Trial Outcomes & Findings for The Renin-Angiotensin-Aldosterone System and Parathyroid Hormone Control: The RAAS-PARC Study (NCT NCT01691781)

NCT ID: NCT01691781

Last Updated: 2017-09-21

Results Overview

PTH values 1 week following ACE inhibitor therapy

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 41 participants
• Primary outcome timeframe: 1 week
• Results posted on: 2017-09-21

Participant Flow

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.

Participant milestones

Measure	Primary Hyperparathyroidism Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.	Normal Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.
Overall Study STARTED	19	22
Overall Study COMPLETED	12	15
Overall Study NOT COMPLETED	7	7

Reasons for withdrawal

Measure	Primary Hyperparathyroidism Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.	Normal Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.
Overall Study Withdrawal by Subject	4	3
Overall Study Physician Decision	1	1
Overall Study Protocol Violation	2	2
Overall Study Adverse Event	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Primary Hyperparathyroidism n=12 Participants Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.	Normals n=15 Participants Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.	Total n=27 Participants Total of all reporting groups
Age, Continuous	51.4 years STANDARD_DEVIATION 15.6 • n=5 Participants	39.6 years STANDARD_DEVIATION 12.7 • n=7 Participants	44.9 years STANDARD_DEVIATION 15.3 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Parathyroid Hormone at Baseline	79.5 pg/mL STANDARD_DEVIATION 21.6 • n=5 Participants	33.3 pg/mL STANDARD_DEVIATION 25.4 • n=7 Participants	53.8 pg/mL STANDARD_DEVIATION 33.0 • n=5 Participants
Serum calcium	10.6 mg/dL STANDARD_DEVIATION 0.5 • n=5 Participants	9.4 mg/dL STANDARD_DEVIATION 0.4 • n=7 Participants	9.9 mg/dL STANDARD_DEVIATION 0.7 • n=5 Participants
Urinary Aldosterone Excretion Rate at baseline	11.7 mcg/24 hours STANDARD_DEVIATION 18.3 • n=5 Participants	5.7 mcg/24 hours STANDARD_DEVIATION 3.5 • n=7 Participants	8.2 mcg/24 hours STANDARD_DEVIATION 12.2 • n=5 Participants

PRIMARY outcome

Timeframe: 1 week

PTH values 1 week following ACE inhibitor therapy

Outcome measures

Measure	Primary Hyperparathyroidism n=12 Participants Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.	Normal n=15 Participants Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.
Parathyroid Hormone Following 1 Week of ACE Inhibitor Administration	70.9 pg/mL Standard Deviation 19.6	32.5 pg/mL Standard Deviation 16.7

SECONDARY outcome

Timeframe: 1 week

Outcome measures

Measure	Primary Hyperparathyroidism n=12 Participants Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.	Normal n=15 Participants Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.
Urinary Aldosterone Excretion Measurements Following 1 Week of ACE Inhibitor Therapy	7.8 mcg/24 hours Standard Deviation 8.9	6.1 mcg/24 hours Standard Deviation 9.1

SECONDARY outcome

Timeframe: 1 week

Outcome measures

Measure	Primary Hyperparathyroidism n=12 Participants Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.	Normal n=15 Participants Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.
Serum Calcium Following 1 Week of ACE Inhibitor Administration	10.5 mg/dL Standard Deviation 0.4	9.5 mg/dL Standard Deviation 0.3

Adverse Events

Primary Hyperparathyroidism

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Normal

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Primary Hyperparathyroidism n=12 participants at risk Participants with Primary Hyperparathyroidism enrolled to receive open label lisinopril.	Normal n=15 participants at risk Participants without primary hyperparathyroidism enrolled to receive open label lisinopril.
General disorders Weakness	8.3% 1/12 • Number of events 1 • 4 years	0.00% 0/15 • 4 years
Musculoskeletal and connective tissue disorders Musculoskeletal pain	8.3% 1/12 • Number of events 1 • 4 years	0.00% 0/15 • 4 years
Gastrointestinal disorders diarrhea	0.00% 0/12 • 4 years	6.7% 1/15 • Number of events 1 • 4 years

Additional Information

Anand Vaidya

Brigham and Women's Hospital

Phone: 6175258285

Email: avaidya1@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place