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Sympathetic Regulation of Large Artery Stiffness in Humans With ISH (SELECT)

Primary Purpose

Hypertension, Systolic, Stiffness, Aortic

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Clonidine

Hydrochlorothiazide

Placebo

About this trial

This is an interventional treatment trial for Hypertension, Systolic

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

age 60-85
non-smoking
clinically healthy
untreated or treated stage 1 isolated systolic hypertension (ISH) (systolic BP 130-139 mmHg; diastolic BP <90 mmHg) or stage 2 ISH (systolic BP 140-159 mmHg; diastolic BP <90 mmHg) per 2017 AHA/ACC hypertension guidelines
if subject is on antihypertensive medications, they will stop taking medication for a one-week washout period after Visit 1 before they return for Visit 2. They will come in at day 3 and day 7 of the one-week washout for a BP reading, to confirm that systolic BP is <160 mmHg.

Exclusion Criteria:

no history of cardiovascular disease (e.g., myocardial infarction, bypass surgery, angioplasty/stent, heart failure, cardiomyopathy, pacemaker/defibrillator, peripheral artery disease), pulmonary disease, liver disease, Type I or II diabetes, cancer (treated by chemotherapy and/or radiation), psychiatric illness, on aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
aspirin, NSAIDs, vitamins, herbal supplements, omega-3-fatty acids will have to discontinue for at least 1 week before participation and remain discontinued during the study.
blood thinners, serotonin reuptake inhibitors (SSRIs), or PDE5 inhibitors will also be excluded.
Women must be postmenopausal for at least 6 months (surgical or natural) and not currently on hormone replacement therapy.
Subjects not on antihypertensive will not be eligible if their resting clinic systolic BP is <130 mmHg or >160 mmHg and diastolic BP >90 mmHg.

Sites / Locations

Amy StroudRecruiting
University of IowaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Clonidine

Hydrochlorothiazide

Placebo

Arm Description

0.2 mg/day oral

37.5 mg/day oral

Placebo

Outcomes

Primary Outcome Measures

Change in carotid-femoral pulse wave velocity

Aortic stiffness

Secondary Outcome Measures

Change in carotid distensibility index

Change in carotid distensibility

Change in carotid flow pulsatility index

Change in carotid flow pulsatility

Change in carotid intimal medial thickness (IMT)

Change in carotid wall thickness

Full Information

NCT ID

NCT04423627

First Posted

June 5, 2020

Last Updated

March 26, 2023

Sponsor

University of Iowa

1. Study Identification

Unique Protocol Identification Number

NCT04423627

Brief Title

Sympathetic Regulation of Large Artery Stiffness in Humans With ISH

Acronym

SELECT

Official Title

Sympathetic Regulation of Large Artery Stiffness in Humans With Age-Related Isolated Systolic Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2021 (Actual)

Primary Completion Date

June 30, 2025 (Anticipated)

Study Completion Date

December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Iowa

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Stiffening of your blood vessels, particularly the large vessels from your heart (called the aorta and carotids) you age contributes to the development of cardiovascular disease (CVD) such as heart attack and stroke. Nerve activity from your brain to your body also increases with advancing age but it is unknown if this nerve activity contributes directly to the stiffening on your blood vessels in older adults in addition to high blood pressure. Therefore, successful completion of the proposed aims will have a significant clinical impact by identifying if nerve activity from your brain could be a novel target for therapies that would lower stiffness of the aorta and carotid arteries in older adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Systolic, Stiffness, Aortic

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Randomized, placebo controlled, parallel design

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Clonidine

Arm Type

Experimental

Arm Description

0.2 mg/day oral

Arm Title

Hydrochlorothiazide

Arm Type

Active Comparator

Arm Description

37.5 mg/day oral

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Clonidine

Intervention Description

Clonidine 0.2 mg/day oral tablet

Intervention Type

Drug

Intervention Name(s)

Hydrochlorothiazide

Intervention Description

Hydrochlorothiazide 37.5 mg/day oral tablet

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Change in carotid-femoral pulse wave velocity

Description

Aortic stiffness

Time Frame

Baseline and after 4 weeks

Secondary Outcome Measure Information:

Title

Change in carotid distensibility index

Description

Change in carotid distensibility

Time Frame

Baseline and after 4 weeks

Title

Change in carotid flow pulsatility index

Description

Change in carotid flow pulsatility

Time Frame

Baseline and after 4 weeks

Title

Change in carotid intimal medial thickness (IMT)

Description

Change in carotid wall thickness

Time Frame

Baseline and after 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age 60-85 non-smoking clinically healthy untreated or treated stage 1 isolated systolic hypertension (ISH) (systolic BP 130-139 mmHg; diastolic BP <90 mmHg) or stage 2 ISH (systolic BP 140-159 mmHg; diastolic BP <90 mmHg) per 2017 AHA/ACC hypertension guidelines if subject is on antihypertensive medications, they will stop taking medication for a one-week washout period after Visit 1 before they return for Visit 2. They will come in at day 3 and day 7 of the one-week washout for a BP reading, to confirm that systolic BP is <160 mmHg. Exclusion Criteria: no history of cardiovascular disease (e.g., myocardial infarction, bypass surgery, angioplasty/stent, heart failure, cardiomyopathy, pacemaker/defibrillator, peripheral artery disease), pulmonary disease, liver disease, Type I or II diabetes, cancer (treated by chemotherapy and/or radiation), psychiatric illness, on aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs). aspirin, NSAIDs, vitamins, herbal supplements, omega-3-fatty acids will have to discontinue for at least 1 week before participation and remain discontinued during the study. blood thinners, serotonin reuptake inhibitors (SSRIs), or PDE5 inhibitors will also be excluded. Women must be postmenopausal for at least 6 months (surgical or natural) and not currently on hormone replacement therapy. Subjects not on antihypertensive will not be eligible if their resting clinic systolic BP is <130 mmHg or >160 mmHg and diastolic BP >90 mmHg.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amy Stroud, RN, MSN

Phone

3193849549

amy-stroud@uiowa.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Gary L Pierce, PhD

Phone

3193359487

gary-pierce@uiowa.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gary Pierce, PhD

Organizational Affiliation

University of Iowa

Official's Role

Principal Investigator

Facility Information:

Facility Name

Amy Stroud

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52240

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amy Stroud, MSN, RN

Phone

319-356-9549

amy-stroud@uiowa.edu

First Name & Middle Initial & Last Name & Degree

Gary L Pierce, PhD

Facility Name

University of Iowa

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amy Stroud, MSN, RN

Phone

319-384-9549

amy-stroud@uiowa.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Sympathetic Regulation of Large Artery Stiffness in Humans With ISH

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