Trial Outcomes & Findings for A Method Validation Study for Evaluation of Novel Treatments Limiting Pulmonary Oedema in Cardiac Failure (NCT NCT02135861)
NCT ID: NCT02135861
Last Updated: 2019-02-27
Results Overview
Interstitial volume (ve) was measured by DCE-MRI. ve for total lung, left lung, right lung, left lung apical, left lung basal, right lung apical, right lung basal has been presented. Session 1 values were considered as Baseline values.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
41 participants
Primary outcome timeframe
Day 1
Results posted on
2019-02-27
Participant Flow
This study included healthy volunteers (HV, group 1), participants (par) with heart failure (HF, group 2) and participants with acute decompensated heart failure (ADHF, group 3) who were hospitalized with evidence of pulmonary edema and received standard of care treatment.
Dynamic Contrast Enhanced-Magnetic Resonance Imaging (DCE-MRI) markers were used to measure vascular permeability and pulmonary edema in HV and par. with HF. Forty one par. were enrolled and 36 entered the study. Three par. did not continue due to habitus and 2 par. did not participate as they required clinical investigations.
Participant milestones
| Measure |
Healthy Volunteers
Healthy volunteers were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
|
Heart Failure Participants
Heart failure participants were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
|
Acute Decompensated Heart Failure Participants
Acute Decompensated Heart Failure participants following hospitalization due to pulmonary oedema was placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
12
|
3
|
|
Overall Study
COMPLETED
|
21
|
12
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Method Validation Study for Evaluation of Novel Treatments Limiting Pulmonary Oedema in Cardiac Failure
Baseline characteristics by cohort
| Measure |
Healthy Volunteers
n=21 Participants
Healthy volunteers were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
|
Heart Failure Participants
n=12 Participants
Heart failure participants were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
|
Acute Decompensated Heart Failure Participants
n=3 Participants
Acute Decompensated Heart Failure participants following hospitalization due to pulmonary oedema was placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.8 Years
STANDARD_DEVIATION 18.66 • n=5 Participants
|
67.8 Years
STANDARD_DEVIATION 13.42 • n=7 Participants
|
79.3 Years
STANDARD_DEVIATION 4.93 • n=5 Participants
|
66.9 Years
STANDARD_DEVIATION 6.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: The Evaluable Population will include participants in safety population who are 40 years and older .The safety Population includes all enrolled participants who have initiated Session 1 DCE-MRI scan
Interstitial volume (ve) was measured by DCE-MRI. ve for total lung, left lung, right lung, left lung apical, left lung basal, right lung apical, right lung basal has been presented. Session 1 values were considered as Baseline values.
Outcome measures
| Measure |
Healthy Volunteers
n=17 Participants
Healthy volunteers were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
|
Heart Failure Participants
n=12 Participants
Heart failure participants were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
|
|---|---|---|
|
Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers at Baseline
Right lung apical
|
0.4865 Liter
Standard Error 0.0392
|
0.3506 Liter
Standard Error 0.0352
|
|
Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers at Baseline
Right lung basal
|
0.5045 Liter
Standard Error 0.0444
|
0.3297 Liter
Standard Error 0.0390
|
|
Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers at Baseline
Total lung
|
0.4946 Liter
Standard Error 0.0362
|
0.3346 Liter
Standard Error 0.0325
|
|
Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers at Baseline
Left lung
|
0.5078 Liter
Standard Error 0.0349
|
0.3253 Liter
Standard Error 0.0317
|
|
Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers at Baseline
Right lung
|
0.4960 Liter
Standard Error 0.0417
|
0.3395 Liter
Standard Error 0.0371
|
|
Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers at Baseline
Left lung apical
|
0.4952 Liter
Standard Error 0.0339
|
0.3188 Liter
Standard Error 0.0306
|
|
Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers at Baseline
Left lung basal
|
0.5349 Liter
Standard Error 0.0397
|
0.3350 Liter
Standard Error 0.0362
|
PRIMARY outcome
Timeframe: Day 1Population: The Evaluable Population
Exchange rate (Ktrans) was measured by DCE-MRI. Ktrans for total lung, left lung, right lung, left lung apical, left lung basal, right lung apical, right lung basal has been presented. Session 1 values were considered as Baseline values.
