Trial Outcomes & Findings for Post-Acute Sequelae of Coronavirus-19 (COVID-19) With Dyspnea on Exertion And Associated TaChycardia TrEatment Study (NCT NCT05096884)

NCT ID: NCT05096884

Last Updated: 2024-12-03

Results Overview

To assess the reduction of symptoms in patients with PASC Dyspnea on Exertion (DOE) and associated tachycardia when treated with beta blockers as captured in patients walk test. Walk test will be performed at day 1 (baseline) and at 2-4 weeks post treatment completion which consists of 8 weeks metoprolol succinate (approximately 12 weeks from baseline).

• Recruitment status: TERMINATED
• Study phase: EARLY_PHASE1
• Target enrollment: 14 participants
• Primary outcome timeframe: 12 weeks from baseline walk test
• Results posted on: 2024-12-03

Participant Flow

Participant milestones

Measure	Study Arm - Metoprolol Succinate. The beta blocker metoprolol succinate will be initiated at a starting low dose of 25 mg daily for two weeks and will be escalated if well tolerated every 2 weeks to a maximum dose of 400 mg po daily. Metoprolol Succinate: The beta blocker metoprolol succinate will be initiated at a starting low dose of 25 mg daily for two weeks and will be escalated if well tolerated every 2 weeks to a maximum dose of 400 mg po daily.
Overall Study STARTED	14
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure

Study Arm - Metoprolol Succinate. The beta blocker metoprolol succinate will be initiated at a starting low dose of 25 mg daily for two weeks and will be escalated if well tolerated every 2 weeks to a maximum dose of 400 mg po daily. Metoprolol Succinate: The beta blocker metoprolol succinate will be initiated at a starting low dose of 25 mg daily for two weeks and will be escalated if well tolerated every 2 weeks to a maximum dose of 400 mg po daily.

Overall Study Excluded based on negative tilt table test

4

Baseline Characteristics

Post-Acute Sequelae of Coronavirus-19 (COVID-19) With Dyspnea on Exertion And Associated TaChycardia TrEatment Study

Baseline characteristics by cohort

Measure	Study Arm - Metoprolol Succinate. n=10 Participants The beta blocker metoprolol succinate will be initiated at a starting low dose of 25 mg daily for two weeks and will be escalated if well tolerated every 2 weeks to a maximum dose of 400 mg po daily. Metoprolol Succinate: The beta blocker metoprolol succinate will be initiated at a starting low dose of 25 mg daily for two weeks and will be escalated if well tolerated every 2 weeks to a maximum dose of 400 mg po daily.
Age, Continuous	42.5 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	1 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks from baseline walk test

Population: Total distance walked within 6 minutes

To assess the reduction of symptoms in patients with PASC Dyspnea on Exertion (DOE) and associated tachycardia when treated with beta blockers as captured in patients walk test. Walk test will be performed at day 1 (baseline) and at 2-4 weeks post treatment completion which consists of 8 weeks metoprolol succinate (approximately 12 weeks from baseline).

Outcome measures

Measure	Study Arm - Metoprolol Succinate. n=10 Participants The beta blocker metoprolol succinate will be initiated at a starting low dose of 25 mg daily for two weeks and will be escalated if well tolerated every 2 weeks to a maximum dose of 400 mg po daily. Metoprolol Succinate: The beta blocker metoprolol succinate will be initiated at a starting low dose of 25 mg daily for two weeks and will be escalated if well tolerated every 2 weeks to a maximum dose of 400 mg po daily.
Change in 6 Minute Walk Test at the End of Treatment Period Distance walked at baseline	275 meters Standard Deviation 76
Change in 6 Minute Walk Test at the End of Treatment Period Distance walked post treatment	339 meters Standard Deviation 76

PRIMARY outcome

Timeframe: 12 weeks from baseline transthoracic echocardiogram (TTE).

Population: Zva measurement in (mmHg mL\^-1) m\^2

To assess the reduction of symptoms in patients with PASC Dyspnea on Exertion (DOE) and associated tachycardia when treated with beta blockers as captured in Zva measurement calculated from patient's TTE (transthoracic echocardiogram).

TTE (and Zva) will be performed at day 1 (baseline) and at 2-4 weeks post treatment completion which consists of 8 weeks metoprolol succinate (approximately 12 weeks from baseline).

Outcome measures

Measure	Study Arm - Metoprolol Succinate. n=10 Participants The beta blocker metoprolol succinate will be initiated at a starting low dose of 25 mg daily for two weeks and will be escalated if well tolerated every 2 weeks to a maximum dose of 400 mg po daily. Metoprolol Succinate: The beta blocker metoprolol succinate will be initiated at a starting low dose of 25 mg daily for two weeks and will be escalated if well tolerated every 2 weeks to a maximum dose of 400 mg po daily.
Change in Zva Measurement at the End of Treatment Period Zva at baseline	4.24 (mmHg mL^-1) m^2 Standard Deviation 0.83
Change in Zva Measurement at the End of Treatment Period Zva post treatment	3.70 (mmHg mL^-1) m^2 Standard Deviation 0.72

SECONDARY outcome

Timeframe: 12 weeks from baseline

Population: Mean of total score in the Minnesota Living with Heart Failure.

Subjective improvement in Dyspnea on Exertion (DOE), tachycardia and well being score as measured by the Minnesota Living with Heart Failure.

The Minnesota Living with Heart Failure questionnaire will be administered at day 1 (baseline) and at 2-4 weeks post treatment completion which consists of 8 weeks metoprolol succinate (approximately 12 weeks from baseline). Minnesota Living with Heart Failure questionnaire is a 21-item questionnaire with each item having a 6 point Likert scale (0-5), Zero represents "No symptom" and 5 represents high intensity of symptom. The questionnaire has 3 dimension and they measure Physical, socio-economic and emotional/psychological aspects respectively. The total score is the sum of all item responses for total and dimension scores.

Outcome measures

Measure	Study Arm - Metoprolol Succinate. n=10 Participants The beta blocker metoprolol succinate will be initiated at a starting low dose of 25 mg daily for two weeks and will be escalated if well tolerated every 2 weeks to a maximum dose of 400 mg po daily. Metoprolol Succinate: The beta blocker metoprolol succinate will be initiated at a starting low dose of 25 mg daily for two weeks and will be escalated if well tolerated every 2 weeks to a maximum dose of 400 mg po daily.
Change in Minnesota Living With Heart Failure Score at the End of Treatment Period Minnesota Living with Heart Failure scale post treatment	52 score on a scale Standard Deviation 18
Change in Minnesota Living With Heart Failure Score at the End of Treatment Period Minnesota Living with Heart Failure scale at baseline	74 score on a scale Standard Deviation 16

Adverse Events

Study Arm - Metoprolol Succinate.

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

Study Arm - Metoprolol Succinate. n=10 participants at risk The beta blocker metoprolol succinate will be initiated at a starting low dose of 25 mg daily for two weeks and will be escalated if well tolerated every 2 weeks to a maximum dose of 400 mg po daily. Metoprolol Succinate: The beta blocker metoprolol succinate will be initiated at a starting low dose of 25 mg daily for two weeks and will be escalated if well tolerated every 2 weeks to a maximum dose of 400 mg po daily.

Cardiac disorders Symptomatic hypotension

10.0% 1/10 • Number of events 1 • Patients were monitored for AEs/SAEs for the duration of treatment (up to 12 weeks) Self reported AEs/SAEs

Additional Information

Jana Tancredi

Hackensack Meridian Health

Phone: 5519962353

Email: Jana.Tancredi@hmhn.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place