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This study will evaluate whether commonly used blood pressure medications called "ACE inhibitors" can lower parathyroid hormone.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lisinopril | Experimental | Lisinopril - open-label, 2.5-40mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lisinopril | Drug | Each subject will receive one week of lisinopril and return for repeat for blood measurements. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Parathyroid Hormone Following 1 Week of ACE Inhibitor Administration | PTH values 1 week following ACE inhibitor therapy | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Aldosterone Excretion Measurements Following 1 Week of ACE Inhibitor Therapy | 1 week | |
| Serum Calcium Following 1 Week of ACE Inhibitor Administration | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anand Vaidya, MD, MMSc | Brigham and Women's Hospital, Harvard Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28808443 | Derived | 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. |
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All enrolled participants had to undergo a washout of ACE inhibitors (if applicable) during which time their blood pressure had to remain within safety parameters, and they had to complete a controlled sodium diet.
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| ID | Title | Description |
|---|---|---|
| FG000 | Primary Hyperparathyroidism | Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril. |
| FG001 | Normal | Participants without primary hyperparathyroidism enrolled to receive open label lisinopril. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Primary Hyperparathyroidism | Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril. |
| BG001 | Normals | Participants without primary hyperparathyroidism enrolled to receive open label lisinopril. |
| 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 | Parathyroid Hormone Following 1 Week of ACE Inhibitor Administration | PTH values 1 week following ACE inhibitor therapy | Posted | Mean | Standard Deviation | pg/mL | 1 week |
|
|
4 years
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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 | Primary Hyperparathyroidism | Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weakness | General disorders | Systematic Assessment |
This a small physiology pilot study that is open-label and non-randomized. The intervention was an ACE inhibitor, an approved therapy. Results have physiologic implications, but treatment implications are not intended.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anand Vaidya | Brigham and Women's Hospital | 6175258285 | avaidya1@partners.org |
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| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D017706 | Lisinopril |
| ID | Term |
|---|---|
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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Open Label
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| Protocol Violation |
|
| Adverse Event |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Parathyroid Hormone at Baseline | Mean | Standard Deviation | pg/mL |
|
| Serum calcium | Mean | Standard Deviation | mg/dL |
|
| Urinary Aldosterone Excretion Rate at baseline | Mean | Standard Deviation | mcg/24 hours |
|
| Participants |
|
|
|
| Secondary | Urinary Aldosterone Excretion Measurements Following 1 Week of ACE Inhibitor Therapy | Posted | Mean | Standard Deviation | mcg/24 hours | 1 week |
|
|
|
|
| Secondary | Serum Calcium Following 1 Week of ACE Inhibitor Administration | Posted | Mean | Standard Deviation | mg/dL | 1 week |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 2 |
| 12 |
| EG001 | Normal | Participants without primary hyperparathyroidism enrolled to receive open label lisinopril. | 0 | 15 | 0 | 15 | 1 | 15 |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
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The statistical analysis compared the change in urinary aldosterone excretion rate, before and after ACE inhibitor therapy, among normal control participants without primary hyperparathyroidism. |
| t-test, 2 sided |
| 0.86 |
This p-value reflects the mean difference in 24h aldosterone excretion rate among normal control participants without primary hyperparathyroidism |
| Superiority |
The statistical analysis compared the change in serum calcium, before and after ACE inhibitor therapy, among normal control participants without primary hyperparathyroidism. |
| t-test, 2 sided |
| 0.80 |
This p-value reflects the statistic for the comparison of mean calcium levels for the normal control participants without primary hyperparathyroidism. |
| Superiority |