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Vericiguat in Patients With Metabolic Syndrome and Coronary Vascular Dysfunction

Primary Purpose

Metabolic Syndrome, Coronary Microvascular Dysfunction

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vericiguat
Placebo
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring Cardiac Magnetic Resonance Imaging

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age range 35-85 years Presence of the metabolic syndrome defined by the National Cholesterol Education Program, Adult Treatment Panel III (NCEP ATP III) definition, with at least three of the following five criteria: waist circumference > 40 inches (men) or >35 inches (women) blood pressure >130/80 mmHg fasting triglyceride (TG) level >150 mg/dL fasting high-density lipoprotein (HDL) cholesterol level <40mg/dL in men or <50mg/dL in women Fasting blood glucose >100 mg/dL Either one of the following: Men ≤ 40 or women ≤ 50 years of age with no history or symptoms of ischemic heart disease, or Men >40 or women >50 years of age with either one of the following a coronary angiography within the past 24 months showing no significant coronary artery disease, defined as >50% stenosis of the left main coronary artery and/or >70% stenosis of another major coronary vessel, or a coronary artery calcium score obtained within the prior 24 months or if no prior calcium scan, one performed as a research study following consent with a score equal to 0 IHE-induced %-change in coronary flow ≤13% Exclusion Criteria: Systolic blood pressure <110 mm Hg Current or anticipated use of long-acting nitrates, soluble guanylate cyclase (sGC) stimulators, or phosphodiesterase type 5 (PDE5) inhibitors Hematocrit <30% Unable to understand the risks, benefits, and alternatives of participation so as to provide informed consent Women who are pregnant. Women with reproductive capacity not using an acceptable form of contraception History of claustrophobia Inability to lie flat and still for 45 minutes Presence of non-magnetic resonance (MR)-compatible objects or devices, such as intra-orbital debris, intra-auricular implants, intra-cranial clips, an implanted defibrillator or a pacemaker History as a machinist, welder, metal worker or a similar activity that poses the risk of metal exposure to the eyes

Sites / Locations

  • Johns Hopkins HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vericiguat

Placebo

Arm Description

Initial 2.5 mg/day for two weeks, then 5 mg/day for two weeks, and then 10 mg/day for two weeks. Systolic blood pressure will be measured before and following each titration The participant will receive the final titration dose for a total of six weeks.. The drug is administered as an oral tablet once daily.

A placebo tablet will be administered orally once daily.

Outcomes

Primary Outcome Measures

Absolute change in coronary flow (in mL/min) within the vericiguat group as assessed by Magnetic Resonance Imaging (MRI)
The absolute changes in coronary flow (in mL/min) with isometric handgrip exercise (IHE) in the group randomized to vericiguat from that measured at baseline, prior to the initiation of vericiguat, to that measured at the end of the study drug administration period as assessed by MRI.
Relative change in coronary flow (as percentage) within the vericiguat group as assessed by Magnetic Resonance Imaging (MRI)
The relative changes in coronary flow (as percentage) with isometric handgrip exercise (IHE) in the group randomized to vericiguat from that measured at baseline, prior to the initiation of vericiguat, to that measured at the end of the study drug administration period as assessed by MRI.
Absolute change in coronary cross-sectional area (in mm²) within the vericiguat group as assessed by Magnetic Resonance Imaging (MRI)
The absolute changes in coronary cross-sectional area (in mm²) with isometric handgrip exercise (IHE) in the group randomized to vericiguat from that measured at baseline, prior to the initiation of vericiguat, to that measured at the end of the study drug administration period as assessed by MRI.
Relative change in coronary cross-sectional area (as percentage) within the vericiguat group as assessed by Magnetic Resonance Imaging (MRI)
The relative changes in coronary cross-sectional area (as percentage) with isometric handgrip exercise (IHE) in the group randomized to vericiguat from that measured at baseline, prior to the initiation of vericiguat, to that measured at the end of the study drug administration period as assessed by MRI.
Absolute change in coronary flow (in mL/min) between the vericiguat group and the placebo group as assessed by Magnetic Resonance Imaging (MRI)
The absolute changes in coronary flow (in mL/min) with isometric handgrip exercise (IHE) in the vericiguat group as compared to the placebo group as assessed by MRI.
Relative change in coronary flow (as percentage) between the vericiguat group and the placebo group as assessed by Magnetic Resonance Imaging (MRI)
The relative changes in in coronary flow (as percentage) with isometric handgrip exercise (IHE) in the vericiguat group as compared to the placebo group as assessed by MRI.
Absolute change in coronary cross-sectional area (in mm²) between the vericiguat group and the placebo group as assessed by Magnetic Resonance Imaging (MRI)
The absolute changes in coronary cross-sectional area (in mm²) with isometric handgrip exercise (IHE) in the vericiguat group as compared to the placebo group as assessed by MRI.
Relative change in coronary cross-sectional area (as percentage) between the vericiguat group and the placebo group as assessed by Magnetic Resonance Imaging (MRI)
The relative changes in coronary cross-sectional area (as percentage) with isometric handgrip exercise (IHE) in the vericiguat group as compared to the placebo group as assessed by MRI.

