NCT01917136

Brief Summary

This study is looking at differences in metabolism and functional imaging between pulmonary hypertension subjects with normal right ventricular function and persistent right ventricular dysfunction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2013

Longer than P75 for phase_2

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

Study Start

First participant enrolled

August 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2013

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
4 months until next milestone

Results Posted

Study results publicly available

February 5, 2019

Completed
Last Updated

February 5, 2019

Status Verified

November 1, 2018

Enrollment Period

5.2 years

First QC Date

August 3, 2013

Results QC Date

November 30, 2018

Last Update Submit

January 14, 2019

Conditions

Pulmonary Hypertension

Keywords

pulmonary hypertensionright ventricular function11C acetateFDGranolazine

Outcome Measures

Primary Outcomes (1)

  • Changes in RV Function

    RV function as measured by cardiac MRI

    6 months

Study Arms (1)

11c-acetate and 18F-FDG, and cardiac MRI

EXPERIMENTAL

For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate and a 10 millicurie injection of 18F-FDG At baseline/6 months follow up, a cardiac MRI will be performed.

Drug: 11C-acetateDrug: [18F]Fluoro-2-deoxy-2-D-glucoseOther: Cardiac MRI

Interventions

11C-acetateDRUG

For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate

11c-acetate and 18F-FDG, and cardiac MRI
[18F]Fluoro-2-deoxy-2-D-glucoseDRUG

For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG

Also known as: 18F-FDG
11c-acetate and 18F-FDG, and cardiac MRI
Cardiac MRIOTHER

Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups.

11c-acetate and 18F-FDG, and cardiac MRI

Eligibility Criteria

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

You may qualify if:

  • Participation in the companion treatment protocol "A randomized, double-blind, placebo controlled, multi-center study to assess the effect of ranolazine on outcomes in subjects with pulmonary hypertension and right ventricular dysfunction accompanied by a comparative study of cellular metabolism in subjects with pulmonary hypertension with and without right ventricular dysfunction"

You may not qualify if:

  • Pregnancy or lactation: Women of childbearing potential must have a negative urine or blood pregnancy test on the day of the PET/CT scan.
  • Severe anxiety or claustrophobia prohibiting completion of imaging
  • Inability to tolerate imaging procedures (1 hour MRI, 30 min and 15 min PET)
  • Implantable cardioverter-defibrillator, Pacemaker, hazardous metallic implants or any other contraindication to MRI.
  • Uncontrolled diabetes mellitus with fasting glucose \> 150 mg/dL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

carbon-11 acetateFluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydrates

Results Point of Contact

Title
Dr. Yuchi Han
Organization
University of Pennsylvania
yuchi.han@uphs.upenn.edu
215-662-2855

Study Officials

  • Yuchi Han, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2013

First Posted

August 6, 2013

Study Start

August 1, 2013

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

February 5, 2019

Results First Posted

February 5, 2019

Record last verified: 2018-11

Locations

US(1)