Outcome measures
| Measure |
Healthy Volunteers
n=12 Participants
Healthy volunteers were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
|
Heart Failure Participants
n=17 Participants
Heart failure participants were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
|
|---|---|---|
|
Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers at Baseline
Total lung
|
0.2216 Liter/minute
Standard Error 0.0298
|
0.2353 Liter/minute
Standard Error 0.0273
|
|
Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers at Baseline
Left lung
|
0.2309 Liter/minute
Standard Error 0.0256
|
0.2173 Liter/minute
Standard Error 0.0236
|
|
Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers at Baseline
Left lung apical
|
0.2166 Liter/minute
Standard Error 0.0265
|
0.2161 Liter/minute
Standard Error 0.0244
|
|
Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers at Baseline
Left lung basal
|
0.2621 Liter/minute
Standard Error 0.0270
|
0.2225 Liter/minute
Standard Error 0.0249
|
|
Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers at Baseline
Right lung apical
|
0.2166 Liter/minute
Standard Error 0.0355
|
0.2528 Liter/minute
Standard Error 0.0326
|
|
Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers at Baseline
Right lung basal
|
0.2313 Liter/minute
Standard Error 0.0329
|
0.2431 Liter/minute
Standard Error 0.0301
|
|
Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers at Baseline
Right lung
|
0.2216 Liter/minute
Standard Error 0.0338
|
0.2474 Liter/minute
Standard Error 0.0309
|
PRIMARY outcome
Timeframe: Day 11Population: The Evaluable Population
Interstitial volume (ve) was measured by DCE-MRI. ve for total lung, left lung, right lung, left lung apical, left lung basal, right lung apical, right lung basal before and following exercise has been presented.
Outcome measures
| Measure |
Healthy Volunteers
n=12 Participants
Healthy volunteers were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
|
Heart Failure Participants
n=17 Participants
Heart failure participants were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
|
|---|---|---|
|
Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Pre-exercise; Total lung
|
0.4353 Liter
Standard Error 0.0335
|
0.3205 Liter
Standard Error 0.0292
|
|
Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Post-exercise; Left lung
|
0.4832 Liter
Standard Error 0.0266
|
0.3055 Liter
Standard Error 0.0228
|
|
Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Post-exercise; Right lung
|
0.4534 Liter
Standard Error 0.0355
|
0.3274 Liter
Standard Error 0.0298
|
|
Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Pre-exercise; Left lung apical
|
0.4272 Liter
Standard Error 0.0335
|
0.3126 Liter
Standard Error 0.0289
|
|
Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Pre-exercise; Left lung basal
|
0.4890 Liter
Standard Error 0.0318
|
0.3114 Liter
Standard Error 0.0272
|
|
Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Post-exercise; Left lung basal
|
0.5310 Liter
Standard Error 0.0323
|
0.3173 Liter
Standard Error 0.0276
|
|
Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Pre-exercise; Right lung apical
|
0.4343 Liter
Standard Error 0.0378
|
0.3387 Liter
Standard Error 0.0324
|
|
Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Post-exercise; Right lung apical
|
0.4504 Liter
Standard Error 0.0358
|
0.3393 Liter
Standard Error 0.0301
|
|
Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Post-exercise; Total lung
|
0.4568 Liter
Standard Error 0.0307
|
0.3140 Liter
Standard Error 0.0263
|
|
Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Pre-exercise; Left lung
|
0.4487 Liter
Standard Error 0.0311
|
0.3121 Liter
Standard Error 0.0267
|
|
Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Pre-exercise; Right lung
|
0.4361 Liter
Standard Error 0.0357
|
0.3294 Liter
Standard Error 0.0311
|
|
Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Post-exercise; Left lung apical
|
0.4449 Liter
Standard Error 0.0257
|
0.2986 Liter
Standard Error 0.0216
|
|
Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Pre-exercise; Right lung basal
|
0.4400 Liter
Standard Error 0.0347
|
0.3206 Liter
Standard Error 0.0301
|
|
Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Post-exercise; Right lung basal
|
0.4591 Liter
Standard Error 0.0367
|
0.3133 Liter
Standard Error 0.0308
|
PRIMARY outcome
Timeframe: Day 11Population: The Evaluable Population
Exchange rate (Ktrans) was measured by DCE-MRI. Ktrans for total lung, left lung, right lung, left lung apical, left lung basal, right lung apical, right lung basal before and following exercise has been presented.