Secondary Outcome Measures

Changes in interleukin 1 (IL-1) measured using blood samples (in pg/mL)
IL-1 (in pg/mL), an inflammatory marker, will be measured in blood samples to assess changes from baseline.
Changes in interleukin 6 (IL-6) measured using blood samples (in pg/mL)
IL-6 (in pg/mL), an inflammatory marker, will be measured in blood samples to assess changes from baseline.
Changes in interleukin 10 (IL-10) measured using blood samples (in pg/mL)
IL-10 (in pg/mL), an inflammatory marker, will be measured in blood samples to assess changes from baseline.
Changes in tumor necrosis factor (TNF)-alpha measured using blood samples (in pg/mL)
TNF-alpha (in pg/mL), an inflammatory marker, will be measured in blood samples to assess changes from baseline.
Changes in high sensitivity C-Reactive Protein (hsCRP) measured using blood samples (in mg/L)
hsCRP (in mg/L), an inflammatory marker, will be measured in blood samples to assess changes from baseline.
Changes in cyclic guanosine monophosphate (cGMP) measured using blood samples (in pmol/mL)
cGMP (in pmol/mL), a mediator in the nitric oxide pathway, will be measured in blood samples to assess changes from baseline.
Changes in left ventricular ejection fraction (as percentage) as assessed by echocardiography
An ultrasound evaluation of the heart will be performed to assess the impact of vericiguat on left ventricular ejection fraction (%).
Changes in e' velocities (in cm/s) as assessed by echocardiography
An ultrasound evaluation of the heart will be performed to assess the impact of vericiguat on e' velocities (in cm/s).
Changes in E/e' ratio as assessed by echocardiography
An ultrasound evaluation of the heart will be performed to assess the impact of vericiguat on the E/e' ratio.
Changes in left atrium volume index (in mL/BSA) as assessed by echocardiography
An ultrasound evaluation of the heart will be performed to assess the impact of vericiguat on the left atrium volume index (in mL/BSA).
Changes in peak tricuspid regurgitation (TR) velocity (in m/s) as assessed by echocardiography
An ultrasound evaluation of the heart will be performed to assess the impact of vericiguat on peak TR velocity (in m/s).
Changes in strain (as percentage) as assessed by echocardiography
An ultrasound evaluation of the heart will be performed to assess the impact of vericiguat on strain (as percentage).

