NCT01691781

Brief Summary

This study will evaluate whether commonly used blood pressure medications called "ACE inhibitors" can lower parathyroid hormone.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2012

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
8 months until next milestone

Results Posted

Study results publicly available

August 10, 2017

Completed
Last Updated

September 21, 2017

Status Verified

August 1, 2017

Enrollment Period

3.8 years

First QC Date

September 20, 2012

Results QC Date

June 19, 2017

Last Update Submit

August 18, 2017

Conditions

Hyperparathyroidism

Keywords

HyperparathyroidismRenin-angiotensin-aldosterone systemACE inhibitors

Outcome Measures

Primary Outcomes (1)

  • Parathyroid Hormone Following 1 Week of ACE Inhibitor Administration

    PTH values 1 week following ACE inhibitor therapy

    1 week

Secondary Outcomes (2)

  • Urinary Aldosterone Excretion Measurements Following 1 Week of ACE Inhibitor Therapy

    1 week

  • Serum Calcium Following 1 Week of ACE Inhibitor Administration

    1 week

Study Arms (1)

lisinopril

EXPERIMENTAL

Lisinopril - open-label, 2.5-40mg daily

Drug: Lisinopril

Interventions

LisinoprilDRUG

Each subject will receive one week of lisinopril and return for repeat for blood measurements.

lisinopril

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • 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.

    PMID: 28808443DERIVED

MeSH Terms

Conditions

Hyperparathyroidism

Interventions

Lisinopril

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

DipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Limitations and Caveats

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.

Results Point of Contact

Title
Anand Vaidya
Organization
Brigham and Women's Hospital
avaidya1@partners.org
6175258285

Study Officials

  • Anand Vaidya, MD, MMSc

    Brigham and Women's Hospital, Harvard Medical School

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Open Label
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 20, 2012

First Posted

September 25, 2012

Study Start

October 1, 2012

Primary Completion

August 1, 2016

Study Completion

December 1, 2016

Last Updated

September 21, 2017

Results First Posted

August 10, 2017

Record last verified: 2017-08

Locations

US(1)