Outcome measures
| Measure |
Healthy Volunteers
n=12 Participants
Healthy volunteers were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
|
Heart Failure Participants
n=17 Participants
Heart failure participants were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
|
|---|---|---|
|
Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Pre-exercise; Left lung
|
0.2102 Liter/minute
Standard Error 0.0285
|
0.2525 Liter/minute
Standard Error 0.0245
|
|
Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Post-exercise; Left lung
|
0.1785 Liter/minute
Standard Error 0.0200
|
0.1986 Liter/minute
Standard Error 0.0172
|
|
Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Pre-exercise; Right lung
|
0.2034 Liter/minute
Standard Error 0.0299
|
0.2550 Liter/minute
Standard Error 0.0263
|
|
Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Pre-exercise; Left lung apical
|
0.1856 Liter/minute
Standard Error 0.0293
|
0.2459 Liter/minute
Standard Error 0.0253
|
|
Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Post-exercise; Left lung apical
|
0.1621 Liter/minute
Standard Error 0.0199
|
0.1780 Liter/minute
Standard Error 0.0167
|
|
Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Pre-exercise; Left lung basal
|
0.2552 Liter/minute
Standard Error 0.0296
|
0.2630 Liter/minute
Standard Error 0.0254
|
|
Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Post-exercise; Right lung
|
0.1926 Liter/minute
Standard Error 0.0269
|
0.2114 Liter/minute
Standard Error 0.0226
|
|
Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Post-exercise; Left lung basal
|
0.2060 Liter/minute
Standard Error 0.0227
|
0.2185 Liter/minute
Standard Error 0.0196
|
|
Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Pre-exercise; Right lung apical
|
0.1934 Liter/minute
Standard Error 0.0281
|
0.2440 Liter/minute
Standard Error 0.0243
|
|
Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Post-exercise; Right lung apical
|
0.1892 Liter/minute
Standard Error 0.0267
|
0.2141 Liter/minute
Standard Error 0.0224
|
|
Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Pre-exercise; Right lung basal
|
0.2181 Liter/minute
Standard Error 0.0319
|
0.2593 Liter/minute
Standard Error 0.0281
|
|
Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Post-exercise; Right lung basal
|
0.2052 Liter/minute
Standard Error 0.0284
|
0.2081 Liter/minute
Standard Error 0.0238
|
|
Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Pre-exercise; Total lung
|
0.2044 Liter/minute
Standard Error 0.0281
|
0.2567 Liter/minute
Standard Error 0.0247
|
|
Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Post-exercise; Total lung
|
0.1841 Liter/minute
Standard Error 0.0221
|
0.2108 Liter/minute
Standard Error 0.0190
|
PRIMARY outcome
Timeframe: Up to Week 8Population: The safety population will include all enrolled participants who have initiated at least one session of DCE-MRI or Lung Ultrasound Scan
Interstitial volume (ve) was measured by DCE-MRI. Three participants underwent 3 DCE-MRI scans. The data has been presented for individual participant in each session. The data presented below is only for total lung.
