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Trial record 22 of 222 for:    Aldosterone

The Renin-Angiotensin-Aldosterone System and Parathyroid Hormone Control: The RAAS-PARC Study (RAAS-PARC)

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ClinicalTrials.gov Identifier: NCT01691781
Recruitment Status : Completed
First Posted : September 25, 2012
Results First Posted : August 10, 2017
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
Anand Vaidya, Brigham and Women's Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Hyperparathyroidism
Intervention Drug: Lisinopril
Enrollment 41
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Primary Hyperparathyroidism Normal
Hide Arm/Group Description Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril. Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.
Period Title: Overall Study
Started 19 22
Completed 12 15
Not Completed 7 7
Reason Not Completed
Withdrawal by Subject             4             3
Physician Decision             1             1
Protocol Violation             2             2
Adverse Event             0             1
Arm/Group Title Primary Hyperparathyroidism Normals Total
Hide Arm/Group Description Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril. Participants without primary hyperparathyroidism enrolled to receive open label lisinopril. Total of all reporting groups
Overall Number of Baseline Participants 12 15 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 15 participants 27 participants
51.4  (15.6) 39.6  (12.7) 44.9  (15.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 15 participants 27 participants
Female
5
  41.7%
6
  40.0%
11
  40.7%
Male
7
  58.3%
9
  60.0%
16
  59.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 15 participants 27 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   8.3%
1
   6.7%
2
   7.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  16.7%
6
  40.0%
8
  29.6%
White
9
  75.0%
8
  53.3%
17
  63.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 12 participants 15 participants 27 participants
12
 100.0%
15
 100.0%
27
 100.0%
Parathyroid Hormone at Baseline  
Mean (Standard Deviation)
Unit of measure:  pg/mL
Number Analyzed 12 participants 15 participants 27 participants
79.5  (21.6) 33.3  (25.4) 53.8  (33.0)
Serum calcium  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 12 participants 15 participants 27 participants
10.6  (0.5) 9.4  (0.4) 9.9  (0.7)
Urinary Aldosterone Excretion Rate at baseline  
Mean (Standard Deviation)
Unit of measure:  Mcg/24 hours
Number Analyzed 12 participants 15 participants 27 participants
11.7  (18.3) 5.7  (3.5) 8.2  (12.2)
1.Primary Outcome
Title Parathyroid Hormone Following 1 Week of ACE Inhibitor Administration
Hide Description PTH values 1 week following ACE inhibitor therapy
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Primary Hyperparathyroidism Normal
Hide Arm/Group Description:
Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.
Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.
Overall Number of Participants Analyzed 12 15
Mean (Standard Deviation)
Unit of Measure: pg/mL
70.9  (19.6) 32.5  (16.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primary Hyperparathyroidism
Comments The statistical analysis compared the change in PTH, before and after ACE inhibitor therapy, among participants with primary hyperparathyroidism.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments This p-value reflects the difference in PTH means among participants with primary hyperparathyroidism
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Normal
Comments The statistical analysis compared the change in PTH, before and after ACE inhibitor therapy, among normal control participants (without primary hyperparathyroidism).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments This p-value reflects the difference in PTH means among normal control participants without primary hyperparathyroidism
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Urinary Aldosterone Excretion Measurements Following 1 Week of ACE Inhibitor Therapy
Hide Description [Not Specified]
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Primary Hyperparathyroidism Normal
Hide Arm/Group Description:
Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.
Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.
Overall Number of Participants Analyzed 12 15
Mean (Standard Deviation)
Unit of Measure: mcg/24 hours
7.8  (8.9) 6.1  (9.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primary Hyperparathyroidism
Comments The statistical analysis compared the change in urinary aldosterone excretion rate, before and after ACE inhibitor therapy, among participants with primary hyperparathyroidism.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments This p-value reflects the comparison of means among the primary hyperparathyroidism group only.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Normal
Comments The statistical analysis compared the change in urinary aldosterone excretion rate, before and after ACE inhibitor therapy, among normal control participants without primary hyperparathyroidism.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments This p-value reflects the mean difference in 24h aldosterone excretion rate among normal control participants without primary hyperparathyroidism
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Serum Calcium Following 1 Week of ACE Inhibitor Administration
Hide Description [Not Specified]
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Primary Hyperparathyroidism Normal
Hide Arm/Group Description:
Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.
Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.
Overall Number of Participants Analyzed 12 15
Mean (Standard Deviation)
Unit of Measure: mg/dL
10.5  (0.4) 9.5  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primary Hyperparathyroidism
Comments The statistical analysis compared the change in serum calcium, before and after ACE inhibitor therapy, among participants with primary hyperparathyroidism.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments This p-value reflects the statistic for the comparison of mean calcium levels for the primary hyperparathyroidism group.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Normal
Comments The statistical analysis compared the change in serum calcium, before and after ACE inhibitor therapy, among normal control participants without primary hyperparathyroidism.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments This p-value reflects the statistic for the comparison of mean calcium levels for the normal control participants without primary hyperparathyroidism.
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 4 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Primary Hyperparathyroidism Normal
Hide Arm/Group Description Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril. Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.
All-Cause Mortality
Primary Hyperparathyroidism Normal
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)      0/15 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Primary Hyperparathyroidism Normal
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Primary Hyperparathyroidism Normal
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/12 (16.67%)      1/15 (6.67%)    
Gastrointestinal disorders     
diarrhea   0/12 (0.00%)  0 1/15 (6.67%)  1
General disorders     
Weakness   1/12 (8.33%)  1 0/15 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Musculoskeletal pain   1/12 (8.33%)  1 0/15 (0.00%)  0
Indicates events were collected by 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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anand Vaidya
Organization: Brigham and Women's Hospital
Phone: 6175258285
EMail: avaidya1@partners.org
Layout table for additonal information
Responsible Party: Anand Vaidya, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01691781     History of Changes
Other Study ID Numbers: 2012p0001961
First Submitted: September 20, 2012
First Posted: September 25, 2012
Results First Submitted: June 19, 2017
Results First Posted: August 10, 2017
Last Update Posted: September 21, 2017