin-aldosterone system (RAAS) activity with increased PTH. The principal investigator, and other investigators, have previously shown that inhibiting the RAAS may lower PTH. The current study will focus on:
- Normal Physiology: Does an ACEi (which lowers angiotensin II and aldosterone) reduce PTH in normal individuals?
- Pathophysiology: Does an ACEi reduce PTH in individuals with primary hyperparathyroidism?
The results of this study may have important implications for cardiovascular and skeletal health, as both the RAAS and PTH have been implicated as mediators of these conditions.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lisinopril | Experimental | Drug: LisinoprilLisinopril - open-label, 2.5-40mg daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy subjects with with no medical problems (n=15) and individuals with primary hyperparathyroidism (n=30)
- normal blood pressure or stage 1 hypertension that is either untreated, or adequately treated with a single anti-hypertensive medication.
- Age >18 years and <80 years
- Estimated GFR > 60ml/min
Key exclusion criteria (11 listed)
- Chronic Kidney Disease or eGFR<60
- Stage 2 or Stage 3 hypertension or the use of more than 1 antihypertensive drug
- Type 2 Diabetes Mellitus that is not controlled by diet or Metformin alone or with a Hemoglobin A1c >7.5%
- History of liver failure
- History of heart failure
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 |
|---|---|---|
| LisinoprilEach subject will receive one week of lisinopril and return for repeat for blood measurements. | Drug | lisinopril |
Primary outcome
Parathyroid Hormone Following 1 Week of ACE Inhibitor Administration
Time frame: 1 week
PTH values 1 week following ACE inhibitor therapy
2 secondary outcomes
Urinary Aldosterone Excretion Measurements Following 1 Week of ACE Inhibitor Therapy
Time frame: 1 week
Serum Calcium Following 1 Week of ACE Inhibitor Administration
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28808443Zaheer S, Brown JM, Connors M, Williams JS, Adler GK, Vaidya A. Angiotensin-Converting Enzyme Inhibition and Parathyroid Hormone Secretion. Int J Endocrinol. 2017;2017:4138783. doi: 10.1155/2017/4138783. Epub 2017 Jul 20.
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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.
Anand Vaidya, MD, MMSc principal investigator
Brigham and Women's Hospital, Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lisinopril in people with Hyperparathyroidism, 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 4 inclusion and 11 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 21 Sep 2017. 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. 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 10 Aug 2017). 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?
Parathyroid Hormone Following 1 Week of ACE Inhibitor Administration (time frame: 1 week). 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 NCT01691781, 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 21 Sep 2017.