Full Information

First Posted
December 6, 2022
Last Updated
June 16, 2023
Sponsor
Johns Hopkins University
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05711719
Brief Title
Vericiguat in Patients With Metabolic Syndrome and Coronary Vascular Dysfunction
Official Title
Vericiguat in Patients With Metabolic Syndrome and Coronary Vascular Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2023 (Actual)
Primary Completion Date
June 16, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Coronary vascular dysfunction is one of the "final common pathways" for the impact of multiple cardiovascular risk factors. The investigators will conduct a randomized, double-blind placebo-controlled study in individuals with the metabolic syndrome and baseline coronary vascular dysfunction to evaluate the impact of vericiguat, a stimulator of soluble guanylyl cyclase, on coronary vascular function using non-invasive cardiac magnetic resonance imaging.
Detailed Description
Despite advances in medical therapy for the prevention of coronary artery disease, such as the treatments for high blood pressure and elevated cholesterol, several hundred thousand Americans continue to experience heart attacks every year. This may be related to risk factors which are not now identified and therefore treated. Endothelial dysfunction indexes the adverse impact of multiple risk factors and thus provides the opportunity to evaluate the benefit of an intervention which may improve function. Forty-five participants with metabolic syndrome and coronary vascular dysfunction will be randomized in a 2:1 ratio to receive vericiguat or placebo. Following randomization, the participants will undergo a study drug titration phase as follows: Initial 2.5 mg/day for two weeks, then 5 mg/day for two weeks, and then 10 mg/day for two weeks. This titration protocol is the one stated in the FDA package insert for vericiguat. The vericiguat formulary will be an FDA approved version obtained by the Johns Hopkins Medical Institutions Pharmacy from Merck (manufacturer of vericiguat) and will be maintained by the Johns Hopkins Investigational Drug Service until it is administered. Cardiac MRI with isometric handgrip exercise, as well as echocardiography and blood studies will be used to assess coronary vascular and cardiac function and biomarkers indicative of nitric oxide pathways and factors impacting that pathway. The same procedures will be repeated at the end of the 6-10 week study drug administration period with an identical protocol, with special attention taken on the MRI to interrogate the same coronary segments as those studied at baseline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Coronary Microvascular Dysfunction
Keywords
Cardiac Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Double-blind, placebo controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vericiguat
Arm Type
Experimental
Arm Description
Initial 2.5 mg/day for two weeks, then 5 mg/day for two weeks, and then 10 mg/day for two weeks. Systolic blood pressure will be measured before and following each titration The participant will receive the final titration dose for a total of six weeks.. The drug is administered as an oral tablet once daily.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A placebo tablet will be administered orally once daily.
Intervention Type
Drug
Intervention Name(s)
Vericiguat
Other Intervention Name(s)
Verquvo
Intervention Description
Up-titration will be performed as guided by the evaluation of blood pressure and clinical symptoms
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered the same way
Primary Outcome Measure Information:
Title
Absolute change in coronary flow (in mL/min) within the vericiguat group as assessed by Magnetic Resonance Imaging (MRI)
Description
The absolute changes in coronary flow (in mL/min) with isometric handgrip exercise (IHE) in the group randomized to vericiguat from that measured at baseline, prior to the initiation of vericiguat, to that measured at the end of the study drug administration period as assessed by MRI.
Time Frame
Baseline and 6 weeks following initiation of up-titrated dose
Title
Relative change in coronary flow (as percentage) within the vericiguat group as assessed by Magnetic Resonance Imaging (MRI)
Description
The relative changes in coronary flow (as percentage) with isometric handgrip exercise (IHE) in the group randomized to vericiguat from that measured at baseline, prior to the initiation of vericiguat, to that measured at the end of the study drug administration period as assessed by MRI.
Time Frame
Baseline and 6 weeks following initiation of up-titrated dose