Outcome measures
| Measure |
Healthy Volunteers
n=3 Participants
Healthy volunteers were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
|
Heart Failure Participants
Heart failure participants were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
|
|---|---|---|
|
Change in Interstitial Volume (ve) in ADHF Participants
Par.1; Session 1
|
0.794 Liter
|
—
|
|
Change in Interstitial Volume (ve) in ADHF Participants
Par.1; Session 2
|
0.9577 Liter
|
—
|
|
Change in Interstitial Volume (ve) in ADHF Participants
Par. 2; Session 1
|
0.5086 Liter
|
—
|
|
Change in Interstitial Volume (ve) in ADHF Participants
Par. 2; Session 2
|
0.4018 Liter
|
—
|
|
Change in Interstitial Volume (ve) in ADHF Participants
Par. 3; Session 1
|
0.354 Liter
|
—
|
|
Change in Interstitial Volume (ve) in ADHF Participants
Par. 3; Session 2
|
0.6356 Liter
|
—
|
|
Change in Interstitial Volume (ve) in ADHF Participants
Par. 3 Session 3
|
0.6083 Liter
|
—
|
PRIMARY outcome
Timeframe: Up to Week 8Population: The Safety Population
Exchange rate (Ktrans) was measured by DCE-MRI. Three participants underwent 3 DCE-MRI scans. The data has been presented for individual participant in each session. The data presented below is only for total lung.
Outcome measures
| Measure |
Healthy Volunteers
n=3 Participants
Healthy volunteers were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
|
Heart Failure Participants
Heart failure participants were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
|
|---|---|---|
|
Change in Exchange Rate (Ktrans) in ADHF Participants
Par.1; Session 1
|
0.4524 Liter/minute
|
—
|
|
Change in Exchange Rate (Ktrans) in ADHF Participants
Par.1; Session 2
|
0.5306 Liter/minute
|
—
|
|
Change in Exchange Rate (Ktrans) in ADHF Participants
Par. 2; Session 1
|
0.3018 Liter/minute
|
—
|
|
Change in Exchange Rate (Ktrans) in ADHF Participants
Par. 2; Session 2
|
0.1952 Liter/minute
|
—
|
|
Change in Exchange Rate (Ktrans) in ADHF Participants
Par. 3; Session 1
|
0.1602 Liter/minute
|
—
|
|
Change in Exchange Rate (Ktrans) in ADHF Participants
Par. 3; Session 2
|
0.4304 Liter/minute
|
—
|
|
Change in Exchange Rate (Ktrans) in ADHF Participants
Par. 3 Session 3
|
0.4264 Liter/minute
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Session 1) and Day 9 (Session 2)Population: The Evaluable Population
Coefficient of variation (percentage) of intra-subject variability in Ve between Session 1 and Session 2 for total lung has been presented.
Outcome measures
| Measure |
Healthy Volunteers
n=12 Participants
Healthy volunteers were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
|
Heart Failure Participants
n=17 Participants
Heart failure participants were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
|
|---|---|---|
|
Assessment of Intra-subject Variability in Ve Between Session 1 and Session 2 of DCE-MRI
|
20.5 Percentage
|
14.1 Percentage
|
SECONDARY outcome
Timeframe: Day 1 (Session 1) and Day 9 (Session 2)Population: The Evaluable Population
Coefficient of variation (percentage) of intra-subject variability in Ktrans between Session 1 and Session 2 for total lung has been presented.
Outcome measures
| Measure |
Healthy Volunteers
n=12 Participants
Healthy volunteers were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
|
Heart Failure Participants
n=17 Participants
Heart failure participants were placed in supine position under the scanner and intravenous contrast agent was administered. Contrast agent was administered as a bolus using a power injector during the dynamic series. MRI scanning was conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
|
|---|---|---|
|
Assessment of Intra-subject Variability in Ktrans Between Session 1 and Session 2 of DCE-MRI
|
32.4 Percentage
|
41.3 Percentage
|
Adverse Events
Healthy Volunteers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Heart Failure Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Acute Decompensated Heart Failure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER