Trial Outcomes & Findings for Right Ventricular Hemodynamics Using Cardiac MRI in Patients COPD and OSA (NCT NCT02244957)

NCT ID: NCT02244957

Last Updated: 2020-07-28

Results Overview

Defined as the ratio between RVMI and RV end-diastolic volume index using MRI

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

Six months

Results posted on

2020-07-28

Participant Flow

Participant milestones

Participant milestones
Measure	Chronic Obstructive Pulmonary Disease (COPD) Subjects with only Chronic Obstructive Pulmonary Disease (COPD)	Overlap Syndrome Subjects with simultaneous Obstructive Sleep Apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD). The dual diagnosis of these two conditions is referred to as Overlap Syndrome.
Overall Study STARTED	7	16
Overall Study COMPLETED	6	16
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Chronic Obstructive Pulmonary Disease (COPD) Subjects with only Chronic Obstructive Pulmonary Disease (COPD)	Overlap Syndrome Subjects with simultaneous Obstructive Sleep Apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD). The dual diagnosis of these two conditions is referred to as Overlap Syndrome.
Overall Study Lack of Efficacy	1	0

Baseline Characteristics

Right Ventricular Hemodynamics Using Cardiac MRI in Patients COPD and OSA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chronic Obstructive Pulmonary Disease (COPD) n=6 Participants Subjects with only Chronic Obstructive Pulmonary Disease (COPD).	Overlap Syndrome n=16 Participants Subjects with simultaneous Obstructive Sleep Apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD). The dual diagnosis of these two conditions is referred to as Overlap Syndrome.	Total n=22 Participants Total of all reporting groups
Age, Continuous	64 years STANDARD_DEVIATION 6.4 • n=5 Participants	63.5 years STANDARD_DEVIATION 4.2 • n=7 Participants	63.9 years STANDARD_DEVIATION 5.8 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	14 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	13 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	16 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: Six months

Population: one subject was dropped due to lack of efficacy

Defined as the ratio between RVMI and RV end-diastolic volume index using MRI

Outcome measures

Outcome measures
Measure	Chronic Obstructive Pulmonary Disease (COPD) n=6 Participants Subjects with only Chronic Obstructive Pulmonary Disease (COPD).	Overlap Syndrome n=16 Participants Subjects with simultaneous Obstructive Sleep Apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD). The dual diagnosis of these two conditions is referred to as Overlap Syndrome.
Right Ventricular Remodeling Index	0.3747 ratio Standard Deviation 0.06335	0.2817 ratio Standard Deviation 0.03630

SECONDARY outcome

Timeframe: Six months

Population: No data collected as study was terminated prior to randomization

MRI

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Six months

Population: No data collected as study was terminated prior to randomization

MRI

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Six months

Population: No data collected as study was terminated prior to randomization

MRI

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Six months

Population: No data collected as study was terminated prior to randomization

MRI

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Six months

Population: No data collected as study was terminated prior to randomization

MRI

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Six months

Population: No data collected as study was terminated prior to randomization

MRI

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No data collected as study was terminated prior to randomization

MRI

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No data collected as study was terminated prior to randomization

MRI

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No data collected as study was terminated prior to randomization

blood test

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No data collected as study was terminated prior to randomization

blood test

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No data collected as study was terminated prior to randomization

blood test

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No data collected as study was terminated prior to randomization

blood test

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No data collected as study was terminated prior to randomization

Blood test

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No data collected as study was terminated prior to randomization

Urine test

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No data collected as study was terminated prior to randomization

Low-grade physical activity test

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No data collected as study was terminated prior to randomization

Questionnaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No data collected as study was terminated prior to randomization

Questionnaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No data collected as study was terminated prior to randomization

Questionnaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No data collected as study was terminated prior to randomization

Questionnaire

Outcome measures

Outcome data not reported

Adverse Events

Chronic Obstructive Pulmonary Disease (COPD)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Overlap Syndrome

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

Dillon Gilbertson

UCSD

Phone: 8582452155

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place