Trial Outcomes & Findings for Pressure Assessment to Improve Outcomes After TAVR: a Registry (NCT NCT03923530)

Results Overview

The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a self-administered health status survey. The KCCQ-12 has 4 domains (physical limitation, symptom frequency, quality of life, social limitation) and one summary score. Score are scaled 0-100, where 1 denotes the lowest reportable health status and 100 the highest.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

12 participants

Primary outcome timeframe

Baseline, 8 weeks

Results posted on

2020-05-28

Participant Flow

Recruitment at Malcom Randall VA Medical Center

Participant milestones

Participant milestones
Measure	Eplerenone All subjects will receive eplerenone 50 mg daily. The Kansas City Cardiomyopathy Questionnaire-12 will be administered at baseline and 8 weeks. Serum potassium within the last 30 days is required before initiating eplerenone, repeat blood draw within the first week of starting eplerenone and at 4 weeks.
Overall Study STARTED	12
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Eplerenone All subjects will receive eplerenone 50 mg daily. The Kansas City Cardiomyopathy Questionnaire-12 will be administered at baseline and 8 weeks. Serum potassium within the last 30 days is required before initiating eplerenone, repeat blood draw within the first week of starting eplerenone and at 4 weeks.
Overall Study Withdrawal by Subject	1
Overall Study screen failure	3

Baseline Characteristics

Pressure Assessment to Improve Outcomes After TAVR: a Registry

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eplerenone n=12 Participants All subjects will receive study drug daily. Eplerenone: 50mg daily Kansas City Cardiomyopathy Questionnaire: administered at baseline and 8 weeks Serum potassium: within the last 30 days is required before initiating eplerenone, repeat blood draw within the first week and starting eplerenone and 4 weeks after starting eplerenone
Age, Continuous	73.1 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 8 weeks

The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a self-administered health status survey. The KCCQ-12 has 4 domains (physical limitation, symptom frequency, quality of life, social limitation) and one summary score. Score are scaled 0-100, where 1 denotes the lowest reportable health status and 100 the highest.

Outcome measures

Outcome measures
Measure	Eplerenone n=8 Participants Eplerenone 50 mg daily administered orally to subjects
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)-Summary Score Baseline	59.4 score on a scale Standard Deviation 19.7
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)-Summary Score 8 weeks	74.1 score on a scale Standard Deviation 20.0

SECONDARY outcome

Timeframe: Baseline, 8 weeks

The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a self-administered health status survey. The KCCQ-12 has 4 domains (physical limitation, symptom frequency, quality of life, social limitation) and one summary score. Score are scaled 0-100, where 1 denotes the lowest reportable health status and 100 the highest.

Outcome measures

Outcome measures
Measure	Eplerenone n=8 Participants Eplerenone 50 mg daily administered orally to subjects
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)-Physical Limitation Score Baseline	53.0 score on a scale Standard Deviation 21.4
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)-Physical Limitation Score 8 weeks	61.5 score on a scale Standard Deviation 14.8

SECONDARY outcome

Timeframe: Baseline, 8 weeks

The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a self-administered health status survey. The KCCQ-12 has 4 domains (physical limitation, symptom frequency, quality of life, social limitation) and one summary score. Score are scaled 0-100, where 1 denotes the lowest reportable health status and 100 the highest.

Outcome measures

Outcome measures
Measure	Eplerenone n=8 Participants Eplerenone 50 mg daily administered orally to subjects
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)-Symptom Frequency Score Baseline	63.5 score on a scale Standard Deviation 20.7
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)-Symptom Frequency Score 8 weeks	81.5 score on a scale Standard Deviation 14.4

SECONDARY outcome

Timeframe: Baseline, 8 weeks

The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a self-administered health status survey. The KCCQ-12 has 4 domains (physical limitation, symptom frequency, quality of life, social limitation) and one summary score. Score are scaled 0-100, where 1 denotes the lowest reportable health status and 100 the highest.

Outcome measures

Outcome measures
Measure	Eplerenone n=8 Participants Eplerenone 50 mg daily administered orally to subjects
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)-Quality of Life Score Baseline	54.9 score on a scale Standard Deviation 40.5
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)-Quality of Life Score 8 weeks	73.6 score on a scale Standard Deviation 30.8

SECONDARY outcome

Timeframe: Baseline, 8 weeks

The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a self-administered health status survey. The KCCQ-12 has 4 domains (physical limitation, symptom frequency, quality of life, social limitation) and one summary score. Score are scaled 0-100, where 1 denotes the lowest reportable health status and 100 the highest.

Outcome measures

Outcome measures
Measure	Eplerenone n=8 Participants Eplerenone 50 mg daily administered orally to subjects
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)-Social Limitation Score Baseline	65.6 score on a scale Standard Deviation 32.2
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)-Social Limitation Score 8 weeks	80.1 score on a scale Standard Deviation 26.0

SECONDARY outcome

Timeframe: Baseline, 8 weeks

Cuff systolic blood pressure

Outcome measures

Outcome measures
Measure	Eplerenone n=8 Participants Eplerenone 50 mg daily administered orally to subjects
Systolic Blood Pressure Baseline	122.5 mm Hg Standard Deviation 16.5
Systolic Blood Pressure 8 weeks	120.0 mm Hg Standard Deviation 26.3

SECONDARY outcome

Timeframe: Baseline, 8 weeks

Cuff diastolic blood pressure

Outcome measures

Outcome measures
Measure	Eplerenone n=8 Participants Eplerenone 50 mg daily administered orally to subjects
Diastolic Blood Pressure Baseline	56.2 mm Hg Standard Deviation 7.7
Diastolic Blood Pressure 8 weeks	55.0 mm Hg Standard Deviation 6.2

Adverse Events

Eplerenone

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

Dr. Anthony Bavry

NF South Ga VAMC

Phone: 352-548-4726

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place