Title
Absolute change in coronary cross-sectional area (in mm²) within the vericiguat group as assessed by Magnetic Resonance Imaging (MRI)
Description
The absolute changes in coronary cross-sectional area (in mm²) with isometric handgrip exercise (IHE) in the group randomized to vericiguat from that measured at baseline, prior to the initiation of vericiguat, to that measured at the end of the study drug administration period as assessed by MRI.
Time Frame
Baseline and 6 weeks following initiation of up-titrated dose
Title
Relative change in coronary cross-sectional area (as percentage) within the vericiguat group as assessed by Magnetic Resonance Imaging (MRI)
Description
The relative changes in coronary cross-sectional area (as percentage) with isometric handgrip exercise (IHE) in the group randomized to vericiguat from that measured at baseline, prior to the initiation of vericiguat, to that measured at the end of the study drug administration period as assessed by MRI.
Time Frame
Baseline and 6 weeks following initiation of up-titrated dose
Title
Absolute change in coronary flow (in mL/min) between the vericiguat group and the placebo group as assessed by Magnetic Resonance Imaging (MRI)
Description
The absolute changes in coronary flow (in mL/min) with isometric handgrip exercise (IHE) in the vericiguat group as compared to the placebo group as assessed by MRI.
Time Frame
Baseline and 6 weeks following initiation of up-titrated dose
Title
Relative change in coronary flow (as percentage) between the vericiguat group and the placebo group as assessed by Magnetic Resonance Imaging (MRI)
Description
The relative changes in in coronary flow (as percentage) with isometric handgrip exercise (IHE) in the vericiguat group as compared to the placebo group as assessed by MRI.
Time Frame
Baseline and 6 weeks following initiation of up-titrated dose
Title
Absolute change in coronary cross-sectional area (in mm²) between the vericiguat group and the placebo group as assessed by Magnetic Resonance Imaging (MRI)
Description
The absolute changes in coronary cross-sectional area (in mm²) with isometric handgrip exercise (IHE) in the vericiguat group as compared to the placebo group as assessed by MRI.
Time Frame
Baseline and 6 weeks following initiation of up-titrated dose
Title
Relative change in coronary cross-sectional area (as percentage) between the vericiguat group and the placebo group as assessed by Magnetic Resonance Imaging (MRI)
Description
The relative changes in coronary cross-sectional area (as percentage) with isometric handgrip exercise (IHE) in the vericiguat group as compared to the placebo group as assessed by MRI.
Time Frame
Baseline and 6 weeks following initiation of up-titrated dose
Secondary Outcome Measure Information:
Title
Changes in interleukin 1 (IL-1) measured using blood samples (in pg/mL)
Description
IL-1 (in pg/mL), an inflammatory marker, will be measured in blood samples to assess changes from baseline.
Time Frame
Baseline and 6 weeks following initiation of up-titrated dose
Title
Changes in interleukin 6 (IL-6) measured using blood samples (in pg/mL)
Description
IL-6 (in pg/mL), an inflammatory marker, will be measured in blood samples to assess changes from baseline.
Time Frame
Baseline and 6 weeks following initiation of up-titrated dose
Title
Changes in interleukin 10 (IL-10) measured using blood samples (in pg/mL)
Description
IL-10 (in pg/mL), an inflammatory marker, will be measured in blood samples to assess changes from baseline.
Time Frame
Baseline and 6 weeks following initiation of up-titrated dose
Title
Changes in tumor necrosis factor (TNF)-alpha measured using blood samples (in pg/mL)
Description
TNF-alpha (in pg/mL), an inflammatory marker, will be measured in blood samples to assess changes from baseline.
Time Frame
Baseline and 6 weeks following initiation of up-titrated dose
Title
Changes in high sensitivity C-Reactive Protein (hsCRP) measured using blood samples (in mg/L)
Description
hsCRP (in mg/L), an inflammatory marker, will be measured in blood samples to assess changes from baseline.
Time Frame
Baseline and 6 weeks following initiation of up-titrated dose
Title
Changes in cyclic guanosine monophosphate (cGMP) measured using blood samples (in pmol/mL)
Description
cGMP (in pmol/mL), a mediator in the nitric oxide pathway, will be measured in blood samples to assess changes from baseline.
Time Frame
Baseline and 6 weeks following initiation of up-titrated dose
Title
Changes in left ventricular ejection fraction (as percentage) as assessed by echocardiography
Description
An ultrasound evaluation of the heart will be performed to assess the impact of vericiguat on left ventricular ejection fraction (%).
Time Frame
Baseline and 6 weeks following initiation of up-titrated dose
Title
Changes in e' velocities (in cm/s) as assessed by echocardiography
Description
An ultrasound evaluation of the heart will be performed to assess the impact of vericiguat on e' velocities (in cm/s).
Time Frame
Baseline and 6 weeks following initiation of up-titrated dose
Title
Changes in E/e' ratio as assessed by echocardiography
Description
An ultrasound evaluation of the heart will be performed to assess the impact of vericiguat on the E/e' ratio.
Time Frame
Baseline and 6 weeks following initiation of up-titrated dose
Title
Changes in left atrium volume index (in mL/BSA) as assessed by echocardiography
Description
An ultrasound evaluation of the heart will be performed to assess the impact of vericiguat on the left atrium volume index (in mL/BSA).
Time Frame
Baseline and 6 weeks following initiation of up-titrated dose
Title
Changes in peak tricuspid regurgitation (TR) velocity (in m/s) as assessed by echocardiography
Description
An ultrasound evaluation of the heart will be performed to assess the impact of vericiguat on peak TR velocity (in m/s).
Time Frame
Baseline and 6 weeks following initiation of up-titrated dose
Title
Changes in strain (as percentage) as assessed by echocardiography
Description
An ultrasound evaluation of the heart will be performed to assess the impact of vericiguat on strain (as percentage).
Time Frame
Baseline and 6 weeks following initiation of up-titrated dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age range 35-85 years Presence of the metabolic syndrome defined by the National Cholesterol Education Program, Adult Treatment Panel III (NCEP ATP III) definition, with at least three of the following five criteria: waist circumference > 40 inches (men) or >35 inches (women) blood pressure >130/80 mmHg fasting triglyceride (TG) level >150 mg/dL fasting high-density lipoprotein (HDL) cholesterol level <40mg/dL in men or <50mg/dL in women Fasting blood glucose >100 mg/dL Either one of the following: Men ≤ 40 or women ≤ 50 years of age with no history or symptoms of ischemic heart disease, or Men >40 or women >50 years of age with either one of the following a coronary angiography within the past 24 months showing no significant coronary artery disease, defined as >50% stenosis of the left main coronary artery and/or >70% stenosis of another major coronary vessel, or a coronary artery calcium score obtained within the prior 24 months or if no prior calcium scan, one performed as a research study following consent with a score equal to 0 IHE-induced %-change in coronary flow ≤13% Exclusion Criteria: Systolic blood pressure <110 mm Hg Current or anticipated use of long-acting nitrates, soluble guanylate cyclase (sGC) stimulators, or phosphodiesterase type 5 (PDE5) inhibitors Hematocrit <30% Unable to understand the risks, benefits, and alternatives of participation so as to provide informed consent Women who are pregnant. Women with reproductive capacity not using an acceptable form of contraception History of claustrophobia Inability to lie flat and still for 45 minutes Presence of non-magnetic resonance (MR)-compatible objects or devices, such as intra-orbital debris, intra-auricular implants, intra-cranial clips, an implanted defibrillator or a pacemaker History as a machinist, welder, metal worker or a similar activity that poses the risk of metal exposure to the eyes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thorsten M Leucker, M.D., Ph.D.
Phone
410-502-9453
Email
tleucke1@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Gary Gerstenblith, M.D.
Phone
410-955-6835
Email
gblith@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thorsten M Leucker, M.D., Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frances Kirkland
Phone
410-955-3855
Email
fkirkla1@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Thorsten M Leucker, MD, PhD
First Name & Middle Initial & Last Name & Degree
Gary Gerstenblith, MD
First Name & Middle Initial & Last Name & Degree
Tarek Harb, MD
First Name & Middle Initial & Last Name & Degree
Efthymios Ziogos, MD
First Name & Middle Initial & Last Name & Degree
Allison Hays, MD
First Name & Middle Initial & Last Name & Degree
Robert Weiss, MD
First Name & Middle Initial & Last Name & Degree
Mike Schaer, PhD

12. IPD Sharing Statement

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Vericiguat in Patients With Metabolic Syndrome and Coronary Vascular Dysfunction

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